Efficacy and safety of acupuncture treatment as an adjunctive therapy after knee replacement: Single-center, pragmatic, randomized, assessor blinded, pilot study.

INTRODUCTION: Total knee replacement (TKR) is a surgical procedure that is being increasingly performed as a result of population aging and the increased average human life expectancy in South Korea. Consistent with the growing number of TKR procedures, the number of patients seeking acupuncture for relief from adverse effects, effective pain management, and the enhancement of rehabilitative therapy effects and bodily function after TKR has also been increasing. Thus, an objective examination of the evidence regarding the safety and efficacy of acupuncture treatments is essential. The aim of this study is to verify the hypothesis that the concurrent use of acupuncture treatment and usual care after TKR is more effective, safe, and cost-effective for the relief of TKR symptoms than usual care therapy alone. METHODS/DESIGN: This is an open-label, parallel, assessor-blinded randomized controlled trial that includes 50 patients with TKR. After screening the patients and receiving informed consent, the patients are divided into two groups (usual care + acupuncture group and usual care group); the patients will then undergo TKR surgery and will be hospitalized for 2 weeks. The patients will receive a total of 8 acupuncture treatments over 2 weeks after surgery and will be followed up at 3, 4, and 12 weeks after the end of the intervention. The primary outcome is assessed using the Korean version of the Western Ontario and McMaster Universities Arthritis Index (K-WOMAC), and the secondary outcome is measured using the Numerical Rating Scale (NRS), Risk of Fall, and Range of Motion (ROM). Moreover, the cost per quality-adjusted life years (QALYs) is adopted as a primary economic outcome for economic evaluation, and the cost per NRS is adopted as a secondary economic outcome. ETHICS AND DISSEMINATION: This trial has received complete ethical approval from the Ethics Committee of Catholic Kwandong University International St. Mary's Hospital (IS17ENSS0063). We intend to submit the results to a peer-reviewed journal and/or conferences. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03633097.

Prevalence and Cost Analysis of Chronic Pain After Hernia Repair: A Potential Alternative Approach With Neurostimulation.

OBJECTIVES: Chronic pain (CP) affects a significant number of patients following hernia repair, ranging from 11 to 54% in the literature. The aim of this study was to assess the prevalence, overall costs, and health care utilization associated with CP after hernia repair. MATERIALS AND METHODS: A retrospective longitudinal study was performed using the Truven MarketScan® data base to identify patients who develop chronic neuropathic posthernia repair pain from 2001 to 2012. Patients were grouped into CP and No Chronic Pain (No CP) cohorts. Patients were excluded if they 1) were under 18 years of age; 2) had a previous pain diagnosis; 3) had CP diagnosed <90 days after the index hernia repair; 4) had less than one year of follow-up; or 5) had less than one-year baseline record before hernia repair. Patients were grouped into the CP cohort if their CP diagnosis was made within the two years following index hernia repair. Total, outpatient, and pain prescription costs were collected in the period of five years prehernia to nine years posthernia repair. A longitudinal multivariate analysis was used to model the effects of chronic neuropathic posthernia repair pain on total inpatient/outpatient and pain prescription costs. RESULTS: We identified 76,173 patients who underwent hernia repair and met inclusion criteria (CP: n = 14,919, No CP: n = 61,254). There was a trend for increased total inpatient/outpatient and pain prescription costs one-year posthernia repair, when compared to baseline costs for both cohorts. In both cohorts, total inpatient/outpatient costs remained elevated from baseline through nine years posthernia repair, with the CP cohort experiencing significantly higher cumulative median costs (CP: $51,334, No CP: $37,388). The CP diagnosis year was associated with a 1.75-fold increase (p < 0.001) in total inpatient/outpatient costs and a 2.26-fold increase (p < 0.001) in pain prescription costs versus all other years. In the longitudinal analysis, the CP cohort had a 1.14-fold increase (p < 0.001) in total inpatient/outpatient costs and 2.00-fold increase (p < 0.001) in pain prescription costs. CONCLUSIONS: Our study demonstrates the prevalence of CP after hernia surgery to be nearly 20%, with significantly increased costs and healthcare resource utilization. While current treatment paradigms are effective for many, there remains a large number of patients that could benefit from an overall approach that includes nonopioid treatments, such as potentially incorporating neurostimulation, for CP that presents posthernia repair.

A multi-center, randomized controlled clinical trial, cost-effectiveness and qualitative research of electroacupuncture with usual care for patients with non-acute pain after back surgery: study protocol for a randomized controlled trial.

BACKGROUND: Although pain after back surgery is known to be difficult to control, various treatment options are available to patients and physicians. A protocol for a confirmatory randomized controlled trial (RCT) on pain and function after back surgery was designed based on the results of a pilot trial. The aim of this study is to compare the effectiveness and safety of electroacupuncture (EA) with usual care (UC) versus UC alone on pain control and functional improvement after back surgery. METHODS/DESIGN: This study is a multi-center, randomized, assessor-blinded trial with an active control conducted in conjunction with a cost-effectiveness analysis and qualitative research. Participants with non-acute low back pain with or without leg pain after back surgery who have a Visual Analogue Scale (VAS) pain intensity score ≥ 50 mm will be randomly assigned to either the EA with UC group (n = 54) or the UC group (n = 54). Following randomization, participants in both groups will receive the same UC treatment twice a week for a four-week treatment period. Participants assigned to the EA with UC group will additionally receive EA twice a week for the same four-week period. The primary outcome measure will be assessed using a VAS pain intensity score for low back pain. The secondary outcomes will include the Oswestry Disability Index, EuroQol 5-Dimension score, and drug intake. The primary and secondary outcomes will be measured at one, four, and eight weeks post randomization. DISCUSSION: The results of this study will provide evidence of the effectiveness and cost-effectiveness of EA in managing postoperative pain following back surgery. In addition, the qualitative research results will help improve the quality of integrative medical interventions. TRIAL REGISTRATION: Clinical Research Information Service (CRIS), Republic of Korea, KCT0001939 . Registered on 8 June 2016.

Economic assessment of postoperative pain control strategies for treatment of adult patients with cancer.

OBJECTIVE: The authors performed an economic assessment of opioids currently being used for control of postoperative pain relating to the surgical treatment of cancer (fentanyl and sufentanil) within the Brazilian Unified Health System (SUS, in the Portuguese acronym). METHOD: The assessment was based on the perspective of the government, in order to collaborate with the promotion of effectiveness in public policies of health, and to optimize the allocation of public resources into health. A cost-effectiveness analysis was performed using data collected from the Brazilian Unified Health System and information from literature review, in order to build a decision tree on the alternatives for control of postoperative pain related to cancer treatment among adult patients. The outcomes considered were: effectiveness of postoperative analgesia and occurrence of nausea and vomit in the 48 hour period after surgery, and additional 24-hour cycles in patient follow-up. A univariate sensitivity analysis was conducted in order to verify robustness of the model estimated. RESULTS: Literature review showed a limited number of studies directly comparing fentanyl and sufentanil for control of postoperative pain. The adoption of sufentanil (cost = U$ 25.72 / outcome = 1.6 VAS points) was dominant in relation to the use of fentanyl (cost = U$ 32.58 / outcome = 2.6 VAS points). The estimated model showed robustness in relation to changes in the parameters analyzed. CONCLUSION: Sufentanil presented higher cost-effectiveness ratio in relation to fentanyl for control of postoperative pain in surgeries related to cancer treatment among adult patients in the Brazilian Unified Health System.

Medical clowns reduce pre-operative anxiety, post-operative pain and medical costs in children undergoing outpatient penile surgery: A randomised controlled trial.

AIM: The aim of this paper is to investigate prospectively the potential benefits of the participation of the medical clowns in the outpatient paediatric penile surgery programme. METHODS: Eighty children undergoing meatotomy, age 2 to 16 years, were randomised into two groups (40 each). In the first group, the medical clown was an integral part of the medical team, and in the second group, the treatment was given without participation of the medical clown. The following parameters were measured: the level of pre-operative anxiety, the level of the post-operative pain, the amount of pain medication use in the first 24 h after surgery and the time needed to return to normal activities. The operating room time and hospital costs were calculated. RESULTS: The patients from the first group demonstrated a lower pre-operative anxiety index upon (P = 0.0319) and after surgery (P = 0.0042), required less induction time for anaesthesia (P < 0.001), spent overall less time in the operating room (P < 0.0001) and required less time to recover from the surgery and to be discharged (P = 0.0172). The overall OR time and post-operative unit care savings of 20 and 155 min, respectively, led to the cost savings of $467. CONCLUSION: Our data demonstrated that the use of the medical clown functioning as an integral part of the operating team reduces children pre-operative anxiety and leads to a shortening of the overall time in the hospital thereby reducing the overall medical cost justifying the participation of medical clown as an integral part of the health team in a paediatric urology outpatient surgical unit.

Electroacupuncture for postoperative pain and gastrointestinal motility after laparoscopic appendectomy (AcuLap): study protocol for a randomized controlled trial.

BACKGROUND: Acupuncture is a widely serviced complementary medicine. Although acupuncture is suggested for managing postoperative ileus and pain, supporting evidence is weak. The AcuLap trial is designed to provide high-level evidence regarding whether or not electroacupuncture is effective in promoting gastrointestinal motility and controlling pain after laparoscopic surgery. METHODS/DESIGN: This study is a prospective randomized controlled trial with a three-arm, parallel-group structure evaluating the efficacy of electroacupuncture for gastrointestinal motility and postoperative pain after laparoscopic appendectomy. Patients with appendicitis undergoing laparoscopic surgery are included and randomized into three groups: 1) electroacupuncture group, 2) sham acupuncture group, and 3) control group. Patients receive 1) acupuncture with electrostimulation or 2) fake electroacupuncture with sham device twice a day or 3) no acupuncture after laparoscopic appendectomy. The primary outcome is time to first passing flatus after operation. Secondary outcomes include postoperative pain, analgesics, nausea/vomiting, bowel motility, time to tolerable diet, complications, hospital stay, readmission rates, time to recovery, quality of life, medical costs, and protocol failure rate. Patients and hospital staff (physicians and nurses) are blinded to which group the patient is assigned, electroacupuncture or sham acupuncture. Data analysis personnel are blinded to group assignment among all three groups. Estimated sample size to detect a minimum difference of time to first flatus with 80 % power, 5 % significance, and 10 % drop rate is 29 × 3 groups = 87 patients. Analysis will be performed according to the intention-to-treat principle. DISCUSSION: The AcuLap trial will provide evidence on the merits and/or demerits of electroacupuncture for bowel motility recovery and pain relief after laparoscopic appendectomy. TRIAL REGISTRATION: The trial was registered in Clinical Research Information Service (CRiS), Republic of Korea ( KCT0001486 ) on 14 May 2015.

Assessing the effectiveness and cost effectiveness of subcutaneous nerve stimulation in patients with predominant back pain due to failed back surgery syndrome (SubQStim study): study protocol for a multicenter randomized controlled trial.

BACKGROUND: Chronic radicular pain can be effectively treated with spinal cord stimulation, but this therapy is not always sufficient for chronic back pain. Subcutaneous nerve stimulation (SQS) refers to the placement of percutaneous leads in the subcutaneous tissue within the area of pain. Case series data show that failed back surgery syndrome (FBSS) patients experience clinically important levels of pain relief following SQS and may also reduce their levels of analgesic therapy and experience functional well-being. However, to date, there is no randomized controlled trial evidence to support the use of SQS in FBSS. METHODS/DESIGN: The SubQStim study is a multicenter randomized controlled trial comparing SQS plus optimized medical management ('SQS arm') versus optimized medical management alone ('OMM arm') in patients with predominant back pain due to FBSS. Up to 400 patients will be recruited from approximately 33 centers in Europe and Australia and will be randomized 1:1 to the SQS or OMM arms. After 9 months, patients who fail to reach the primary outcome will be allowed to switch treatments. Patients will be evaluated at baseline (prior to randomization) and at 1, 3, 6, 9, 12, 18, 24, and 36 months after randomization. The primary outcome is the proportion of patients at 9 months with a ≥50% reduction in back pain intensity compared to baseline. The secondary outcomes are: back and leg pain intensity score, functional disability, health-related quality of life, patient satisfaction, patient global impression of change, healthcare resource utilization/costs, cost-effectiveness analysis and adverse events. Outcomes arms will be compared between SQS and OMM arms at all evaluation points up to and including 9 months. After the 9-month assessment visit, the main analytic focus will be to compare within patient changes in outcomes relative to baseline. DISCUSSION: The SubQStim trial began patient recruitment in November 2012. Recruitment is expected to close in late 2014. TRIAL REGISTRATION: ClinicalTrials.gov NCT01711619.

Does a perioperative belladonna and opium suppository improve postoperative pain following robotic assisted laparoscopic radical prostatectomy? Results of a single institution randomized study.

INTRODUCTION: Robotic assisted laparoscopic radical prostatectomy (RALP) is a common treatment for localized prostate cancer. Despite a primary advantage of improved postoperative pain, patients undergoing RALP still experience discomfort. Belladonna, containing the muscarinic receptor antagonists atropine and scopolamine, in combination with opium as a rectal suppository (B & O) may improve post-RALP pain. This study evaluates whether a single preoperative B & O results in decreased postoperative patient-reported pain and analgesic requirements. MATERIALS AND METHODS: Patients undergoing RALP at Virginia Mason Medical Center between November 2008 and July 2009 were offered the opportunity to enter a randomized, double-blind, placebo-controlled trial. Exclusion criteria included: glaucoma, bronchial asthma, convulsive disorders, chronic pain, chronic use of analgesics, or a history of alcohol or opioid dependency. Surgeons were blinded to suppository placement which was administered after induction of anesthesia. All patients underwent a standardized anesthesia regimen. Postoperative pain was assessed by a visual analog scale (VAS) and postoperative narcotic use was calculated in intravenous morphine equivalents. RESULTS: Ninety-nine patients were included in the analysis. The B & O and control groups were not significantly different in terms of age, body mass index, operative time, nerve sparing status or prostatic volume. Postoperative pain was significantly improved during the first two postoperative hours in the B & O group. Similarly, 24-hour morphine consumption was significantly lower in patients who received a B & O. No adverse effects secondary to suppository placement were identified. CONCLUSION: Preoperative administration of B & O suppository results in significantly decreased postoperative pain and 24-hour morphine consumption in patients undergoing RALP.

[Acupuncture: basics, practice, and evidence]. / Akupunktur: grundlagen, praxis und evidenz.

Acupuncture, which originated with traditional Chinese medicine, has been increasingly used in Western medicine over the last three decades. A huge body of scientific literature reports the physiological and clinical effects of acupuncture. In Germany, about 30,000 physicians apply acupuncture at least occasionally, and German health insurances reimburse acupuncture treatment for chronic low back pain and osteoarthritis of the knee. This overview discusses the most important historical, theoretical, practical, and scientific aspects of acupuncture in general, with a special look at anaesthesia. Regarding anaesthesia, supportive acupuncture treatment is performed for postoperative pain, anxiolysis, and postoperative nausea and vomiting, based on promising results of rigorous randomised trials. However, many unresolved questions remain, such as regarding specificity of concepts, indications, and optimum dose.

[Drugs for postoperative analgesia: routine and new aspects: Part 2: opioids, ketamine and gabapentinoids]. / Medikamente zur postoperativen schmerztherapie: bewährtes und neues : Teil 2: Opioide, ketamin und gabapentinoide.

In part 1 of this review, perioperative aspects of the use of non-opioids (acetaminophene, dipyrone, traditional NSAR, coxibs) were discussed. In part 2 the perioperative aspects of opioids (weak opioids: tramadol, tilidine with naloxone, strong opioids: morphine, piritramide, oxycodone, hydromorphone, fentanyl, methadone, buprenorphine) and coanalgesics (gabapentinoids; ketamine) will now be presented. The main aim of the review is to describe the use, risks and cost of some substances to facilitate the differential indication. New aspects concerning the use of gabapentinoids and ketamine are discussed.

Efficacy of oral rofecoxib versus intravenous ketoprofen as an adjuvant to PCA morphine after urologic surgery.

BACKGROUND: Adjunctive use of nonsteroidal anti-inflammatory drugs has become increasingly popular in the perioperative period because of their opioid-sparing effects. This randomized, controlled, double-dummy study was designed to evaluate the cost-effectiveness of using oral rofecoxib as an alternative to intravenous ketoprofen for pain management in patients undergoing urologic surgery. METHODS: Seventy patients were randomly assigned to receive either a placebo (Control) or rofecoxib 50 mg po (Rofecoxib) 1 h prior to surgery. After a standardized spinal anesthetic, patients in the Control group received ketoprofen 100 mg IV q 8 h for 24 h, while the Rofecoxib group received an equivolume of saline at 8-h intervals for 24 h. Both groups were allowed to self-administer morphine (1 mg IV boluses) using a PCA delivery system. The need for 'rescue' analgesic medication, as well as pain scores [using an 11-point verbal rating scale (VRS) (0 = none to 10-severe)], were recorded at 1, 2, 6, 12, and 24-h intervals after surgery. In addition, the incidences of side-effects were recorded at the end of the study period. RESULTS: Total amount of morphine required in the initial 24-h postoperative period was nonsignificantly reduced in the Rofecoxib group (29 +/- 2 vs. 37 +/- 4 mg). More importantly, the percentage of patients reporting moderate-to-severe pain (VRS score > or =4) during the study period was lower in the Rofecoxib group (12 vs. 22%, P < 0.05). The daily cost of rofecoxib (USD 1.14 for 50-mg dose) was also significantly less than ketoprofen (USD 3.06 for three 100-mg doses). CONCLUSION: Premedication with oral rofecoxib (50 mg) is a cost-effective alternative to the parenteral nonselective NSAID, ketoprofen (100 mg q 8 h), when used as an adjuvant to PCA morphine for pain management after urologic surgery.

The burden of acute postoperative pain and the potential role of the COX-2-specific inhibitors.

Pain has been recognized as a problem of global proportions, and postoperative pain is one of the most common types of pain. Postoperative pain is acute and, although it is preventable and/or treatable, it is often undertreated. Lack of appropriate analgesic management has significant impact on clinical and economic outcomes. Negative clinical outcomes of inadequately managed acute postoperative pain include extended hospitalization, compromised prognosis, higher morbidity and mortality, and the development of a chronic pain state as a result of neuronal plasticity. Although estimating the economic burden of postoperative pain is difficult, this burden is considerable and results from direct costs due to excess health-care resource use, as well as indirect costs due to reduced patient functionality and productivity. These latter factors also have a significant adverse impact on patients' quality of life and may be associated with the development of depression and anxiety. Thus, improved clinical outcomes are dependent not only on the availability of effective drugs but also on their appropriate utilization. A multimodal approach incorporating different drugs and techniques is effective in reducing postoperative pain but is limited by the currently available therapies. The efficacy of opioids is well established, but there are concerns about dependency, respiratory depression and side-effects, which patients often find intolerable. Non-steroidal anti-inflammatory drugs (NSAIDs) are effective as adjunctive medication in a multimodal regimen but are associated with side-effects, such as platelet dysfunction and renal and gastrointestinal toxicity, that have special clinical significance in patients undergoing surgical procedures. Cyclooxygenase-2-specific inhibitors such as celecoxib, rofecoxib and valdecoxib, were developed to provide the efficacy of non-specific NSAIDs while limiting associated toxicity. These agents have demonstrated analgesic efficacy and an opioid-sparing effect in a variety of surgical procedures, suggesting their value as an alternative to non-specific NSAIDs. Further studies are needed to determine the impact of these drugs on clinical and economic outcomes when used in a programme of postsurgical pain management.

[Postoperative pain management. Aims and organization of a strategy for postoperative acute pain therapy]. / La gestione del dolore postoperatorio. Obiettivi, identificazione e organizzazione delle procedure di sviluppo di un programma di terapia del dolore acuto postoperatorio.

The Health Services, not only the Italian one, is under pressure because of request for improving treatment quality and the financial need for reorganization and cost-saving. It's required a rationalization of intervention, together with a careful choice of the best and cheapest techniques and the demonstration of their efficacy. The anaesthesia service activity, in a period of cost rationalization and funds restriction should be aimed to appropriate outcome measures corrected by both patient's risk factors and surgical-anaesthesiological case-mix. The development of a complete strategy for surgical pain management might run into two phases. The first phase, internal and mono-specialistic, should develop like the creation of an Acute Pain Team. The main processes are: focusing the problem (charge of the care), training, information, teaching methodology (timing, methods, drugs, techniques, etc.) and the audit (before and after changes). The main aims are the evaluation of the level of analgesia and pain relief or patient's satisfaction which are partial endpoints useful to demonstrate the improvement and the efficacy of the new pain management strategies. The second phase, multidisciplinary, is directed toward the creation of a Postoperative Evaluation Team. The main objective is to set up a collaborative clinical group able to identify the criteria for quality, efficacy and safety. The major purpose is the evaluation of major outcome measures: surgical outcome, morbidity, mortality and length of hospitalization. The improvement in the quality of postoperative pain treatment goes through a better organization and a progressive increase of the already available therapy. The achievement of the result and the quality projects depend on the interaction among staff members with different behaviours and settings. Internal teaching and training, continuous education for doctors and nurses, and external information, marketing and improvement of attractive capability of Institution, are the procedures of a growing integrated program for postoperative pain treatment. The organizational processes should interact effectively with a plan of education, updating, revision and information in a definite development timing. It should be emphasized a collaborative, interdisciplinary approach to pain control, assessment and treatment, including all the members of the health care team, with an input from the patient and a protective collaboration from the Institution. The development of a postoperative care team must be considered as part of the largest project for "a Painfree Hospital". It represents a keystone of a Institutional Quality Assurance Plan for health care providers, patients (customs) and Institution.