Brief Assessment of Patient Phenotype to Explain Variability in Postsurgical Pain and Opioid Consumption after Cesarean Delivery: Performance of a Novel Brief Questionnaire Compared to Long Questionnaires.

BACKGROUND: Understanding factors that explain why some women experience greater postoperative pain and consume more opioids after cesarean delivery is crucial to building an evidence base for personalized prevention. Comprehensive psychosocial assessment with validated questionnaires in the preoperative period can be time-consuming. A three-item questionnaire has shown promise as a simpler tool to be integrated into clinical practice, but its brevity may limit the ability to explain heterogeneity in psychosocial pain modulators among individuals. This study compared the explanatory ability of three models: (1) the 3-item questionnaire, (2) a 58-item questionnaire (long) including validated questionnaires (e.g., Brief Pain Inventory, Patient Reported Outcome Measurement Information System [PROMIS]) plus the 3-item questionnaire, and (3) a novel 19-item questionnaire (brief) assessing several psychosocial factors plus the 3-item questionnaire. Additionally, this study explored the utility of adding a pragmatic quantitative sensory test to models. METHODS: In this prospective, observational study, 545 women undergoing cesarean delivery completed questionnaires presurgery. Pain during local anesthetic skin wheal before spinal placement served as a pragmatic quantitative sensory test. Postoperatively, pain and opioid consumption were assessed. Linear regression analysis assessed model fit and the association of model items with pain and opioid consumption during the 48 h after surgery. RESULTS: A modest amount of variability was explained by each of the three models for postoperative pain and opioid consumption. Both the brief and long questionnaire models performed better than the three-item questionnaire but were themselves statistically indistinguishable. Items that were independently associated with pain and opioid consumption included anticipated postsurgical pain medication requirement, surgical anxiety, poor sleep, pre-existing pain, and catastrophic thinking about pain. The quantitative sensory test was itself independently associated with pain across models but only modestly improved models for postoperative pain. CONCLUSIONS: The brief questionnaire may be more clinically feasible than longer validated questionnaires, while still performing better and integrating a more comprehensive psychosocial assessment than the three-item questionnaire.

Procedure-specific acute pain trajectory after elective total hip arthroplasty: systematic review and data synthesis.

BACKGROUND: For most procedures, there is insufficient evidence to guide clinicians in the optimal timing of advanced analgesic methods, which should be based on the expected time course of acute postoperative pain severity and aimed at time points where basic analgesia has proven insufficient. METHODS: We conducted a systematic search of the literature of analgesic trials for total hip arthroplasty (THA), extracting and pooling pain scores across studies, weighted for study size. Patients were grouped according to basic anaesthetic method used (general, spinal), and adjuvant analgesic interventions such as nerve blocks, local infiltration analgesia, and multimodal analgesia. Special consideration was given to high-risk populations such as chronic pain or opioid-dependent patients. RESULTS: We identified and analysed 71 trials with 5973 patients and constructed pain trajectories from the available pain scores. In most patients undergoing THA under general anaesthesia on a basic analgesic regimen, postoperative acute pain recedes to a mild level (<4/10) by 4 h after surgery. We note substantial variability in pain intensity even in patients subjected to similar analgesic regimens. Chronic pain or opioid-dependent patients were most often actively excluded from studies, and never analysed separately. CONCLUSIONS: We have demonstrated that it is feasible to construct procedure-specific pain curves to guide clinicians on the timing of advanced analgesic measures. Acute intense postoperative pain after THA should have resolved by 4-6 h after surgery in most patients. However, there is a substantial gap in knowledge on the management of patients with chronic pain and opioid-dependent patients.

A Contemporary Medicolegal Analysis of Outpatient Medication Management in Chronic Pain.

BACKGROUND: Opioids are frequently used in chronic pain management but are associated with significant morbidity and mortality in some patient populations. An important avenue for identifying complications-including serious or rare complications-is the study of closed malpractice claims. The present study is intended to complement the existing closed claims literature by drawing on claims from a more recent timeframe through a partnership with a large malpractice carrier, the Controlled Risk Insurance Company (CRICO). The goal of this study was to identify patient medical comorbidities and aberrant drug behaviors, as well as prescriber practices associated with patient injury and malpractice claims. Another objective was to identify claims most likely to result in payments and use this information to propose a strategy for reducing medicolegal risk. METHODS: The CRICO Strategies Comparative Benchmarking System is a database of claims drawing from >350,000 malpractice claims from Harvard-affiliated institutions and >400 other academic and community institutions across the United States. This database was queried for closed claims from January 1, 2009, to December 31, 2013, and identified 37 cases concerning noninterventional, outpatient chronic pain management. Each file consisted of a narrative summary, including expert witness testimony, as well as coded fields for patient demographics, medical comorbidities, the alleged damaging event, the alleged injurious outcome, the total financial amount incurred, and more. We performed an analysis using these claim files. RESULTS: The mean patient age was 43.5 years, with men representing 59.5% of cases. Payments were made in 27% of cases, with a median payment of $72,500 and a range of $7500-$687,500. The majority of cases related to degenerative joint disease of the spine and failed back surgery syndrome; no patients in this series received treatment of malignant pain. Approximately half (49%) of cases involved a patient death. The use of long-acting opioids and medical conditions affecting the cardiac and pulmonary systems were more closely associated with death than with other outcomes. The nonpain medical conditions present in this analysis included obesity, obstructive sleep apnea, chronic obstructive pulmonary disease, hypertension, and coronary artery disease. Other claims ranged from alleged addiction to opioids from improper prescribing to alleged abandonment with withdrawal of care. The CRICO analysis suggested that patient behavior contributed to over half of these claims, whereas deficits in clinical judgment contributed to approximately 40% of the claims filed. CONCLUSIONS: Claims related to outpatient medication management in pain medicine are multifactorial, stemming from deficits in clinical judgment by physicians, noncooperation in care by patients, and poor clinical documentation. Minimization of both legal risk and patient harm can be achieved by carefully selecting patients for chronic opioid therapy and documenting compliance and improvement with the treatment plan. Medical comorbidities such as obstructive sleep apnea and the use of long-acting opioids may be particularly dangerous. Continuing physician education on the safest and most effective approaches to manage these medications in everyday practice will lead to both improved legal security and patient safety.

Measuring and Improving the Quality of Preprocedural Assessments.

BACKGROUND: Preprocedural assessments are used by anesthesia providers to optimize perioperative care for patients undergoing invasive procedures. When these assessments are performed in advance by providers who are not caring for the patient during the procedure, there is an additional layer of complexity in ensuring that the workup meets the needs of the primary anesthesia care team. In this study, anesthesia providers were asked to rate the quality of preprocedural assessments prepared by other providers to evaluate anesthesia care team satisfaction. METHODS: Quality ratings for preprocedural assessments were collected from anesthesia providers on the day of surgery using an electronic quality assurance tool from January 9, 2014 to October 21, 2014. Users could rate assessments as "exemplary," "satisfactory," or "unsatisfactory." Free text comments could be entered for any of the quality ratings chosen. A reviewer trained in clinical anesthesia categorized all comments as "positive," "constructive," or "neutral" and conducted in-depth chart reviews triggered by 67 "constructive" comments submitted during the first 3 months of data collection to further subcategorize perceived deficiencies in the preprocedural assessments. In May 2014, providers were asked to participate in a midpoint survey and provide general feedback about the preprocedural process and evaluations. RESULTS: 37,611 procedures requiring anesthesia were analyzed. Of the 17,522 (46.6%) cases with a rated preprocedural assessment, anesthesia providers rated 3828 (21.8%) as "exemplary," 13,454 (76.8%) as "satisfactory," and 240 (1.4%) as "unsatisfactory." The monthly proportion of "unsatisfactory" ratings ranged from 3.1% to 0% over the study period, whereas the midpoint survey showed that anesthesia providers estimated that the number of unsatisfactory evaluations was 11.5%. Preprocedural evaluations performed on inpatients received significantly better ratings than evaluations performed on outpatients by the preadmission testing clinic or phone program (P < .0001). The most common reason given for "unsatisfactory" ratings was a perception of "missing information" (49.2%). Chart reviews revealed that inadequate documentation was in reality the most common deficiency in preprocedural evaluations (35 of 67 reviews, 52.2%). CONCLUSIONS: The overwhelming majority of preprocedural assessments performed at our institution were considered satisfactory or exemplary by day-of-surgery anesthesia providers. This was demonstrated by both the case-by-case ratings and midpoint survey. However, the perceived frequency of "unsatisfactory" evaluations was worse when providers were asked to reflect on the quality of preprocedural evaluations generally versus rate them individually. Analysis of comments left by providers allowed us to identify specific and actionable areas for improvement. This method can be used by other institutions to identify systemic deficiencies in the preprocedural evaluation process.

A Contemporary Medicolegal Analysis of Implanted Devices for Chronic Pain Management.

BACKGROUND: Analysis of closed malpractice claims allows the study of rare but serious complications and likely results in improved patient safety by raising awareness of such complications. Clinical studies and closed claims analyses have previously reported on the common complications associated with intrathecal drug delivery systems (IDDS) and spinal cord stimulators (SCS). This study provides a contemporary analysis of claims from within the past 10 years. METHODS: We performed a closed claims analysis for a period January 1, 2009 to December 31, 2013 for cases with pain medicine as the primary service. These cases were identified using the Controlled Risk Insurance Company (CRICO) Comparative Benchmarking System (CBS), a database containing more than 300,000 malpractice claims from more than 400 academic and community institutions, representing approximately 30% of malpractice cases in the United States. The clinical narratives, which included medical files, claims files, depositions, and expert witness testimony, were reviewed by the authors, as were the CRICO coded variables, which included algorithmically determined contributing factors to the patient injury. RESULTS: Intrathecal drug delivery systems represented 17 of the closed claims; spinal cord stimulators represented 11 of the closed claims. The most common chronic pain diagnoses for which a device was implanted included failed back surgery syndrome and spasticity. The average total incurred for pain medicine claims was $166,028. Damaging events included IDDS refill errors (eg, subcutaneous administration of medication, reprogramming errors), intraoperative nerve damage, and postoperative infection (eg, epidural abscess, meningitis). High-severity outcomes included nerve damage (eg, paraplegia) and death. Medium-severity outcomes included drug reactions (eg, respiratory arrest from opioid overdose) and the need for reoperation. For both IDDS and SCS, deficits in technical skill were the most common contributing factor to injury, followed by deficits in clinical judgment, communication, and documentation. CONCLUSIONS: Implanted devices used for pain management involve a significant risk of morbidity and mortality. Proper education of providers and patients is essential. Providers must acquire the technical skills required for the implantation and refilling of these devices and the clinical skills required for the identification and management of complications such as intrathecal granuloma. Proper patient selection and clear communication between the provider and the patient about these possible complications are of paramount importance.

Injury and Liability Associated with Implantable Devices for Chronic Pain.

BACKGROUND: Due to an increase in implantable device-related anesthesia pain medicine claims, the authors investigated anesthesia liability associated with these devices. METHODS: After institutional review board approval, the authors identified 148 pain medicine device claims from 1990 or later in the Anesthesia Closed Claims Project Database. Device-related damaging events included medication administration events, infections, hematomas, retained catheter fragments, cerebrospinal fluid leaks, cord or cauda equina trauma, device placed at wrong level, stimulator incorrectly programmed, delay in recognition of granuloma formation, and other issues. RESULTS: The most common devices were implantable drug delivery systems (IDDS; 64%) and spinal cord stimulators (29%). Device-related care consisted of surgical device procedures (n = 107) and IDDS maintenance (n = 41). Severity of injury was greater in IDDS maintenance claims (56% death or severe permanent injury) than in surgical device procedures (26%, P < 0.001). Death and brain damage in IDDS maintenance claims resulted from medication administration errors (n = 13; 32%); spinal cord injury resulted from delayed recognition of granuloma formation (n = 9; 22%). The most common damaging events for surgical device procedures were infections, inadequate pain relief, cord trauma, retained catheter fragments, and subcutaneous hygroma. Care was more commonly assessed as less than appropriate (78%) and payments more common (63%) in IDDS maintenance than in surgical device procedure claims (P < 0.001). CONCLUSIONS: Half of IDDS maintenance claims were associated with death or permanent severe injury, most commonly from medication errors or failure to recognize progressive neurologic deterioration. Practitioners implanting or managing devices for chronic pain should exercise caution in these areas to minimize patient harm.

Persistent opioid use following cesarean delivery: patterns and predictors among opioid-naïve women.

BACKGROUND: The incidence of opioid-related death in women has increased 5-fold over the past decade. For many women, their initial opioid exposure will occur in the setting of routine medical care. Approximately 1 in 3 deliveries in the United States is by cesarean, and opioids are commonly prescribed for postsurgical pain management. OBJECTIVE: The objective of this study was to determine the risk that opioid-naïve women prescribed opioids after cesarean delivery will subsequently become consistent prescription opioid users in the year following delivery and to identify predictors for this behavior. STUDY DESIGN: We identified women in a database of commercial insurance beneficiaries who underwent cesarean delivery and who were opioid naïve in the year prior to delivery. To identify persistent users of opioids, we used trajectory models, which group together patients with similar patterns of medication filling during follow-up, based on patterns of opioid dispensing in the year following cesarean delivery. We then constructed a multivariable logistic regression model to identify independent risk factors for membership in the persistent user group. RESULTS: A total of 285 of 80,127 (0.36%, 95% confidence interval, 0.32-0.40), opioid-naïve women became persistent opioid users (identified using trajectory models based on monthly patterns of opioid dispensing) following cesarean delivery. Demographics and baseline comorbidity predicted such use with moderate discrimination (c statistic = 0.73). Significant predictors included a history of cocaine abuse (risk, 7.41%; adjusted odds ratio, 6.11, 95% confidence interval, 1.03-36.31) and other illicit substance abuse (2.36%; adjusted odds ratio, 2.78, 95% confidence interval, 1.12-6.91), tobacco use (1.45%; adjusted odds ratio, 3.04, 95% confidence interval, 2.03-4.55), back pain (0.69%; adjusted odds ratio, 1.74, 95% confidence interval, 1.33-2.29), migraines (0.91%; adjusted odds ratio, 2.14, 95% confidence interval, 1.58-2.90), antidepressant use (1.34%; adjusted odds ratio, 3.19, 95% confidence interval, 2.41-4.23), and benzodiazepine use (1.99%; adjusted odds ratio, 3.72, 95% confidence interval, 2.64-5.26) in the year prior to the cesarean delivery. CONCLUSION: A very small proportion of opioid-naïve women (approximately 1 in 300) become persistent prescription opioid users following cesarean delivery. Preexisting psychiatric comorbidity, certain pain conditions, and substance use/abuse conditions identifiable at the time of initial opioid prescribing were predictors of persistent use.

A Novel Modified Retrocrural Approach for Celiac Plexus Block: The Single-Needle Retroaortic Technique.

For patients with pain from upper abdominal malignancies, celiac plexus neurolysis can provide an effective means of pain control. However, there are instances when traditionally described percutaneous approaches may not be technically feasible. We describe here the successful use of a novel single-needle retroaortic approach as an alternative approach to celiac plexus neurolysis.We present 4 cases of patients with pain from upper abdominal malignancies in whom we performed celiac plexus neurolysis using a novel single-needle retroaortic approach. All 4 patients had significant pain relief and no significant adverse effects from the retroaortic approach.

Symptoms During or Shortly After Isolated Carpal Tunnel Release and Problems Within 24 hours After Surgery.

This study used the National Survey of Ambulatory Surgery (NSAS) database to measure the incidence of and risk factors for symptoms in the ambulatory surgery center and problems within 24 h after isolated carpal tunnel release (CTR). The NSAS contained records on 400,000 adult patients with carpal tunnel syndrome who were treated with CTR in 2006, based on ICD-9 codes. The type of anesthesia used and factors associated with symptoms and problems were sought in bivariate and multivariable statistical analyses. The mean duration of the procedure was 16 ± 8.8 min. Only 5 % were performed under local anesthesia without sedation, 45 % with IV sedation, 28 % regional anesthesia, and 19 % general anesthesia. Symptoms in the ambulatory surgery center or a problem within 24 h after discharge were recorded in 10 % of patients, all of them minor and transient, including difficulties with pain and its treatment. The strongest risk factors were male sex, age of 45 years and older, and participation of an anesthesiologist. Local anesthesia and regional anesthesia were associated with more perioperative symptoms and postoperative problems. Most CTR are performed with some sedation in the United States. CTR is a safe procedure: one in 10 patients will experience a minor issue in the perioperative or immediate postoperative period.

An open-label comparison of local anesthesia with or without sedation for minor hand surgery.

BACKGROUND: The purpose of this study was to assess satisfaction and pain intensity in patients undergoing minor hand surgery under local anesthesia (LA) with or without sedation. METHODS: Seventy-three adult patients presenting to two hand surgeons were enrolled in this prospective observational study in 2012. They completed questionnaires prior to surgery (current pain intensity, Patient Health Questionnaire-2 (PHQ-2) to measure symptoms of depression, Pain Self-Efficacy Questionnaire (PSEQ) to assess the effective coping strategy of pain self-efficacy) and within 48 h after surgery (satisfaction with surgery, satisfaction with anesthesia, pain during the injection, and pain during the procedure). Thirty-seven patients had carpal tunnel release (bilateral in 3), 22 had release of one or more trigger digits, and 12 had excision of a benign tumor, gouty tophus (1 patient), or foreign body (1 patient). Forty-six patients chose LA and 27 chose LA with sedation. RESULTS: There was no difference in satisfaction with surgery or anesthesia by the type of anesthesia. Satisfaction with surgery was associated with older age alone. Satisfaction with anesthesia was associated with no prior surgery for the same condition. Pain during injection and during the procedure were significantly higher without sedation. Pain during injection was associated with younger age and LA. No factors were associated with pain during the procedure. CONCLUSIONS: Patients that had local anesthesia immediately prior to incision with tourniquet use during surgery had more pain during the procedure but were equally satisfied on average with surgery and with anesthesia compared to patients that had sedation.

Epidural steroids: a comprehensive, evidence-based review.

Epidural steroid injections (ESIs) are the most widely utilized pain management procedure in the world, their use supported by more than 45 placebo-controlled studies and dozens of systematic reviews. Despite the extensive literature on the subject, there continues to be considerable controversy surrounding their safety and efficacy. The results of clinical trials and review articles are heavily influenced by specialty, with those done by interventional pain physicians more likely to yield positive findings. Overall, more than half of controlled studies have demonstrated positive findings, suggesting a modest effect size lasting less than 3 months in well-selected individuals. Transforaminal injections are more likely to yield positive results than interlaminar or caudal injections, and subgroup analyses indicate a slightly greater likelihood for a positive response for lumbar herniated disk, compared with spinal stenosis or axial spinal pain. Other factors that may increase the likelihood of a positive outcome in clinical trials include the use of a nonepidural (eg, intramuscular) control group, higher volumes in the treatment group, and the use of depo-steroid. Serious complications are rare following ESIs, provided proper precautions are taken. Although there are no clinical trials comparing different numbers of injections, guidelines suggest that the number of injections should be tailored to individual response, rather than a set series. Most subgroup analyses of controlled studies show no difference in surgical rates between ESI and control patients; however, randomized studies conducted by spine surgeons, in surgically amenable patients with standardized operative criteria, indicate that in some patients the strategic use of ESI may prevent surgery.

Randomized placebo-controlled study of intravenous methylnaltrexone in postoperative ileus.

OBJECTIVE: This phase 2 study evaluated the safety and activity of intravenous methylnaltrexone on the duration of postoperative ileus in patients undergoing segmental colectomy. METHODS: Adults (aged 18 years or older) with American Society of Anesthesiologists physical status of I, II, or III who underwent segmental colectomy, including partial colectomy, sigmoidectomy, cecectomy, or anterior proctosigmoidectomy, via laparotomy with general anesthesia, received intravenous methylnaltrexone 0.30 mg/kg or placebo every 6 h beginning within 90 min after end of surgery. Treatment continued until 24 h after the patient tolerated solid foods, was discharged, or for 7 d maximum. Efficacy endpoints included measures of gastrointestinal recovery and time to discharge eligibility. RESULTS: A total of 65 patients (methylnaltrexone, n = 33; placebo, n = 32) were randomized. Mean time to first bowel movement was accelerated by 20 h (p = 0.038) and time to discharge eligibility was accelerated by 33 h (p = 0.049) with methylnaltrexone vs placebo. Opioid use was similar between groups until postoperative day 4, then fluctuated in the placebo group. Methylnaltrexone was generally well tolerated. CONCLUSIONS: In this study, intravenous methylnaltrexone significantly decreased time to postoperative bowel recovery and eligibility for hospital discharge by ∼1 d, with an adverse event profile similar to placebo. These were two of several exploratory endpoints; not all efficacy endpoints showed a significant difference between methylnaltrexone and placebo. The efficacy results in this trial were not seen in two subsequent large-scale studies.

Predictors for moderate to severe acute postoperative pain after total hip and knee replacement.

PURPOSE: The ability to identify and focus care to patients at higher risk of moderate to severe postoperative pain should improve analgesia and patient satisfaction, and may affect reimbursement. We undertook this multi-centre cross-sectional study to identify preoperative risk factors for moderate to severe pain after total hip (THR) and knee (TKR) replacement. METHODS: A total of 897 patients were identified from electronic medical records. Preoperative information and anaesthetic technique was gained by retrospective chart review. The primary outcomes were moderate to severe pain (pain score ≥ 4/10) at rest and with activity on postoperative day one. Logistic regression was performed to identify predictors for moderate to severe pain. RESULTS: Moderate to severe pain was reported by 20 % at rest and 33 % with activity. Predictors for pain at rest were female gender (OR 1.10 with 95 % CI 1.01-1.20), younger age (0.96, 0.94-0.99), increased BMI (1.02, 1.01-1.03), TKR vs. THR (3.21, 2.73-3.78), increased severity of preoperative pain at the surgical site (1.15, 1.03-1.30), preoperative use of opioids (1.63, 1.32-2.01), and general anaesthesia (8.51, 2.13-33.98). Predictors for pain with activity were TKR vs. THR (1.42, 1.28-1.57), increased severity of preoperative pain at the surgical site (1.11, 1.04-1.19), general anaesthesia (9.02, 3.68-22.07), preoperative use of anti-convulsants (1.78, 1.32-2.40) and anti-depressants (1.50, 1.08-2.80), and prior surgery at the surgical site (1.28, 1.05-1.57). CONCLUSIONS: Our findings provide clinical guidance for preoperative stratification of patients for more intensive management potentially including education, nursing staffing, and referral to specialised pain management.

A cross-sectional survey on prevalence and risk factors for persistent postsurgical pain 1 year after total hip and knee replacement.

BACKGROUND AND OBJECTIVES: There is a paucity of large multi-institutional surveys to determine the prevalence of and risk factors for persistent pain after total hip (THR) and knee (TKR) replacements. We surveyed a variety of practices and patients and also correlated persistent pain with health-related quality-of-life outcomes. METHODS: From October 10, 2007, to March 15, 2010, patients who had undergone primary THR or TKR with a minimum follow-up of 1 year were identified. A previously published questionnaire to identify persistent postsurgical pain that included a 36-item Short Form Health Survey was mailed to this group. Independent risk factors for persistent pain were identified with logistic regression. RESULTS: Responses from 1030 patients who underwent surgery at some point in time between June 13, 2006, and June 24, 2009, were analyzed (32% response rate). Forty-six percent of patients reported persistent pain (38% after THR and 53% after TKR) with a median average pain score of 3 of 10 and worst pain score of 5. Independent risk factors for persistent pain were female sex (odds ratio [OR], 1.23), younger age (OR, 0.97), prior surgery on hip or knee (OR, 1.39), knee versus hip replacement (OR, 1.65), lower-quality postsurgical pain control (OR, 0.9), and presence of pain in other areas of the body (OR, 2.09). All scores in the 36-item Short Form Health Survey were worse (8%-28% decrease) in patients with persistent postsurgical pain (P < 0.001). CONCLUSIONS: Persistent postsurgical pain is common after THR and TKR and is associated with reduced health-related quality of life, although our survey may be biased by the low response rate and retrospective recall bias. Nonmodifiable risk factors may lead to risk stratification. Severity of acute postoperative pain may be a modifiable risk factor.