Health TrialsbyHealthPanel

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

ConditionsChronic PainBack PainNeck PainOpioid Misuse
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Tizanidine

    Drug

    Tizanidine 2mg three times a day for 5 weeks after surgery

  • MI-Opioid Taper

    Behavioral

    Motivational Interviewing (MI) and guided Opioid Tapering support adapting MI principles for enhancing motivation to change in pain treatment and tailoring key MI tools to postoperative opioid use delivered through weekly phone calls from weeks 2 to 7, and at week 11. The guided opioid tapering protocol will be a 25% total daily opioid dose reduction every 7 days with opioid discontinuation 7 days after reaching 1 opioid pill per day.

  • Placebo

    Drug

    1 tablet three times a day for 5 weeks after surgery

  • Enhanced Usual Care

    Behavioral

    Participants will receive weekly phone calls from weeks 2 to 7, and at week 11. 1 topic per call will be reviewed in this sequence:1) standardized instructions on taking opioid medications after surgery, 2) safe opioid use, 3) avoiding medication errors, 4) local mental health resources and 988 Suicide \& Crisis lifeline, 5) disposal of unused medications, 6) prescription drug abuse, and 7) complementary health approaches for chronic pain. Education materials will be reviewed in a didactic style without a tailored discussion.

Treatment groups

375 Participants
are divided into 3 treatment groups
Group A: MI-Opioid Taper and tizanidineExperimental treatment 2 interventions
Group B: MI-Opioid Taper and placeboExperimental treatment 2 interventions
Group C: Enhanced Usual CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Time to Baseline Opioid Use

Defined as the first of two consecutive reports of return to preoperative daily MME or lower on the modified Brief Pain Inventory (mBPI) or the Recent Opioid Medication Use survey. Preoperative daily MME use is defined as average daily MME assessed during the Preoperative Call in the 1-5 day window prior to surgery.

Time frame
From Postoperative Day 7 through Postoperative Day 365

Secondary outcomes

1

Time to Complete Opioid Cessation

First of two consecutive reports of opioid cessation on the modified Brief Pain Inventory (mBPI) or the Recent Opioid Medication Use survey.

Time frame
From Postoperative Day 7 through Postoperative Day 365
2

Time to Opioid Dispensing Cessation

Via state Prescription Drug Monitoring Program (PDMP): First day in the first gap in opioid prescribing ≥ 30 days after surgery

Time frame
From Postoperative Day 7 through Postoperative Day 365

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stanford University

Lead sponsor

Source ClinicalTrials.gov
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