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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorStanford University

About this trial

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

Eligibility criteria

Qualifiers

18 to 75 years of age

Able to speak, write, and read fluently in English

Scheduled for elective surgery at

Stanford University Medical Center,

Disqualifiers

Infection, tumor, or fracture at the operative site

Allergy or intolerance to tizanidine

Current use of tizanidine

Renal impairment (Creatinine Clearance [CrCl] < 25 ml/min)

Trial design

Treatments tested in this trial

  • Tizanidine
  • MI-Opioid Taper
  • Placebo
  • Enhanced Usual Care

Treatment groups

375 Participants
are divided into 3 treatment groups

Sponsors and collaborators