Opioid-Free Analgesia is Safe and Effective in Anterior Cervical Spine Surgery: A Randomized Controlled Trial.

Abstract

Randomized controlled trial (RCT). Compare the efficacy of a multimodal, opioid-free (OF) pain management pathway with a traditional opioid-containing (OC) pathway in patients undergoing anterior cervical procedures. Previous studies have compared opioid-based pain regimens to opioid-sparing regimens following cervical spine surgery, but have been limited by high rates of crossover, retrospective designs, reliance on indwelling pain catheters, opioid utilization for early postoperative analgesia, and/or a lack of patient-reported outcome measures. This is a RCT in which patients were allocated to either an OF or OC perioperative pain management protocol. Eligible study participants included adult (age up to 18y) patients who underwent primary, 1-level or 2-level anterior cervical surgery [anterior cervical discectomy and fusion (ACDF), anterior cervical disc arthroplasty (ACDA), or hybrid (ACDF and ACDA at different levels)] for degenerative pathology. The primary outcome variable was subjective pain level at 24 hours postoperative. The final study cohort consisted of 50 patients (22 OF, 28 OC). Patients in the OF group reported lower median postoperative pain levels at 6 hours (4 for OF vs. 7 for OC; P =0.041) and 24 hours (3 for OF vs. 5 for OC; P =0.032). At 2-week and 6-week follow-up, pain levels were similar between groups. Patients in the OF group reported greater comfort at 12 hours (9 for OF vs. 5 for OC; P =0.003) and 24 hours (9 for OF vs. 5 for OC; P =0.011) postoperatively. Notably, there were no significant differences in patients' reported pain satisfaction, overall surgical satisfaction, or overall sense of physical and mental well-being. In addition, there were no significant differences in falls, delirium, or constipation postoperatively. A multimodal OF pain management pathway following anterior cervical surgery for degenerative disease results in statistically noninferior pain control and equivalent patient-reported outcome measures compared with a traditional OC pathway.