Regional anesthesia considerations for cardiac surgery.

Pain is a significant consequence of cardiac surgery and newer techniques in cardiac anesthesia have provided an impetus for the development of multimodal techniques to manage acute pain in this setting. In this regard, regional anesthesia techniques have been increasingly used in many cardiac surgical procedures, for the purposes of reducing perioperative consumption of opioid agents and enhanced recovery after surgery. The present investigation focuses on most currently used regional techniques in cardiac surgical procedures. These regional techniques include chest wall blocks (e.g., PECS I and II, SAP, ESB, PVB), sternal blocks (e.g., TTMPB, PSINB), and neuraxial blocks (e.g., TEA, high spinal anesthesia). The present investigation also summarizes indications, technique, complications, and potential clinical benefits of these evolving regional techniques. Cardiac surgery patients may benefit from application of these regional techniques with well controlled indications and careful patient selections.

An update of comprehensive evidence-based guidelines for interventional techniques in chronic spinal pain. Part II: guidance and recommendations.

OBJECTIVE: To develop evidence-based clinical practice guidelines for interventional techniques in the diagnosis and treatment of chronic spinal pain. METHODOLOGY: Systematic assessment of the literature. EVIDENCE: I. Lumbar Spine • The evidence for accuracy of diagnostic selective nerve root blocks is limited; whereas for lumbar provocation discography, it is fair. • The evidence for diagnostic lumbar facet joint nerve blocks and diagnostic sacroiliac intraarticular injections is good with 75% to 100% pain relief as criterion standard with controlled local anesthetic or placebo blocks. • The evidence is good in managing disc herniation or radiculitis for caudal, interlaminar, and transforaminal epidural injections; fair for axial or discogenic pain without disc herniation, radiculitis or facet joint pain with caudal, and interlaminar epidural injections, and limited for transforaminal epidural injections; fair for spinal stenosis with caudal, interlaminar, and transforaminal epidural injections; and fair for post surgery syndrome with caudal epidural injections and limited with transforaminal epidural injections. • The evidence for therapeutic facet joint interventions is good for conventional radiofrequency, limited for pulsed radiofrequency, fair to good for lumbar facet joint nerve blocks, and limited for intraarticular injections. • For sacroiliac joint interventions, the evidence for cooled radiofrequency neurotomy is fair; limited for intraarticular injections and periarticular injections; and limited for both pulsed radiofrequency and conventional radiofrequency neurotomy. • For lumbar percutaneous adhesiolysis, the evidence is fair in managing chronic low back and lower extremity pain secondary to post surgery syndrome and spinal stenosis. • For intradiscal procedures, the evidence for intradiscal electrothermal therapy (IDET) and biaculoplasty is limited to fair and is limited for discTRODE. • For percutaneous disc decompression, the evidence is limited for automated percutaneous lumbar discectomy (APLD), percutaneous lumbar laser disc decompression, and Dekompressor; and limited to fair for nucleoplasty for which the Centers for Medicare and Medicaid Services (CMS) has issued a noncoverage decision. II. Cervical Spine • The evidence for cervical provocation discography is limited; whereas the evidence for diagnostic cervical facet joint nerve blocks is good with a criterion standard of 75% or greater relief with controlled diagnostic blocks. • The evidence is good for cervical interlaminar epidural injections for cervical disc herniation or radiculitis; fair for axial or discogenic pain, spinal stenosis, and post cervical surgery syndrome. • The evidence for therapeutic cervical facet joint interventions is fair for conventional cervical radiofrequency neurotomy and cervical medial branch blocks, and limited for cervical intraarticular injections. III. Thoracic Spine • The evidence is limited for thoracic provocation discography and is good for diagnostic accuracy of thoracic facet joint nerve blocks with a criterion standard of at least 75% pain relief with controlled diagnostic blocks. • The evidence is fair for thoracic epidural injections in managing thoracic pain. • The evidence for therapeutic thoracic facet joint nerve blocks is fair, limited for radiofrequency neurotomy, and not available for thoracic intraarticular injections. IV. Implantables • The evidence is fair for spinal cord stimulation (SCS) in managing patients with failed back surgery syndrome (FBSS) and limited for implantable intrathecal drug administration systems. V. ANTICOAGULATION • There is good evidence for risk of thromboembolic phenomenon in patients with antithrombotic therapy if discontinued, spontaneous epidural hematomas with or without traumatic injury in patients with or without anticoagulant therapy to discontinue or normalize INR with warfarin therapy, and the lack of necessity of discontinuation of nonsteroidal anti-inflammatory drugs (NSAIDs), including low dose aspirin prior to performing interventional techniques. • There is fair evidence with excessive bleeding, including epidural hematoma formation with interventional techniques when antithrombotic therapy is continued, the risk of higher thromboembolic phenomenon than epidural hematomas with discontinuation of antiplatelet therapy prior to interventional techniques and to continue phosphodiesterase inhibitors (dipyridamole, cilostazol, and Aggrenox). • There is limited evidence to discontinue antiplatelet therapy with platelet aggregation inhibitors to avoid bleeding and epidural hematomas and/or to continue antiplatelet therapy (clopidogrel, ticlopidine, prasugrel) during interventional techniques to avoid cerebrovascular and cardiovascular thromboembolic fatalities. • There is limited evidence in reference to newer antithrombotic agents dabigatran (Pradaxa) and rivaroxan (Xarelto) to discontinue to avoid bleeding and epidural hematomas and are continued during interventional techniques to avoid cerebrovascular and cardiovascular thromboembolic events. CONCLUSIONS: Evidence is fair to good for 62% of diagnostic and 52% of therapeutic interventions assessed. DISCLAIMER: The authors are solely responsible for the content of this article. No statement on this article should be construed as an official position of ASIPP. The guidelines do not represent "standard of care."

Assessment of bleeding risk of interventional techniques: a best evidence synthesis of practice patterns and perioperative management of anticoagulant and antithrombotic therapy.

BACKGROUND: Interventional pain management is a specialty that utilizes invasive procedures to diagnose and treat chronic pain. Patients undergoing these treatments may be receiving exogenous anticoagulants and antithrombotics. Even though the risk of major bleeding is very small, the consequences can be catastrophic. However, the role of antithrombotic therapy for primary and secondary prevention of cardiovascular disease to decrease the incidence of acute cerebral and cardiovascular events is also crucial. Overall, there is a paucity of literature on the subject of bleeding risk in interventional pain management along with practice patterns and perioperative management of anticoagulant and anti-thrombotic therapy. STUDY DESIGN: Best evidence synthesis. OBJECTIVE: To critically appraise and synthesize the literature with assessment of the bleeding risk of interventional techniques including practice patterns and perioperative management of anticoagulant and antithrombotic therapy. METHODS: The available literature on the bleeding risk of interventional techniques and practice patterns and perioperative management of anticoagulant and antithrombotic therapy was reviewed. Data sources included relevant literature identified through searches of PubMed and EMBASE from 1966 through December 2012 and manual searches of the bibliographies of known primary and review articles. RESULTS: There is good evidence for the risk of thromboembolic phenomenon in patients who discontinue antithrombotic therapy, spontaneous epidural hematomas occur with or without traumatic injury in patients with or without anticoagulant therapy associated with stressors such as chiropractic manipulation, diving, and anatomic abnormalities such as ankylosing spondylitis, and the lack of necessity of discontinuation of nonsteroidal anti-inflammatory drugs (NSAIDs), including low dose aspirin prior to performing interventional techniques. There is fair evidence that excessive bleeding, including epidural hematoma formation may occur with interventional techniques when antithrombotic therapy is continued, the risk of thromboembolic phenomenon is higher than the risk of epidural hematomas with discontinuation of antiplatelet therapy prior to interventional techniques, to continue phosphodiesterase inhibitors (dipyridamole [Persantine], cilostazol [Pletal], and Aggrenox [aspirin and dipyridamole]), and that anatomic conditions such as spondylosis, ankylosing spondylitis and spinal stenosis, and procedures involving the cervical spine; multiple attempts; and large bore needles increase the risk of epidural hematoma; and rapid assessment and surgical or nonsurgical intervention to manage patients with epidural hematoma can avoid permanent neurological complications. There is limited evidence to discontinue antiplatelet therapy with platelet aggregation inhibitors to avoid bleeding and epidural hematomas and/or to continue antiplatelet therapy clopidogrel (Plavix), ticlopidine (Ticlid), or prasugrel (Effient) during interventional techniques to avoid cerebrovascular and cardiovascular thromboembolic fatalities. There is limited evidence in reference to newer antithrombotic agents dabigatran (Pradaxa) and rivaroxaban (Xarelto) to discontinue to avoid bleeding and epidural hematomas during interventional techniques and to continue to avoid cerebrovascular and cardiovascular thromboembolic events. RECOMMENDATIONS: The recommendations derived from the comprehensive assessment of the literature and guidelines are to continue NSAIDs and low dose aspirin, and phosphodiesterase inhibitors (dipyridamole, cilostazol, Aggrenox) during interventional techniques. However, the recommendations for discontinuation of antiplatelet therapy with platelet aggregation inhibitors (clopidogrel, ticlopidine, prasugrel) is variable with clinical judgment to continue or discontinue based on the patient's condition, the planned procedure, risk factors, and desires, and the cardiologist's opinion. Low molecular weight heparin (LMWH) or unfractionated heparin may be discontinued 12 hours prior to performing interventional techniques. Warfarin should be discontinued or international normalized ratio (INR) be normalized to 1.4 or less for high risk procedures and 2 or less for low risk procedures based on risk factors. It is also recommended to discontinue Pradaxa for 24 hours for paravertebral interventional techniques in 2 to 4 days for epidural interventions in patients with normal renal function and for longer periods of time in patients with renal impairment, and to discontinue rivaroxaban for 24 hours prior to performing interventional techniques. LIMITATIONS:   The paucity of the literature. CONCLUSION: Based on the available literature including guidelines, the recommendations in patients with antithrombotic therapy for therapy prior to interventional techniques are provided.

An update of the appraisal of the accuracy of thoracic discography as a diagnostic test for chronic spinal pain.

BACKGROUND: Even though the prevalence of thoracic pain has been reported to be 13% of the general population and up to 22% of the population in interventional pain management settings, the role of thoracic discs as a cause of chronic thoracic and extrathoracic pain has not been well studied. The intervertebral discs, zygapophysial or facet joints, and other structures including the costovertebral and costotransverse joints have been identified as a source of thoracic pain. STUDY DESIGN: A systematic review of provocation thoracic discography. OBJECTIVE: To systematically assess and update the quality of clinical studies evaluating the diagnostic accuracy of provocation thoracic discography. METHODS: A systematic review of the literature was performed to assess the diagnostic accuracy of thoracic discography with respect to chronic, function limiting, thoracic or extrathoracic pain. The available literature on thoracic discography was reviewed. A methodological quality assessment of included studies was performed using Quality Appraisal of Reliability Studies (QAREL). The level of evidence was classified as good, fair, and limited (or poor) based on the quality of evidence developed by the U.S. Preventive Services Task Force (USPSTF). Data sources included relevant literature identified through searches of PubMed and EMBASE from 1966 to June 2012, and manual searches of the bibliographies of known primary and review articles. RESULTS: The evidence and clinical value of thoracic provocation discography is limited (poor) with a paucity of evidence, with only 2 studies meeting inclusion criteria. LIMITATIONS: The limitation of this study continues to be the paucity of literature. CONCLUSION: Based on the available evidence for this systematic review, due to limited evidence, thoracic provocation discography is rarely recommended for the diagnosis of discogenic pain in the thoracic spine, if conservative management has failed and facet joint pain has been excluded.

Utilization of interventional techniques in managing chronic pain in the Medicare population: analysis of growth patterns from 2000 to 2011.

BACKGROUND: Reports from the United States Government Accountability Office (GAO), the Institute of Medicine (IOM), the Medicare Payment Advisory Commission (MedPAC), and the Office of Inspector General (OIG) continue to express significant concern with the overall fiscal sustainability of Medicare and the exponential increase in costs for chronic pain management. STUDY DESIGN: The study is an analysis of the growth of interventional techniques in managing chronic pain in Medicare beneficiaries from 2000 to 2011. OBJECTIVE: To evaluate the use of all interventional techniques in chronic pain management. METHODS: The study was performed utilizing the Centers for Medicare and Medicaid Services (CMS) Physician Supplier Procedure Summary Master Data from 2000 to 2011. RESULTS: Interventional techniques for chronic pain have increased dramatically from 2000 to 2011. Overall, the increase of interventional pain management (IPM) procedures from 2000 to 2011 went up 228%, with 177% per 100,000 Medicare beneficiaries. The increases were highest for facet joint interventions and sacroiliac joint blocks with a total increase of 386% and 310% per 100,000 Medicare beneficiaries, followed by 168% and 127% for epidural and adhesiolysis procedures, 150% and 111% for other types of nerve blocks and finally, 28% and 8% increases for percutaneous disc procedures. The geometric average of annual increases was 9.7% overall with 13.7% for facet joint interventions and sacroiliac joint blocks and 7.7% for epidural and adhesiolysis procedures. LIMITATIONS: The limitations of this study included a lack of inclusion of Medicare participants in Medicare Advantage plans, as well as potential documentation, coding, and billing errors. CONCLUSION: Interventional techniques increased significantly in Medicare beneficiaries from 2000 to 2011. Overall, there was an increase of 177% in the utilization of IPM services per 100,000 Medicare beneficiaries, with an annual geometric average increase of 9.7%. The study also showed an exponential increase in facet joint interventions and sacroiliac joint blocks.

Assessment of infection control practices for interventional techniques: a best evidence synthesis of safe injection practices and use of single-dose medication vials.

BACKGROUND: It is universally accepted that transmission of bloodborne pathogens during health care procedures continues to occur because of the use of unsafe and improper injection, infusion, and medication administration practices by health care professionals in various clinical settings. This resulted in development of multiple guidelines based on case reports; however, these case reports are confounded by multiple factors without causal relationship to a single factor. Even then, single-dose vials used for multiple patients have been singled out and became the focus of infection control policies resulting in inordinate expenses for practices without improving patient safety. The cost of implementation of single dose vial policy in interventional pain management for drugs alone may cost $750 million, whereas with single use radional gloves may exceed $1 billion per year. STUDY DESIGN: Best evidence synthesis. OBJECTIVE: To critically appraise and synthesize the literature on infection control practices for interventional techniques, including safe injection and medication vial utilization. METHODS: The available literature on infection control practices was reviewed. Due to the nature of the studies involved, with the majority being case reports, and a few prospective evaluations, quality assessment and clinical relevance criteria were not applied. Data sources included relevant literature identified through searches of PubMed and EMBASE from 1966 through June 2012, literature from the Centers for Disease Control and Prevention (CDC), the U.S. Food and Drug Administration (FDA), and manual searches of the bibliographies of known primary and review articles. OUTCOME MEASURES: The primary outcome measure was correlating infection to a breach of standards in infection control practices. The secondary objective was to assess the contribution of single-dose vials independently for infection. RESULTS: A total of 60 reports met inclusion criteria, with 16 reports related to pain management and other procedures, of which 9 reports were attributed to issues related to interventional techniques. Based on an estimated 37 infections occurring during 200 million interventional techniques from 1997 through 2011, the rate of infection is speculated to be one infection for every 5 million interventional pain management procedures. However, if 10 times more infections are estimated, the infection rate appears to be one infection for every 500,000 interventional pain management procedures. The evidence is good for infection related to a breach of infection control practices. There is good evidence that contamination of multi-dose or single-dose vials can contribute to infection. There was poor evidence that the use of single-dose vials on multiple patients with appropriate infection control practices cause infection in interventional pain management. LIMITATIONS: The limitations of this comprehensive best evidence synthesis include the paucity of literature and dependence of governmental agencies on their literature without applying Institute of Medicine (IOM) criteria for guideline synthesis. CONCLUSION: There is good evidence that any breach of sterile practice may result in serious and life threatening infections. There is poor evidence for single-dose vials as a sole factor causing infections when used in multiple patients in interventional pain management settings.

The effectiveness of lumbar interlaminar epidural injections in managing chronic low back and lower extremity pain.

BACKGROUND: Intervertebral disc herniation, spinal stenosis, intervertebral disc degeneration without disc herniation, and post lumbar surgery syndrome are the most common diagnoses of chronic persistent low back and lower extremity symptoms, resulting in significant economic, societal, and health care impact. Epidural injections are one of the most commonly performed interventions in the United States in managing chronic low back pain. However the evidence is highly variable among different techniques utilized - namely interlaminar, caudal, and transforaminal - and for various conditions, namely - intervertebral disc herniation, spinal stenosis, and discogenic pain without disc herniation or radiculitis. Multiple systematic reviews conducted in the evaluation of the effectiveness of interlaminar epidural injections have been marred with controversy. Consequently, the debate continues with regards to the effectiveness, indications, and medical necessity of interlaminar epidural injections. STUDY DESIGN: A systematic review of lumbar interlaminar epidural injections with or without steroids. OBJECTIVE: To evaluate the effect of lumbar interlaminar epidural injections with or without steroids in managing various types of chronic low back and lower extremity pain emanating as a result of disc herniation or radiculitis, spinal stenosis, and chronic discogenic pain. METHODS: The available literature on lumbar interlaminar epidural injections with or without steroids in managing various types of chronic low back pain with or without lower extremity pain was reviewed. The quality assessment and clinical relevance criteria utilized were the Cochrane Musculoskeletal Review Group criteria as utilized for interventional techniques for randomized trials and the criteria developed by the Newcastle-Ottawa Scale criteria for observational studies. The level of evidence was classified as good, fair, or limited based on the quality of evidence developed by the U.S. Preventive Services Task Force (USPSTF). Data sources included relevant literature identified through searches of PubMed and EMBASE from 1966 to December 2011, and manual searches of the bibliographies of known primary and review articles. OUTCOME MEASURES: The primary outcome measure was pain relief (short-term relief = up to 6 months and long-term > 6 months). Secondary outcome measures were improvement in functional status, psychological status, return to work, and reduction in opioid intake. RESULTS: Overall, 82 lumbar interlaminar trials were identified. All non-randomized studies without fluoroscopy and randomized trials not meeting the inclusion criteria were excluded. Overall, 15 randomized trials and 11 non-randomized studies were included in the analysis. Analysis was derived mainly from fluoroscopically-guided randomized trials and non-randomized studies. The evidence is good for radiculitis secondary to disc herniation with local anesthetics and steroids, fair with local anesthetic only; whereas it is fair for radiculitis secondary to spinal stenosis with local anesthetic and steroids, and fair for axial pain without disc herniation with local anesthetic with or without steroids, with fluoroscopically-guided epidural injections. LIMITATIONS: The limitations of this study include that we were unable to perform meta-analysis for disc herniation, and the paucity of evidence for discogenic pain and spinal stenosis. Further, methodological criteria have been highly variable along with sample sizes. The studies were heterogenous. CONCLUSION: The evidence based on this systematic review is good for lumbar epidural injections under fluoroscopy for radiculitis secondary to disc herniation with local anesthetic and steroids, fair with local anesthetic only; whereas it is fair for radiculitis secondary to spinal stenosis with local anesthetic and steroids, and fair for axial pain without disc herniation with local anesthetic with or without steroids.

American Society of Interventional Pain Physicians (ASIPP) guidelines for responsible opioid prescribing in chronic non-cancer pain: Part I--evidence assessment.

BACKGROUND: Opioid abuse has continued to increase at an alarming rate since the 1990 s. As documented by different medical specialties, medical boards, advocacy groups, and the Drug Enforcement Administration, available evidence suggests a wide variance in chronic opioid therapy of 90 days or longer in chronic non-cancer pain. Part 1 describes evidence assessment. OBJECTIVES: The objectives of opioid guidelines as issued by the American Society of Interventional Pain Physicians (ASIPP) are to provide guidance for the use of opioids for the treatment of chronic non-cancer pain, to produce consistency in the application of an opioid philosophy among the many diverse groups involved, to improve the treatment of chronic non-cancer pain, and to reduce the incidence of abuse and drug diversion. The focus of these guidelines is to curtail the abuse of opioids without jeopardizing non-cancer pain management with opioids. RESULTS: 1) There is good evidence that non-medical use of opioids is extensive; one-third of chronic pain patients may not use prescribed opioids as prescribed or may abuse them, and illicit drug use is significantly higher in these patients. 2) There is good evidence that opioid prescriptions are increasing rapidly, as the majority of prescriptions are from non-pain physicians, many patients are on long-acting opioids, and many patients are provided with combinations of long-acting and short-acting opioids. 3) There is good evidence that the increased supply of opioids, use of high dose opioids, doctor shoppers, and patients with multiple comorbid factors contribute to the majority of the fatalities. 4) There is fair evidence that long-acting opioids and a combination of long-acting and short-acting opioids contribute to increasing fatalities and that even low-doses of 40 mg or 50 mg of daily morphine equivalent doses may be responsible for emergency room admissions with overdoses and deaths. 5) There is good evidence that approximately 60% of fatalities originate from opioids prescribed within the guidelines, with approximately 40% of fatalities occurring in 10% of drug abusers. 6) The short-term effectiveness of opioids is fair, whereas the long-term effectiveness of opioids is limited due to a lack of long-term (> 3 months) high quality studies, with fair evidence with no significant difference between long-acting and short-acting opioids. 7) Among the individual drugs, most opioids have fair evidence for short-term and limited evidence for long-term due to a lack of quality studies. 8) The evidence for the effectiveness and safety of chronic opioid therapy in the elderly for chronic non-cancer pain is fair for short-term and limited for long-term due to lack of high quality studies; limited in children and adolescents and patients with comorbid psychological disorders due to lack of quality studies; and the evidence is poor in pregnant women. 9) There is limited evidence for reliability and accuracy of screening tests for opioid abuse due to lack of high quality studies. 10) There is fair evidence to support the identification of patients who are non-compliant or abusing prescription drugs or illicit drugs through urine drug testing and prescription drug monitoring programs, both of which can reduce prescription drug abuse or doctor shopping. DISCLAIMER: The guidelines are based on the best available evidence and do not constitute inflexible treatment recommendations. Due to the changing body of evidence, this document is not intended to be a "standard of care."

American Society of Interventional Pain Physicians (ASIPP) guidelines for responsible opioid prescribing in chronic non-cancer pain: Part 2--guidance.

RESULTS: Part 2 of the guidelines on responsible opioid prescribing provides the following recommendations for initiating and maintaining chronic opioid therapy of 90 days or longer. 1. A) Comprehensive assessment and documentation is recommended before initiating opioid therapy, including documentation of comprehensive history, general medical condition, psychosocial history, psychiatric status, and substance use history. ( EVIDENCE: good) B) Despite limited evidence for reliability and accuracy, screening for opioid use is recommended, as it will identify opioid abusers and reduce opioid abuse. ( EVIDENCE: limited) C) Prescription monitoring programs must be implemented, as they provide data on patterns of prescription usage, reduce prescription drug abuse or doctor shopping. ( EVIDENCE: good to fair) D) Urine drug testing (UDT) must be implemented from initiation along with subsequent adherence monitoring to decrease prescription drug abuse or illicit drug use when patients are in chronic pain management therapy. ( EVIDENCE: good) 2. A) Establish appropriate physical diagnosis and psychological diagnosis if available prior to initiating opioid therapy. ( EVIDENCE: good) B) Caution must be exercised in ordering various imaging and other evaluations, interpretation and communication with the patient, to avoid increased fear, activity restriction, requests for increased opioids, and maladaptive behaviors. ( EVIDENCE: good) C) Stratify patients into one of the 3 risk categories - low, medium, or high risk. D) A pain management consultation, may assist non-pain physicians, if high-dose opioid therapy is utilized. ( EVIDENCE: fair) 3. Essential to establish medical necessity prior to initiation or maintenance of opioid therapy. ( EVIDENCE: good) 4. Establish treatment goals of opioid therapy with regard to pain relief and improvement in function. ( EVIDENCE: good) 5. A) Long-acting opioids in high doses are recommended only in specific circumstances with severe intractable pain that is not amenable to short-acting or moderate doses of long-acting opioids, as there is no significant difference between long-acting and short-acting opioids for their effectiveness or adverse effects. ( EVIDENCE: fair) B) The relative and absolute contraindications to opioid use in chronic non-cancer pain must be evaluated including respiratory instability, acute psychiatric instability, uncontrolled suicide risk, active or history of alcohol or substance abuse, confirmed allergy to opioid agents, coadministration of drugs capable of inducing life-limiting drug interaction, concomitant use of benzodiazepines, active diversion of controlled substances, and concomitant use of heavy doses of central nervous system depressants. ( EVIDENCE: fair to limited) 6. A robust agreement which is followed by all parties is essential in initiating and maintaining opioid therapy as such agreements reduce overuse, misuse, abuse, and diversion. ( EVIDENCE: fair) 7. A) Once medical necessity is established, opioid therapy may be initiated with low doses and short-acting drugs with appropriate monitoring to provide effective relief and avoid side effects. ( EVIDENCE: fair for short-term effectiveness, limited for long-term effectiveness) B) Up to 40 mg of morphine equivalent is considered as low dose, 41 to 90 mg of morphine equivalent as a moderate dose, and greater than 91 mg of morphine equivalence as high dose. ( EVIDENCE: fair) C) In reference to long-acting opioids, titration must be carried out with caution and overdose and misuse must be avoided. ( EVIDENCE: good) 8. A) Methadone is recommended for use in late stages after failure of other opioid therapy and only by clinicians with specific training in the risks and uses. ( EVIDENCE: limited) B) Monitoring recommendation for methadone prescription is that an electrocardiogram should be obtained prior to initiation, at 30 days and yearly thereafter. ( EVIDENCE: fair) 9. In order to reduce prescription drug abuse and doctor shopping, adherence monitoring by UDT and PMDPs provide evidence that is essential to the identification of those patients who are non-compliant or abusing prescription drugs or illicit drugs. ( EVIDENCE: fair) 10. Constipation must be closely monitored and a bowel regimen be initiated as soon as deemed necessary. ( EVIDENCE: good) 11. Chronic opioid therapy may be continued, with continuous adherence monitoring, in well-selected populations, in conjunction with or after failure of other modalities of treatments with improvement in physical and functional status and minimal adverse effects. ( EVIDENCE: fair). DISCLAIMER: The guidelines are based on the best available evidence and do not constitute inflexible treatment recommendations. Due to the changing body of evidence, this document is not intended to be a "standard of care."

Caudal epidural injections in the management of chronic low back pain: a systematic appraisal of the literature.

BACKGROUND: Epidural injections with local anesthetics and steroids are one of the most commonly used interventions in managing chronic low back pain and lower extremity pain of various causes. However, despite their extensive use, debate continues on their effectiveness due to the lack of well-designed, randomized, controlled studies to determine the effectiveness of epidural injections in general, and caudal epidural injections in particular. STUDY DESIGN: A systematic review of caudal epidural injections with or without steroids in managing chronic pain secondary to lumbar disc herniation or radiculitis, post lumbar laminectomy syndrome, spinal stenosis, and discogenic pain without disc herniation or radiculitis. OBJECTIVE: To evaluate the effect of caudal epidural injections with or without steroids in managing various types of chronic low back pain with or without lower extremity pain emanating as a result of disc herniation or radiculitis, post lumbar laminectomy syndrome, spinal stenosis, and chronic discogenic pain. METHODS: The available literature on caudal epidural injections with or without steroids in managing various types of chronic low back pain with or without lower extremity pain was reviewed. The quality assessment and clinical relevance criteria utilized were the Cochrane Musculoskeletal Review Group criteria as utilized for interventional techniques for randomized trials and the criteria developed by the Newcastle-Ottawa Scale criteria for fluoroscopic observational studies. The level of evidence was classified as good, fair, or poor based on the quality of evidence developed by the U.S. Preventive Services Task Force (USPSTF). Data sources included relevant literature identified through searches of PubMed and EMBASE from 1966 to December 2011, and manual searches of the bibliographies of known primary and review articles. OUTCOME MEASURES: The primary outcome measure was pain relief (short-term relief = up to 6 months and long-term > 6 months). Secondary outcome measures of improvement in functional status, psychological status, return to work, and reduction in opioid intake were utilized. RESULTS: For this systematic review, 73 studies were identified. Of these, 51 were excluded and a total of 16 studies met inclusion criteria for methodological quality assessment with 11 randomized trials and 5 non-randomized studies. For lumbar disc herniation, the evidence is good for short- and long-term relief of chronic pain secondary to disc herniation or radiculitis with local anesthetic and steroids and fair relief with local anesthetic only. In managing chronic axial or discogenic pain, spinal stenosis, and post surgery syndrome, the indicated evidence is fair. LIMITATIONS: The limitations of this study include the paucity of literature, specifically for chronic pain without disc herniation. CONCLUSION: There was good evidence for short- and long-term relief of chronic pain secondary to disc herniation or radiculitis with local anesthetic and steroids and fair relief with local anesthetic only. Further, this systematic review also provided indicated evidence of fair for caudal epidural injections in managing chronic axial or discogenic pain, spinal stenosis, and post surgery syndrome.

The impact of comparative effectiveness research on interventional pain management: evolution from Medicare Modernization Act to Patient Protection and Affordable Care Act and the Patient-Centered Outcomes Research Institute.

The Patient-Centered Outcomes Research Institute (PCORI) was established by the Affordable Care Act of 2010 to promote comparative effectiveness research (CER) to assist patients, clinicians, purchasers, and policy-makers in making informed health decisions by advancing the quality and relevance of evidence concerning the manner in which diseases, disorders, and other health conditions can effectively and appropriately be prevented, diagnosed, treated, monitored, and managed through research and evidence synthesis. The development of PCORI is vested in the Medicare Modernization Act (MMA) and the American Recovery and Reinvestment Act (ARRA). The framework of CER and PCORI describes multiple elements which are vested in all 3 regulations including stakeholder involvement, public participation, and open transparent decision-making process. Overall, PCORI is much more elaborate with significant involvement of stakeholders, transparency, public participation, and open decision-making. However, there are multiple issues concerning the operation of such agencies in the United States including the predecessor of Agency for Healthcare Research and Quality (AHRQ), the Agency for Healthcare Policy and Research (AHCPR), AHRQ Effectiveness Health Care programs, and others. The CER in the United States may be described at cross-roads or at the beginnings of a scientific era of CER and evidence-based medicine (EBM). However the United States suffers as other countries, including the United Kingdom with its National Health Services (NHS) and National Institute for Health and Clinical Excellence (NICE), with major misunderstandings of methodology, an inordinate focus on methodological assessment, lack of understanding of the study design (placebo versus active control), lack of involvement of clinicians, and misinterpretation of the evidence which continues to be disseminated. Consequently, PCORI and CER have been described as government-driven solutions without following the principles of EBM with an extensive focus on costs rather than quality. It also has been stated that the central planning which has been described for PCORI and CER, a term devised to be acceptable, will be used by third party payors to override the physician's best medical judgement and patient's best interest. Further, stakeholders in PCORI are not scientists, are not balanced, and will set an agenda with an ultimate problem of comparative effectiveness and PCORI that it is not based on medical science, but rather on political science and not even under congressional authority, leading to unprecedented negative changes to health care. Thus, PCORI is operating in an ad hoc manner that is incompatible with the principles of evidence-based practice.This manuscript describes the framework of PCORI, and the role of CER and its impact on interventional pain management.

Ambulatory surgery centers and interventional techniques: a look at long-term survival.

With health care expenditures skyrocketing, coupled with pervasive quality deficits, pressures to provide better and more proficient care continue to shape the landscape of the U.S. health care system. Payers, both federal and private, have laid out several initiatives designed to curtail costs, including value-based reimbursement programs, cost-shifting expenses to the consumer, reducing reimbursements for physicians, steering health care to more efficient settings, and finally affordable health care reform. Consequently, one of the major aspects in the expansion of health care for improving quality and reducing the costs is surgical services. Nearly 57 million outpatient procedures are performed annually in the United States, 14 million of which occur in elderly patients. Increasing use of these minor, yet common, procedures contributes to rising health care expenditures. Once exclusive within hospitals, more and more outpatient procedures are being performed in freestanding ambulatory surgery centers (ASCs), physician offices, visits to which have increased over 300% during the past decade. Concurrent with this growing demand, the number of ASCs has more than doubled since the 1990s, with more than 5,000 facilities currently in operation nationwide. Further, total surgical center ASC payments have increased from $1.2 billion in 1999 to $3.2 billion in 2009, a 167% increase. On the same lines, growth and expenditures for hospital outpatient department (HOPD) services and office procedures also have been evident at similar levels. Recent surveys have illustrated on overall annual growth per capita in Medicare allowed ASC services of pain management of 23%, with 27% growth seen in ASCs and 16% of the growth seen in HOPD. Further, the proportion of interventional pain management which was 4% of Medicare ASC spending in 2000 has increase to 10% in 2007. Thus, interventional pain management as an evolving specialty is one of the most commonly performed procedures in ASC settings apart from HOPDs and well-equipped offices. In June 1998, the Health Care Financing Administration (HCFA), proposed an ASC rule in which at least 60% of interventional procedures were eliminated from ASCs and the remaining 40% faced substantial cuts in payments. Following the publication of this rule, based on public comments and demand, Congress intervened and delayed implementation of the rule for several years. The Centers for Medicare and Medicaid Services (CMS) published its proposed outpatient prospective system for ASCs in 2006, setting ASC payments at 62% of HOPD payments. Following multiple changes, the rule was incorporated with a 4-year transition formula which ended in 2010, with full effect taking effect in 2011 with ASCs reimbursed at 57% of HOPD payments. Thus, the landscape of interventional pain management in ambulatory surgery centers has been constantly changing with declining reimbursements, issues of fraud and abuse, and ever-increasing regulations.

Patient Protection and Affordable Care Act of 2010: reforming the health care reform for the new decade.

The Patient Protection and Affordable Care Act (the ACA, for short) became law with President Obama's signature on March 23, 2010. It represents the most significant transformation of the American health care system since Medicare and Medicaid. It is argued that it will fundamentally change nearly every aspect of health care, from insurance to the final delivery of care. The length and complexity of the legislation and divisive and heated debates have led to massive confusion about the impact of ACA. It also became one of the centerpieces of 2010 congressional campaigns. Essentials of ACA include: 1) a mandate for individuals and businesses requiring as a matter of law that nearly every American have an approved level of health insurance or pay a penalty; 2) a system of federal subsidies to completely or partially pay for the now required health insurance for about 34 million Americans who are currently uninsured - subsidized through Medicaid and exchanges; 3) extensive new requirements on the health insurance industry; and 4) numerous regulations on the practice of medicine. The act is divided into 10 titles. It contains provisions that went into effect starting on June 21, 2010, with the majority of provisions going into effect in 2014 and later. The perceived major impact on practicing physicians in the ACA is related to growing regulatory authority with the Independent Payment Advisory Board (IPAB) and the Patient Centered Outcomes Research Institute (PCORI). In addition to these specifics is a growth of the regulatory regime in association with further discounts in physician reimbursement. With regards to cost controls and projections, many believe that the ACA does not fix the finances of our health care system - neither public nor private. It has been suggested that the Congressional Budget Office (CBO) and the administration have used creative accounting to arrive at an alleged deficit reduction; however, if everything is included appropriately and accounted for, we will be facing a significant increase in deficits rather than a reduction. When posed as a global question, polls suggest that public opinion continues to be against the health insurance reform. The newly elected Republican congress is poised to pass a bill aimed at repealing health care reform. However, advocates of the repeal of health care reform have been criticized for not providing a meaningful alternative approach. Those criticisms make clear that it is not sufficient to provide vague arguments against the ACA without addressing core issues embedded in health care reform. It is the opinion of the authors that while some parts of the ACA may be reformed, it is unlikely to be repealed. Indeed, the ACA already is growing roots. Consequently, it will be extremely difficult to repeal. In this manuscript, we look at reducing the regulatory burden on the public and providers and elimination of IPAB and PCORI. The major solution lies in controlling the drug and durable medical supply costs with appropriate negotiating capacity for Medicare, and consequently for other insurers.

Comprehensive evidence-based guidelines for interventional techniques in the management of chronic spinal pain.

BACKGROUND: Comprehensive, evidence-based guidelines for interventional techniques in the management of chronic spinal pain are described here to provide recommendations for clinicians. OBJECTIVE: To develop evidence-based clinical practice guidelines for interventional techniques in the diagnosis and treatment of chronic spinal pain. DESIGN: Systematic assessment of the literature. METHODS: Strength of evidence was assessed by the U.S. Preventive Services Task Force (USPSTF) criteria utilizing 5 levels of evidence ranging from Level I to III with 3 subcategories in Level II. OUTCOMES: Short-term pain relief was defined as relief lasting at least 6 months and long-term relief was defined as longer than 6 months, except for intradiscal therapies, mechanical disc decompression, spinal cord stimulation and intrathecal infusion systems, wherein up to one year relief was considered as short-term. RESULTS: The indicated evidence for accuracy of diagnostic facet joint nerve blocks is Level I or II-1 in the diagnosis of lumbar, thoracic, and cervical facet joint pain. The evidence for lumbar and cervical provocation discography and sacroiliac joint injections is Level II-2, whereas it is Level II-3 for thoracic provocation discography. The indicated evidence for therapeutic interventions is Level I for caudal epidural steroid injections in managing disc herniation or radiculitis, and discogenic pain without disc herniation or radiculitis. The evidence is Level I or II-1 for percutaneous adhesiolysis in management of pain secondary to post-lumbar surgery syndrome. The evidence is Level II-1 or II-2 for therapeutic cervical, thoracic, and lumbar facet joint nerve blocks; for caudal epidural injections in managing pain of post-lumbar surgery syndrome, and lumbar spinal stenosis, for cervical interlaminar epidural injections in managing cervical pain (Level II-1); for lumbar transforaminal epidural injections; and spinal cord stimulation for post-lumbar surgery syndrome. The indicated evidence for intradiscal electrothermal therapy (IDET), mechanical disc decompression with automated percutaneous lumbar discectomy (APLD), and percutaneous lumbar laser discectomy (PLDD) is Level II-2. LIMITATIONS: The limitations of these guidelines include a continued paucity of the literature, lack of updates, and conflicts in preparation of systematic reviews and guidelines by various organizations. CONCLUSION: The indicated evidence for diagnostic and therapeutic interventions is variable from Level I to III. These guidelines include the evaluation of evidence for diagnostic and therapeutic procedures in managing chronic spinal pain and recommendations for managing spinal pain. However, these guidelines do not constitute inflexible treatment recommendations. Further, these guidelines also do not represent "standard of care."

Systematic review of the effectiveness of cervical epidurals in the management of chronic neck pain.

BACKGROUND: Chronic neck pain is a common problem in the adult population with a typical 12-month prevalence of 30% to 50%, and 14% of the patients reporting grade II to IV neck pain with high pain intensity and disability that has a substantial impact on health care and society. Cervical epidural injections for managing chronic neck pain are one of the commonly performed interventions in the United States. However, the literature supporting cervical epidural steroids in managing chronic pain problems has been scant and no systematic review dedicated to the evaluation of cervical interlaminar epidurals has been performed in the past. STUDY DESIGN: A systematic review of cervical interlaminar epidural injections. OBJECTIVE: To evaluate the effect of cervical interlaminar epidural injections in managing various types of chronic neck and upper extremity pain emanating as a result of cervical spine pathology. METHODS: The available literature of cervical interlaminar epidural injections in managing chronic neck and upper extremity pain was reviewed. The quality assessment and clinical relevance criteria utilized were the Cochrane Musculoskeletal Review Group criteria as utilized for interventional techniques for randomized trials and the criteria developed by the Agency for Healthcare Research and Quality (AHRQ) criteria for observational studies. The level of evidence was classified as Level I, II, or III based on the quality of evidence developed by the U.S. Preventive Services Task Force (USPSTF) for therapeutic interventions. Data sources included relevant literature of the English language identified through searches of PubMed and EMBASE from 1966 to November 2008, and manual searches of bibliographies of known primary and review articles. OUTCOME MEASURES: The primary outcome measure was pain relief (short-term relief = up to 6 months and long-term > 6 months). Secondary outcome measures were improvement in functional status, psychological status, return to work, and reduction in opioid intake. RESULTS: The indicated evidence is Level II-1 in managing chronic neck and upper extremity pain with 1C/strong recommendation. LIMITATIONS: The limitations of this systematic review include the paucity of literature and lack of randomized trials performed under fluoroscopy. CONCLUSION: The results of this systematic evaluation of cervical interlaminar epidural injection showed significant effect in relieving chronic intractable pain of cervical origin and also providing long-term relief with an indicated evidence level of Level II-1.

Lumbar interlaminar epidural injections in managing chronic low back and lower extremity pain: a systematic review.

BACKGROUND: Low back pain with or without lower extremity pain is the most common problem among chronic pain disorders with significant economic, societal, and health impact. Epidural injections are one of the most commonly performed interventions in the United States in managing chronic low back pain. However the evidence is highly variable among different techniques utilized - namely interlaminar, caudal, transforaminal - and for various conditions, namely - intervertebral disc herniation, spinal stenosis, and discogenic pain without disc herniation or radiculitis. STUDY DESIGN: A systematic review of lumbar interlaminar epidural injections with or without steroids. OBJECTIVE: To evaluate the effect of lumbar interlaminar epidural injections with or without steroids in managing various types of chronic low back and lower extremity pain emanating as a result of disc herniation or radiculitis, spinal stenosis, and chronic discogenic pain. METHODS: Review of the literature and methodologic quality assessment were performed according to the Cochrane Musculoskeletal Review Group Criteria as utilized for interventional techniques for randomized trials and the Agency for Healthcare Research and Quality (AHRQ) criteria for observational studies. The level of evidence was classified as Level I, II, or III based on the quality of evidence developed by the U.S. Preventive Services Task Force (USPSTF) for therapeutic interventions. Data sources included relevant literature of the English language identified through searches of PubMed and EMBASE from 1966 to November 2008, and manual searches of bibliographies of known primary and review articles. Results of analysis were performed for multiple conditions separately. OUTCOME MEASURES: The primary outcome measure was pain relief (short-term relief = up to 6 months and long-term > 6 months). Secondary outcome measures were improvement in functional status, psychological status, return to work, and reduction in opioid intake. RESULTS: The available literature included only blind epidural injections without fluoroscopy. The indicated evidence is positive (Level II-2) for short-term relief of pain of disc herniation or radiculitis utilizing blind interlaminar epidural steroid injections with lacking of evidence with Level III for long-term relief for disc herniation and radiculitis. The evidence is lacking with Level III for short and long-term relief for spinal stenosis and discogenic pain without radiculitis or disc herniation utilizing blind epidural injections. LIMITATIONS: The limitations of this study include paucity of literature, lack of quality evidence, lack of fluoroscopic procedures, and lack of applicable evidence in contemporary interventional pain management practices. CONCLUSION: The evidence based on this systematic review is limited for blind interlaminar epidurals in managing all types of pain except for short-term relief of pain secondary to disc herniation and radiculitis. This evidence does not represent contemporary interventional pain management practices and also the evidence may not be extrapolated to fluoroscopically directed lumbar interlaminar epidural injections.