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

STUDY DESIGN: Randomized controlled trial (RCT).

OBJECTIVE: 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.

SUMMARY OF BACKGROUND DATA: 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.

METHODS: 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 18 y) 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).

RESULTS: 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.

CONCLUSIONS: 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.