Paper 03: Multimodal Pain Regimen is Equivalent to Opioid Analgesia Following Arthroscopic Rotator Cuff Surgery: A Prospective Randomized Controlled Trial

Abstract

Objectives:To evaluate the efficacy of a multimodal non-opioid analgesic protocol in controlling postoperative pain compared to opioids following a primary arthroscopic rotator cuff repair.Methods:Seventy consecutive patients undergoing a primary rotator cuff repair were assessed eligibility. A prospective randomized controlled trial was designed in accordance with the Consolidated Standards of Reporting Trials 2010 (CONSORT) statement. The two arms of the study included a multimodal non-opioid pain regimen for the experimental group, and a standard of care narcotics for the control group. The primary outcome was visual analog scale (VAS) pain scores for the first ten postoperative days. Secondary outcomes included PROMIS-PI, patient satisfaction, and adverse drug events. Patients were randomized using a random number generator. Whiles patients were not blinded to their treatment group, all reported outcomes were collected by blinded observers.Results:Twenty-six patients either declined to participate or were excluded from the study. Forty-four patients were included in the final analysis. A total of 27 patients were in the traditional group and 17 patients were in the nonopioid group. Patients in the traditional pain control group reported a significantly lower VAS pain score on post-operative day 1 (opioid: 5.7 ± 2, nonopioid: 3.7 ± 2.2, p=0.011) and post-operative day 4 (opioid: 4.4 ± 2.7, nonopioid: 2.4 ± 2.2, p=0.023). No significant difference was seen on any other postoperative day. When mixed measured models were used to control for confounding factors the non-opioid group demonstrated significantly lower VAS and PROMIS-PI scores (p<0.01) at every time point. The most commonly reported side effects for patients in both groups were drowsiness (opioid: 2.7 ± 3.3 days, nonopioid: 1.9 ± 3.3 days) and constipation (opioid: 2.2 ± 2.9 days, nonopioid: 0.2 ± 0.6 days). Patients in the traditional analgesia group reported significantly greater average number of days with constipation (opioid: 2.2 ± 2.9, nonopioid: 0.2 ± 0.6, p=0.003) and days with upset stomach (opioid: 1.3 ± 2.5, nonopioid: 0.0 ± 0.0, p=0.020) than those in the nonopioid group.Conclusions:This study found that a multimodal nonopioid pain protocol provided at least equivalent pain control compared to traditional opioid analgesics in patients undergoing primary arthroscopic rotator cuff repair. Minimal side effects were noted with some improvement in the multimodal nonopioid pain cohort, and all patients reported satisfaction with their pain management.