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.

Opioid-Free Analgesia Provides Pain Control Following Thumb Carpometacarpal Joint Arthroplasty.

BACKGROUND: We hypothesized that an opioid-free (OF), multimodal pain management pathway for thumb carpometacarpal (CMC) joint arthroplasty would not have inferior pain control compared with that of a standard opioid-containing (OC) pathway. METHODS: This was a single-center, randomized controlled clinical trial of patients undergoing primary thumb CMC joint arthroplasty. Patients were randomly allocated to either a completely OF analgesic pathway or a standard OC analgesic pathway. Patients in both cohorts received a preoperative brachial plexus block utilizing 30 mL of 0.5% ropivacaine that was administered via ultrasound guidance. The OF group was given a combination of cryotherapy, anti-inflammatory medications, acetaminophen, and gabapentin. The OC group was only given cryotherapy and opioid-containing medication for analgesia. Patient-reported pain was assessed with use of a 0 to 10 numeric rating scale at 24 hours, 2 weeks, and 6 weeks postoperatively. We compared the demographics, opioid-related side effects, patient satisfaction, and Veterans RAND 12-Item Health Survey (VR-12) results between these 2 groups. RESULTS: At 24 hours postoperatively, pain scores in the OF group were statistically noninferior to, and lower than, those in the OC group (median, 2 versus 4; p = 0.008). Pain scores continued to differ significantly at 2 weeks postoperatively (median, 2 versus 4; p = 0.001) before becoming more similar at 6 weeks (p > 0.05). No difference was found between groups with respect to opioid-related side effects, patient satisfaction, or VR-12 results. CONCLUSIONS: A completely opioid-free perioperative protocol is effective for the treatment of pain following thumb CMC joint arthroplasty in properly selected patients. LEVEL OF EVIDENCE: Therapeutic Level I . See Instructions for Authors for a complete description of levels of evidence.

Study protocol: randomized controlled trial of opioid-free vs. traditional perioperative analgesia in elective orthopedic surgery.

BACKGROUND: The medical community is beginning to recognize the contribution of prescription opioids in the growing national opioid crisis. Many studies have compared the safety and efficacy of alternative analgesics to opioids, but none utilizing a completely opioid-free perioperative protocol in orthopedics. METHODS: We developed and tested an opioid-free perioperative analgesic pathway (from preoperative to postoperative period) among patients undergoing common elective orthopedic procedures. Patients will be randomized to receive either traditional opioid-including or completely opioid-free perioperative medications. This study is being conducted across multiple orthopedic subspecialties in patients undergoing the following common elective orthopedic procedures: single-level or two-level ACDF/ACDA, 1st CMC arthroplasty, Hallux Valgus/Rigidus corrections, diagnostic knee arthroscopies, total hip arthroplasty (THA), and total shoulder arthroplasty/reverse total shoulder arthroplasty (TSA/RTSA). The primary outcome measure is pain score at 24 h postoperatively. Secondary outcome measures include pain scores at additional time points, medication side effects, and several patient-reported variables such as patient satisfaction, quality of life, and functional status. DISCUSSION: We describe the methods for a feasibility randomized controlled trial comparing opioid-free perioperative analgesics to traditional opioid-including protocols. We present this study so that it may be replicated and incorporated into future studies at other institutions, as well as disseminated to additional orthopedic and/or non-orthopedic surgical procedures. The ultimate goal of presenting this protocol is to aid recent efforts in reducing the impact of prescription opioids on the national opioid crisis. TRIAL REGISTRATION: The protocol was approved by the local institutional review board and registered with clinicaltrials.gov (Identifier: NCT04176783 ) on November 25, 2019, retrospectively registered.