Template protocol for randomized clinical trials on reducing long-term postoperative opioid use

The prevalence of long-term opioid use after orthopaedic surgery varies from 1.4% to 24% and has mostly been studied with prescription data, making it difficult to estimate the size and impact of the problem. This study aims to assess the prevalence and predictors of long-term postoperative opioid use in a high volume and tertiary orthopaedic centre by using online patient reported measures. This Dutch prospective cohort study was conducted among adult patients who underwent any type of orthopaedic surgery from June to August 2021. Six months after surgery patients were invited to complete an online survey on current opioid use and patients' willingness to taper opioids. The demographics, clinical factors and preoperative opioid use were extracted from the patient file. In total, 607 patients (mean age 61.2 years, 63.4% female) completed the survey. Seventy-six patients (12.5%) used opioids 6 months after surgery of which 20 (3.3%) did not use opioids before surgery. The median (Q1-Q3) postoperative daily dose after 6 months was 29.9 mg (10.0-76.1) morphine equivalents. Most of them (88.2%) wanted to taper opioids. Affected body region (OR's: 6.84-12.75) and pre-operative opioid use (OR = 35.33) were significant predictors of long-term opioid use. The prevalence of long-term postoperative opioid use was 12.5%; one in thirty patients became a new long-term opioid user. Pre-operative opioid use and affected body region were predictive for long-term opioid use. These findings, together with the observation that long-term opioid users want to taper opioids, emphasize the relevance of prevention, recognition and tapering support in the perioperative setting. Level II. Short-term opioid use can unintentionally progress to long-term opioid use. The prevalence of long-term opioid use after orthopaedic surgery varies widely and is mostly prescription-based, making it difficult to estimate the magnitude of the problem. This study assessed long-term postoperative opioid use in a full breadth orthopaedic population using patient reported measures, making conclusions much more robust. The prevalence of long-term postoperative opioid use in this study was 12.5%.

Although the development of persistent opioid use after surgical procedures has garnered much attention in recent years, large-scale studies characterizing patterns of persistent opioid use among patients undergoing plastic and reconstructive surgery procedures are lacking. To assess the prevalence of immediate and long-term postoperative opioid use after plastic and reconstructive surgery procedures. In this population-based cohort study, patients who underwent 5 classes of plastic and reconstructive procedures (nasal, eye, breast, abdomen, and soft tissue reconstruction) between January 1, 2007, and December 31, 2015, were identified using IBM MarketScan Commercial and Medicare Supplemental research databases. Patients were excluded if they were younger than 18 years, lacked continuous insurance coverage for 1 year preoperatively and postoperatively, had a second anesthesia event within 1 year postoperatively, and filled an opioid prescription within the year prior to surgery. Analgesic prescription patterns in the immediate postoperative period. The primary outcome was rates of persistent opioid use (opioid prescriptions filled 90-180 days postoperatively). The secondary outcome was rates of prolonged opioid use (opioid prescriptions filled 90-180 days postoperatively and again 181-365 days postoperatively). Explanatory variables included patient demographics, procedure type, and relevant comorbidities. Of the 466 677 patients who met inclusion criteria, 96 397 (45.3%) were men, and the mean (SD) age was 46.8 (17.7) years. Furthermore, 212 387 (54.6%) of the patients filled prescriptions for postoperative analgesics, with 212 387 (91.5%) of analgesic prescriptions filled being for opioids. Persistent opioid use occurred in 30 865 (6.6%) patients (5.1%-13.5% across procedure classes), while prolonged opioid use occurred in 10 487 (2.3%) patients (1.7%-5.6% across procedure classes). Patients who filled prescriptions for opioids in the perioperative period were significantly more likely to exhibit persistent (odds ratio [OR], 2.87; 95% CI, 2.80-2.94) and prolonged (OR, 2.90; 95% CI, 2.77-3.02) opioid use than those who did not fill perioperative opioid prescriptions, with the greatest odds for persistent use found in patients who underwent breast (OR, 4.36; 95% CI, 4.10-4.63) and nasal (OR, 3.51; 95% CI, 3.30-3.73) procedures. On multivariable logistic regression analysis, independent risk factors for persistent and prolonged opioid use included perioperative opioid use, procedure type, and prior-year mental health (depression and anxiety) and substance abuse diagnoses. Given the significant risk of persistent opioid use after plastic and reconstructive procedures, it is imperative to develop best practices guidelines for postoperative opioid prescription practices in this population. NA.

IntroductionOperative management of spinal metastatic disease is largely for symptom palliation and revolves around the expectation that postoperative survival will exceed the recovery period. Long-term postoperative opioid use is a clinically useful indicator of recovery. Few studies have developed machine learning models to predict this outcome in spinal metastatic disease patients.MethodsThe Merative™ Marketscan® Commercial Database and Medicare Supplement were analyzed to identify adult patients who underwent surgery for extradural spinal metastatic disease between 2006 and 2023. Patients were required to have at least 6 months of continuous preadmission data, and 6 months of continuous post-discharge follow-up. The primary outcome was prolonged opioid use, defined as filling a perioperative prescription followed by another between 90- and 180-days post-discharge. Cumulative days of postoperative opioid supply was assessed as a secondary outcome. Five models (stochastic gradient boosting, support vector machine, neural network, random forest and penalized logistic regression) were trained on a 70% training sample and validated on the withheld 30%.ResultsA total of 732 patients were included, of which 341 (46.6%) had prolonged post-discharge opioid use. The random forest algorithm had the best predictive performance in terms of discrimination (area under the curve [AUC]: 0.611), calibration (intercept: 0.18, slope: 0.613) and overall accuracy (Brier score: 0.24).ConclusionWe developed and validated parsimonious predictive models to estimate risk of prolonged opioid use after surgery for extradural spinal metastatic disease. Integrating these models into physician- and patient-facing interfaces may improve prognostication, enhance clinical decision-making, and ultimately optimize pain management to support more tailored postoperative care strategies.

Opioids are prescribed routinely for pain after total shoulder arthroplasty (TSA). This study was designed to characterize opioid use after elective primary TSA and identify predictors of long-term postoperative opioid use. The authors used the MarketScan administrative claims database to identify 5676 adults who underwent elective primary TSA between 2010 and 2015 and had 1 year or more of continuous insurance enrollment, including prescription drug coverage, postoperatively. Long-term postoperative opioid use was defined as filling prescriptions totaling a 120-day or greater supply during the 3- to 12-month postoperative period. The authors performed univariate regression analysis with age, sex, US region, anatomic or reverse TSA, anxiety, chronic obstructive pulmonary disease, congestive heart failure, depression, diabetes, history of drug abuse, hypertension, obesity, osteoporosis, history of myocardial infarction, and current tobacco use. Variables that were significant at P<.05 were included in multivariate logistic regression. Overall, 16% of patients had long-term postoperative opioid use, which was strongly predicted by the multivariate model (area under the curve, 0.77; P<.001). The strongest predictors in the multivariate analysis were preoperative opioid use (odds ratio [OR], 4.7; 95% CI, 4.0-5.5), history of drug abuse (OR, 2.5; 95% CI, 1.3-4.9), depression (OR, 1.9; 95% CI, 1.6-2.3), anxiety (OR, 1.4; 95% CI, 1.2-1.7), surgery performed in the Western United States (OR, 1.8; 95% CI, 1.3-2.4), and reverse TSA (OR, 1.5; 95% CI, 1.2-1.8). Most patients do not have long-term opioid use after elective primary TSA. Strong predictors of long-term postoperative opioid use are preoperative opioid use, history of drug abuse, depression, anxiety, reverse TSA, and surgery performed in the Western United States. [Orthopedics. 2021;44(1):58-63.].

Background: Little is known regarding the rates and risk factors for long-term postoperative opioid use among opioid-naïve patients undergoing elective shoulder surgery. Purpose: To identify (1) the proportion of opioid-naïve patients undergoing elective shoulder surgery, (2) the rates of postoperative opioid use among these patients, and (3) the risk factors associated with long-term postoperative opioid use. Study Design: Cohort study; Level of evidence, 3. Methods: A retrospective review of a private administrative claims database was performed to identify those individuals who underwent elective shoulder surgery between 2007 and 2015. “Opioid-naïve” patients were identified as those patients who had not filled an opioid prescription in the 180 days before the index surgery. Within this subgroup, we tracked postoperative opioid prescription refill rates and used a logistic regression to identify patient variables that were predictive for long-term opioid use, which we defined as continued opioid refills beyond 180 days after surgery. Results were reported as odds ratios (ORs). Results: Over the study period, 79,287 patients were identified who underwent elective shoulder surgery, of whom 79.5% were opioid naïve. Among opioid-naïve patients, the rate of postoperative opioid use declined over time, and 14.6% of patients were still using opioids beyond 180 days. The greatest proportion of opioid-naïve patients still filling opioid prescriptions beyond 180 days postoperatively was seen after open rotator cuff repair (20.9%), whereas arthroscopic labral repair had the lowest proportion (9.8%). Overall, a history of alcohol abuse (OR 1.56), a history of depression (OR 1.46), a history of anxiety (OR, 1.31), female sex (OR, 1.11), and higher Charlson Comorbidity Index (OR 1.02) had the most significant influence on the risk for long-term opioid use among opioid naïve patients. Conclusions: Most patients were opioid naïve before elective shoulder surgery; however, among opioid-naïve patients, 1 in 7 patients were still using opioids beyond 180 days after surgery. Among all variables, a history of mental illness most significantly increased the risk of long-term opioid use after elective shoulder surgery.

Long-term opioid use has negative health care consequences. Opioid-naïve adults are at risk for prolonged and persistent opioid use after surgery. While these outcomes have been examined in some adolescent and teenage populations, little is known about the risk of prolonged and persistent postoperative opioid use after common surgeries compared to children who do not undergo surgery and factors associated with these issues among pediatric surgical patients of all ages. Using a national administrative claims database, we identified 175,878 surgical visits by opioid-naïve children aged ≤18 years who underwent ≥1 of the 20 most common surgeries from each of 4 age groups between December 31, 2002, and December 30, 2017, and who filled a perioperative opioid prescription 30 days before to 14 days after surgery. Prolonged opioid use after surgery (filling ≥1 opioid prescription 90-180 days after surgery) was compared to a reference sample of 1,354,909 nonsurgical patients randomly assigned a false "surgery" date. Multivariable logistic regression models were used to estimate the association of surgical procedures and 22 other variables of interest with prolonged opioid use and persistent postoperative opioid use (filling ≥60 days' supply of opioids 90-365 days after surgery) for each age group. Prolonged opioid use after surgery occurred in 0.77%, 0.76%, 1.00%, and 3.80% of surgical patients ages 0-<2, 2-<6, 6-<12, and 12-18, respectively. It was significantly more common in surgical patients than in nonsurgical patients (ages 0-<2: odds ratio [OR] = 4.6 [95% confidence interval (CI), 3.7-5.6]; ages 2-<6: OR = 2.5 [95% CI, 2.1-2.8]; ages 6-<12: OR = 2.1 [95% CI, 1.9-2.4]; and ages 12-18: OR = 1.8 [95% CI, 1.7-1.9]). In the multivariable models for ages 0-<12 years, few surgical procedures and none of the other variables of interest were associated with prolonged opioid use. In the models for ages 12-18 years, 10 surgical procedures and 5 other variables of interest were associated with prolonged opioid use. Persistent postoperative opioid use occurred in <0.1% of patients in all age groups. Some patient characteristics and surgeries are positively and negatively associated with prolonged opioid use in opioid-naïve children of all ages, but persistent opioid use is rare. Specific pediatric subpopulations (eg, older patients with a history of mood/personality disorder or chronic pain) may be at markedly higher risk.

Opioids are commonly used after posterior spinal instrumented fusion (PSIF) for adolescent idiopathic scoliosis (AIS). Prescription opioids use can potentially lead to misuse, abuse, dependence, and overdose death. Prolonged opioid use has not been extensively studied in the postoperative AIS population. The purpose of this study is to identify risk factors associated with prolonged opioid use after PSIF for AIS. A large insurance database was queried for AIS patients undergoing PSIF. Patients with prolonged postoperative opioid use were defined as those receiving new prescriptions for an opioid medication >6 weeks following the date of surgery, up to 8 months postoperatively. Preoperative and intraoperative risk factors for prolonged opioid use were then examined, including the number of spinal levels fused, preoperative opioid prescriptions, demographic variables, pertinent comorbidities (anxiety, depression, attention deficit hyperactivity disorder, and autism) and other preoperative prescriptions (anxiolytics, antidepressants, nonopioid analgesics, neuropathic medications, and attention deficit hyperactivity disorder medications). Each variable's independent risk for prolonged postoperative opioid use was examined utilizing a multivariable binomial regression analysis. P<0.05 was considered statistically significant. A total of 511 patients were included in the study. Of this 50 patients (9.78%) were found to have prolonged opioid use following scoliosis surgery. Preoperative opioid use (odds ratio, 2.93; P<0.001) was the most significant predictor of prolonged postoperative opioid use. In addition, female sex, obesity, a preoperative diagnosis of anxiety and a preoperative prescription for a muscle relaxer were also significant positive risk factors for prolonged postoperative opioid use. Several factors were found to be protective against prolonged postoperative opioid use. Fewer total fusion levels, compared with ≥13 levels, had a significantly lower risk of prolonged opioid use. Preoperative anxiolytic and antidepressant use were also both negative predictors of prolonged opioid use. Efforts at addressing preoperative opioid use, anxiety, obesity, and providing multimodal pain management strategies should be considered to reduce additional postoperative opioid prescriptions after PSIF for AIS. Level III-retrospective comparative study.

Background: Machine learning (ML) has emerged as a method to determine patient-specific risk for prolonged postoperative opioid use after orthopedic procedures. Purpose: We sought to analyze the efficacy and validity of ML algorithms in identifying patients who are at high risk for prolonged opioid use following orthopedic procedures. Methods: PubMed, EMBASE, and Web of Science Core Collection databases were queried for articles published prior to August 2021 for articles applying ML to predict prolonged postoperative opioid use following orthopedic surgeries. Features pertaining to patient demographics, surgical procedures, and ML algorithm performance were analyzed. Results: Ten studies met inclusion criteria: 4 spine, 3 knee, and 3 hip. Studies reported postoperative opioid use over 30 to 365 days and varied in defining prolonged use. Prolonged postsurgical opioid use frequency ranged from 4.3% to 40.9%. C-statistics for spine studies ranged from 0.70 to 0.81; for knee studies, 0.75 to 0.77; and for hip studies, 0.71 to 0.77. Brier scores for spine studies ranged from 0.039 to 0.076; for knee, 0.01 to 0.124; and for hip, 0.052 to 0.21. Seven articles reported calibration intercept (range: -0.02 to 0.16) and calibration slope (range: 0.88 to 1.08). Nine articles included a decision curve analysis. No investigations performed external validation. Thematic predictors of prolonged postoperative opioid use were preoperative opioid, benzodiazepine, or antidepressant use and extremes of age depending on procedure population. Conclusions: This systematic review found that ML algorithms created to predict risk for prolonged postoperative opioid use in orthopedic surgery patients demonstrate good discriminatory performance. The frequency and predictive features of prolonged postoperative opioid use identified were consistent with existing literature, although algorithms remain limited by a lack of external validation and imperfect adherence to predictive modeling guidelines.

This study aims to identify clinical and socioeconomic factors associated with long-term, post-surgical opioid use in the head and neck cancer population. A single center retrospective study was conducted including patients diagnosed with head and neck cancer between January 1, 2014 and July 1, 2019 who underwent primary surgical management. The primary outcome measure was continued opioid use 6 months after treatment completion. Both demographic and cancer-related variables were recorded to determine what factors were associated with prolonged opioid use. Univariate analysis was performed using chi-squared test for categorical variables and 2-sample t-test for continuous variables. Multivariate analysis was performed using logistic regression. A total of 359 patients received primary surgical management. Forty-five patients (12.53%) continued to take opioids 6 months after treatment completion. Using univariate analysis, patients less than 65 years of age (P = .0126), adjuvant chemoradiation (n = 25, P < .001), and overall length of hospital stay (8.60 ± 8.58 days, P = .0274) were significantly associated with long term opioid use. Multivariate logistic regression showed that adjuvant chemoradiation (OR = 3.446, 95% CI [1.742, 6.820], P = .0004) and overall length of hospital stay (OR = 0.949, 95% CI [0.903, 0.997], P = .0373) to be significantly associated with opioid use 6 months after head and neck cancer treatment. Long-term postoperative opioid use in head and neck cancer patients is significantly associated with adjuvant chemoradiation, and patients with longer length of hospital stay. Therefore, future research should focus on interventions to better manage opioid use during the acute treatment period to decrease long-term use.

Background:Prolonged opioid use after surgery has been a contributing factor to the ongoing opioid epidemic. The purpose of this systematic review is to analyze the definitions of prolonged opioid use in prior literature and propose appropriate criteria to define postoperative prolonged opioid use in hand surgery.Methods:Using Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines 130 studies were included for review. The primary outcome was the timepoint used to define prolonged opioid use following surgery. The proportion of patients with prolonged use and risk factors for prolonged use were also collected for each study. Included studies were categorized based on their surgical specialty.Results:The most common timepoint used to define prolonged opioid use was 3 months (n = 86, 67.2% of eligible definitions), ranging from 1 to 24 months. Although 11 of 12 specialties had a mean timepoint between 2.5 and 4.17 months, Spine surgery was the only outlier with a mean of 6.90 months. No correlation was found between the definition’s timepoint and the rates of prolonged opioid use.Conclusions:Although a vast majority of the literature reports similar timepoints to define prolonged postoperative opioid use, these studies often do not account for the type of procedures being performed. We propose that the definitions of postoperative prolonged opioid use should be tailored to the level and duration of pain for specific procedures. We present criteria to define prolonged opioid use in hand surgery.

The Impact of Patient Characteristics and Postoperative Opioid Exposure on Prolonged Postoperative Opioid Use: An Integrative Review

Opioid-related deaths have increased substantially over the last 10years placing clinician's prescription practices under intense scrutiny. Given the substantial risk of opioid dependency after colorectal surgery, we sought to analyze risk of postoperative prolonged opioid use after colorectal resections. Between 2008 and 2014, patients undergoing abdominopelvic procedure with intestinal resection at a tertiary care facility were retrospectively identified. Patient's postoperative narcotic usage including their prescriptions on discharge and their total opioid medication use was recorded. Patient variables such as demographics, surgical characteristics, and prescription use were evaluated. Finally, we developed multivariate models to identify risk factors for prolonged opioid use (> 30 days after incident surgical procedure). We identified 9423 recorded procedures of which 2173 consisted of abdominopelvic procedures with intestinal resection and survived > 1year. Of these, 91% (n = 1981) were discharged on opioids, and 98% (n = 1955) of those patients filled only one prescription. A total of 92 (4%) patients remained on opioids beyond 30days, and from this group, 25% (n = 23 patients) remained at 90days. We found no association between postoperative complications, stoma formation, and patient's sex with risk of prolonged opioid use. However, younger age and history of chronic pain were associated with an increased risk of prolonged opioid use. The use of minimally invasive techniques also attenuated the risk of prolonged opioid use (Table 2). A small but considerable proportion of patients remain on opioids beyond 30 days. Predictors of opioid use for greater than 30 days include a history of chronic pain and younger age. The use of minimally invasive techniques reduced the risk of prolonged opioid use. We identified several immutable risk factors that predicted prolonged postoperative opioid use; however, surgeons may be able to attenuate prolonged opioid use through the use of minimally invasive techniques.

A predictive-modeling based screening tool for prolonged opioid use after surgical management of low back and lower extremity pain

The purpose of this comprehensive review was to investigate risk factors associated with prolonged opioid use after orthopaedic procedures. A comprehensive review of the opioid literature may help to better guide preoperative management of expectations as well as opioid-prescribing practices. A systematic review of all studies pertaining to opioid use in relation to orthopaedic procedures was conducted using the MEDLINE, Embase, and CINAHL databases. Data from studies reporting on postoperative opioid use at various time points were collected. Opioid use and risk of prolonged opioid use were subcategorized by subspecialty, and aggregate data for each category were calculated. There were a total of 1,445 eligible studies, of which 45 met inclusion criteria. Subspecialties included joint arthroplasty, spine, trauma, sports, and hand surgery. A total of 458,993 patients were included, including 353,330 (77%) prolonged postoperative opioid users and 105,663 (23%) non-opioid users. Factors associated with prolonged postoperative opioid use among all evaluated studies included body mass index (BMI) of ≥40 kg/m (relative risk [RR], 1.06 to 2.32), prior substance abuse (RR, 1.08 to 3.59), prior use of other medications (RR, 1.01 to 1.46), psychiatric comorbidities (RR, 1.08 to 1.54), and chronic pain conditions including chronic back pain (RR, 1.01 to 10.90), fibromyalgia (RR, 1.01 to 2.30), and migraines (RR, 1.01 to 5.11). Age cohorts associated with a decreased risk of prolonged postoperative opioid use were those ≥31 years of age for hand procedures (RR, 0.47 to 0.94), ≥50 years of age for total hip arthroplasty (RR, 0.70 to 0.80), and ≥70 years of age for total knee arthroplasty (RR, 0.40 to 0.80). Age cohorts associated with an increased risk of prolonged postoperative opioid use were those ≥50 years of age for sports procedures (RR, 1.11 to 2.57) or total shoulder arthroplasty (RR, 1.26 to 1.40) and those ≥70 years of age for spine procedures (RR, 1.61). Identified risk factors for postoperative use were similar across subspecialties. We provide a comprehensive review of the various preoperative and postoperative risk factors associated with prolonged opioid use after elective and nonelective orthopaedic procedures. Increased BMI, prior substance abuse, psychiatric comorbidities, and chronic pain conditions were most commonly associated with prolonged postoperative opioid use. Careful consideration of elective surgical intervention for painful conditions and perioperative identification of risk factors within each patient's biopsychosocial context will be essential for future modulation of physician opioid-prescribing patterns. Prognostic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Baseline Risk Factors for Prolonged Opioid Use Following Spine Surgery: Systematic Review and Meta-Analysis