CARES (Comprehensive Analgesic, Recovery, and Education Support) for Surgery Trial

Summary

The goal of this clinical trial is to learn whether a combined behavioral and pharmacologic intervention can help reduce opioid use, improve pain recovery, and prevent opioid misuse after surgery in adults undergoing elective surgery. The study includes adults aged 18 to 75 who have a history of long-term opioid use, defined as having access to opioids for 60 or more days within the 180 days before surgery. The main questions it aims to answer are: * Does Motivational Interviewing with guided opioid tapering plus tizanidine (MI-Opioid Taper + Tizanidine) help participants return to their preoperative opioid use level or stop opioids faster than Enhanced Usual Care (EUC)? * Does the intervention reduce the time to pain resolution and decrease the likelihood of opioid misuse after surgery compared to EUC? Researchers will compare MI-Opioid Taper + Tizanidine to MI-Opioid Taper with placebo and to EUC to see whether the intervention improves postoperative opioid and pain outcomes. Participants will: * Complete a phone assessment and baseline survey before surgery * Be randomly assigned 7-13 days after surgery to one of three groups: * MI-Opioid Taper + tizanidine (MTT) * MI-Opioid Taper + placebo (MTP) * Enhanced Usual Care (EUC) * Complete brief weekly phone or video visits with a study clinician for 6 weeks starting 14 days after surgery * Take a study medication (tizanidine or placebo) three times daily for 5 weeks (MTT and MTP groups only) * Complete weekly online surveys for 6 months, followed by monthly surveys until 12 months after surgery to track pain, opioid use, and related outcomes

Detailed Description

This is a Type 1 hybrid effectiveness-implementation, three-arm, parallel randomized controlled trial (RCT) evaluating a behavioral-pharmacologic intervention for postoperative opioid management in patients with preoperative long-term opioid use (LTOU). A total of 375 participants will be enrolled across four academic medical centers: * Stanford University Medical Center, * Harvard University- Brigham and Women's Hospital, * Wake Forest University- Atrium Health Wake Forest Baptist Medical Center, and * University of Kansas Medical Center. Eligible participants will be randomized in equal allocation to one of three study conditions: * Motivational Interviewing-Guided Opioid Taper combined with tizanidine (MI-Opioid Taper + Tizanidine), * MI-Opioid Taper with placebo, or * Enhanced Usual Care (EUC). Participants will be followed for 12 months following surgery, with structured assessments of opioid use, pain outcomes, and related behavioral and clinical measures. The primary endpoint is time to return to baseline opioid use. Secondary endpoints include time to opioid cessation, time to opioid dispensing cessation, time to pain cessation, and incidence of postoperative opioid misuse. Additional exploratory analyses will examine behavioral and clinical mediators of treatment effects, including motivation for change, change talk, and pain reduction. Effect modification analyses will assess whether baseline participant characteristics are associated with differential treatment engagement and outcomes. Implementation outcomes will be evaluated using a mixed-methods approach guided by the RE-AIM framework, focusing on barriers and facilitators to future dissemination and scalability of the MI-Opioid Taper intervention. This project addresses a critical gap in postoperative care for patients with long-term opioid use in need of precision postoperative pain care to minimize opioid-related harms.

Eligibility Criteria

Interventions