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

Abstract

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

Opioid-Free Analgesia is Safe and Effective in Anterior Cervical Spine Surgery

“…The decision to perform ACDF, ACDA, or a hybrid procedure was based on patient-specific and surgeon-specific factors. Baseline patient characteristics were obtained at the preoperative screening visit, including sex, age, body mass index, current prescription opioid consumption, history of nicotine use, history of depression, Charlson comorbidity index, central sensitization inventory (CSI), subjective pain level [based on 0–10 numeric rating scale (NRS)], Resilience Scale-5 (RS-5) questionnaire, constipation [based on the validated patient assessment of constipation symptoms (PAC-SYM) score], overall physical and mental well-being [based on Veterans Rand 12-item health survey (VR-12), including physical and mental component scores (PCS and MCS, respectively)], and creatinine 23,24 …”

“…The primary outcome variable was the subjective pain level experienced by patients at 24 hours postoperatively, which was measured on a 0–10 NRS that has been previously validated for present-moment subjective pain 24,26 . Secondary postoperative outcome variables included total morphine milligrams equivalents (MME) during hospitalization and at 2-week and 6-week follow-up; fall(s) at any time point after surgery (based on binary “yes” or “no” responses to the prompt, “Have you experienced a fall?”); subjective pain level (based on 0–10 NRS) at 6 and 12 hours postoperative, as well as at 2-week and 6-week follow-up; delirium (based on “yes” or “no” responses by floor nursing staff after postoperative administration of the Confusion Assessment Method delirium screening tool) at 6, 12, and 24 hours postoperative; patient comfort (based on 0–10 NRS) at 6, 12, and 24 hours postoperative; overall satisfaction with pain management (based on binary “yes” or “no” responses to the prompt, “Are you satisfied with your pain control?”) at 2-week and 6-week follow-up; presence of medication side effects such as constipation (based on binary “yes” or “no” responses to the question, “Are you having any constipation?”, as well as based on PAC-SYM score) at 2-week and 6-week follow-up; overall physical and mental well-being (based on VR-12, including PCS and MCS) at 2-week and 6-week follow-up; and overall satisfaction with surgical experience (based on 0–10 NRS) at 6-week follow-up.…”

“…assessment of constipation symptoms (PAC-SYM) score], overall physical and mental well-being [based on Veterans Rand 12-item health survey (VR-12), including physical and mental component scores (PCS and MCS, respectively)], and creatinine. 23,24 Before obtaining consent for participation, each prospective study participant received standardized education in the form of a prerecorded 5-minute video by the principal investigator on the purpose and general methods of the study, including specific education on opioids, their role in the perioperative period, and potential risks associated with their use. Additional general education about the study was also provided to each patient by individual investigators and research coordinators before patient consent.…”

“…The primary outcome variable was the subjective pain level experienced by patients at 24 hours postoperatively, which was measured on a 0-10 NRS that has been previously validated for present-moment subjective pain. 24,26 Secondary postoperative outcome variables included total morphine milligrams equivalents (MME) during hospitalization and at 2-week and 6-week follow-up; fall(s) at any time point after surgery (based on binary "yes" or "no" responses to the prompt, "Have you experienced a fall? "); subjective pain level (based on 0-10 NRS) at 6 and 12 hours postoperative, as well as at 2-week and 6-week follow-up; delirium (based on "yes" or "no" responses by floor nursing staff after postoperative administration of the Confusion Assessment Method delirium screening tool) at 6, 12, and 24 hours postoperative; patient comfort (based on 0-10 NRS) at 6, 12, and 24 hours postoperative; overall satisfaction with pain management (based on binary "yes" or "no" responses to the prompt, "Are you satisfied with your pain control?")…”

Acute Perioperative Pain Management of the Orthopaedic Patient

“…Patients who have been prescribed opioid pain medication during the 6-month period before surgery have a significantly greater incidence of prolonged use and greater mean opioid dose (Rosenthal et al, 2019). Appropriate potential candidates for opioid-free orthopaedic surgery are opioid naïve patients with normal hepatic and renal function, without allergies to NSAIDs and acetaminophen, or history of gastrointestinal bleeding or ulcers (Shing et al, 2021).…”