Background: Excessive opioid prescribing after surgery has been recognised as a contributor to the current crisis of opioid addiction and overdose. Clinicians may potentially tackle this crisis by using opioid-free postoperative analgesia; however, the scientific literature addressing this approach is sparse and heterogeneous, thereby limiting robust conclusions. A scoping review was conducted to systematically map the extent, range, and nature of the literature addressing postoperative opioid-free analgesia. Methods: Eight bibliographic databases were searched for studies addressing opioid-free analgesia after a major surgery. We extracted the study characteristics, including design, country, year, surgical procedure(s), and interventions. Results were organised thematically according to surgical specialty and targeted phase of recovery: in hospital (early recovery, 24 h after operation; intermediate recovery, >24 h) and post-discharge (late recovery). Reporting was according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement for scoping reviews. Results: We identified 424 studies addressing postoperative opioid-free analgesia. The number of studies conducted in countries where the opioid crisis is primarily focused was remarkably low (USA, n¼11 [3%]; Canada, n¼5 [1%]). Many RCTs compared opioid-free vs opioid analgesia during hospital stay (n¼117), but few targeted analgesia post-discharge (n¼8). Studies were predominantly focused on procedures in orthopaedic, general, and gynaecological/obstetric surgery. Limited attention has been directed towards non-pharmacological pain interventions. We did not identify knowledge synthesis studies (i.e. systematic reviews and meta-analyses) focused on the comparative effectiveness of opioid-free vs opioid analgesia. Conclusions: Opioids remain a mainstay analgesic for managing pain after surgery, but alternative analgesia strategies should not be overlooked. This scoping review indicates numerous opportunities for future research targeting opioid-free postoperative analgesia. Review registration: http://www.researchregistry.com; ID: reviewregistry576.
IMPORTANCEThe overprescription of opioids to surgical patients is recognized as an important factor contributing to the opioid crisis. However, the value of prescribing opioid analgesia (OA) vs opioid-free analgesia (OFA) after postoperative discharge remains uncertain. OBJECTIVE To investigate the feasibility of conducting a full-scale randomized clinical trial (RCT) to assess the comparative effectiveness of OA vs OFA after outpatient general surgery. DESIGN, SETTING, AND PARTICIPANTSThis parallel, 2-group, assessor-blind, pragmatic pilot RCT was conducted from January 29 to September 3, 2020 (last follow-up on October 2, 2020). at 2 university-affiliated hospitals in Montreal, Quebec, Canada. Participants were adult patients (aged Ն18 years) undergoing outpatient abdominal (ie, cholecystectomy, appendectomy, or hernia repair) or breast (ie, partial or total mastectomy) general surgical procedures. Exclusion criteria were contraindications to drugs used in the trial, preoperative opioid use, conditions that could affect assessment of outcomes, and intraoperative or early complications requiring hospitalization. INTERVENTIONSPatients were randomized 1:1 to receive OA (around-the-clock nonopioids and opioids for breakthrough pain) or OFA (around-the-clock nonopioids with increasing doses and/or addition of nonopioid medications for breakthrough pain) after postoperative discharge. MAIN OUTCOMES AND MEASURESMain outcomes were a priori RCT feasibility criteria (ie, rates of surgeon agreement, patient eligibility, patient consent, treatment adherence, loss to follow-up, and missing follow-up data). Secondary outcomes included pain intensity and interference, analgesic intake, 30-day unplanned health care use, and adverse events. Between-group comparison of outcomes followed the intention-to-treat principle.RESULTS A total of 15 surgeons were approached; all (100%; 95% CI, 78%-100%) agreed to have patients recruited and adhered to the study procedures. Rates of patient eligibility and consent were 73% (95% CI, 66%-78%) and 57% (95% CI, 49%-65%), respectively. Seventy-six patients were randomized (39 [51%] to OA and 37 [49%] to OFA) and included in the intention-to-treat analysis (mean [SD] age, 55.5 [14.5] years; 50 [66%] female); 40 (53%) underwent abdominal surgery, and 36 (47%) underwent breast surgery. Seventy-five patients (99%; 95% CI, 93%-100%) adhered to the allocated treatment; 1 patient randomly assigned to OFA received an opioid prescription.Seventeen patients (44%) randomly assigned to OA consumed opioids after discharge. Seventythree patients (96%; 95% CI, 89%-99%) completed the 30-day follow-up. The rate of missing questionnaires was 37 of 3724 (1%; 95% CI, 0.7%-1.4%). All the a priori RCT feasibility criteria were fulfilled. (continued) Key Points Question Is it feasible to conduct a randomized clinical trial (RCT) comparing opioid analgesia with opioidfree analgesia after outpatient general surgery? Findings In this pilot RCT, 76 patients were randomized 1:1 to receive opioid or opioid-free analgesia ...
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