Effects of an opioid-free care pathway vs. opioid-based standard care on postoperative pain and postoperative quality of recovery after laparoscopic bariatric surgery: A multicentre randomised controlled trial

Abstract

BACKGROUNDOpioid-free anaesthesia (OFA) may enhance postoperative recovery after bariatric surgery, but its combined effect with opioid-free interventions has not been studied.OBJECTIVE(S)To compare postoperative pain and recovery after laparoscopic bariatric surgery with a total opioid-free care pathway and conventional opioid-based treatment.DESIGNA multicentre nonblinded controlled trial.SETTINGTwo university hospitals in Sweden.PATIENTSAdult patients scheduled for laparoscopic bariatric surgery were enrolled between May 2019 and November 2023. Of 837 patients screened, 112 were randomised, and 110 were included in the analysis: 55 in the intervention and 55 in the control group.INTERVENTION(S)Patients were randomised to an opioid-based standard care (control group) or to an opioid-free care pathway (intervention group), including intraoperative OFA and postoperative first-line transcutaneous electrical nerve stimulation (TENS) treatment.MAIN OUTCOME MEASURESThe primary outcome was the change in patient-reported postoperative pain intensity on a numerical rating scale (NRS) from arrival in the postanaesthesia care unit (PACU) until discharge to the surgical ward. Key secondary outcomes were postoperative pain intensity, in-hospital opioid consumption, and postoperative quality of recovery scale (PQRS) scores.RESULTSThere was no difference between the groups regarding the changes in pain intensity from arrival in PACU until discharge to the ward, with mean ± SD changes in NRS of 3.20 ± 3.01 (intervention) vs. 3.15 ± 2.25 (control); mean difference (MD) 0.04 [(95% confidence interval (CI),-1.00 to 1.08); P = 0.97], and pain intensity at 24 h (P = 0.078), 72 h (P = 0.060), and 3 months (P = 0.30) postoperatively. The intervention group had a significantly lower opioid consumption in the PACU; mean morphine equivalents 6.08 ± 12.31 vs. 51.1 ± 14.9 mg; MD-45.0 (95% CI,-50.1 to-39.8) mg; P < 0.0001; and during the hospital stay MD-40.3 (95% CI,-54.4 to-25.9) mg; P < 0.0001. Total PQRS scores did not differ significantly over the 3-month follow-up.CONCLUSIONThe opioid-free care pathway offers patients pain relief and recovery outcomes comparable to conventional opioid-based care and reduces opioid use after laparoscopic bariatric surgery.TRIAL REGISTRATIONClinicalTrials.gov NCT03756961.