Feasibility of Prospectively Comparing Opioid Analgesia With Opioid-Free Analgesia After Outpatient General Surgery

Abstract

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 ...

Investigating Opioid-Free Analgesia—Practice Makes Perfect

“…Of course, the novelty of the study by Do et al is not in the desire to identify an optimal strategy for managing postoperative pain but in specifically establishing the feasibility of studying the impact of opioid-free pain management. This extends at least in part from literature that showed that rates of new persistent opioid use, defined as previously opioid-naive patients filling opioid prescriptions more than 90 days after their index procedure, were 5.9% and 6.5% after minor and major surgery, respectively .…”

“…As the medical community continues to highlight the many causes and consequences of the present opioid crisis in North America, opioid-free perioperative analgesia has emerged as one potential strategy to mitigate a key factor associated with chronic opioid use. It was with interest, then, that I reviewed the article by Do and colleagues, written on behalf of the McGill Better Opioid Prescribing Collaboration. The authors detailed the results of an assessor-blinded, pragmatic pilot randomized clinical trial investigating the feasibility of conducting a full comparative effectiveness trial of prescribing postoperative opioid analgesia compared with opioid-free analgesia among patients undergoing outpatient general surgery.…”

“…Do et al did not purport to solve the opioid crisis but rather provided an initial step toward the rational investigation of postoperative pain management through chiefly nonopioid regimens. Determining the feasibility of such a study is paramount because this approach runs counter to the culture of pain management in North America, where opioid-based analgesia is used at a rate many times higher than that in other industrialized settings .…”

“…Determining the feasibility of such a study is paramount because this approach runs counter to the culture of pain management in North America, where opioid-based analgesia is used at a rate many times higher than that in other industrialized settings . One of the most common barriers to participation in the study by Do et al was preconceptions of the patients about the efficacy of opioid-free analgesia . This is likely true among physicians and health care teams as well.…”

“…As a result, it is necessary to prove not only that a trial of this sort can be conducted in the present health care practice environment but also that the trial methods maintain the necessary rigor to truly assess for therapeutic equipoise. There is reason to be optimistic about the latter because Do et al used many traditional pain-related end points, comprehensive patient-reported assessment tools, and relevant clinical outcomes, and their preliminary data suggest that opioid-free analgesia may translate to a broader patient sample.…”