Multimodal nonopioid pain protocol provides equivalent pain control versus opioids following arthroscopic shoulder labral surgery: a prospective randomized controlled trial
Abstract
Background: This study aimed to compare postoperative pain and patient satisfaction in patients undergoing primary arthroscopic labral surgery managed with either a nonopioid alternative pain regimen or a traditional opioid pain regimen.
Methods: Sixty consecutive patients undergoing primary arthroscopic shoulder labral surgery were assessed for participation. In accordance with the Consolidated Standards of Reporting Trials (CONSORT) 2010 statement, a prospective randomized controlled trial was performed. The 2 arms of the study were a multimodal nonopioid analgesic protocol as the experimental group and a standard opioid regimen as the control group. The primary outcome was postoperative pain scores (on a visual analog scale [VAS]) for the first 10 days postoperatively. Secondary outcomes included patient satisfaction, patient-reported outcomes, and complications. Randomization was performed with a random number generator, and all data were collected by blinded observers. Patients were not blinded.
Results: Twelve patients did not meet the inclusion criteria or declined to participate. Thus, 48 patients were included in the final analysis: 24 in the nonopioid group and 24 in the opioid group. There was no significant difference in VAS or PROMIS (Patient-Reported Outcomes Measurement Information System) scores between patients in the 2 cohorts on any postoperative day (P > .05). When we controlled for confounding factors with repeated-measures mixed models, the nonopioid cohort reported significantly lower VAS and PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Interference scores (P < .01) at all time points. No difference was found in reported adverse events (constipation, diarrhea, drowsiness, nausea, and upset stomach) between cohorts at any time point (P > .05).
Conclusion: This study found that a multimodal nonopioid pain regimen provided, at the minimum, equivalent pain control, an equivalent adverse reaction profile, and equivalent patient satisfaction when compared with a standard opioid-based regimen following arthroscopic shoulder labral surgery.