A Prospective, Randomized Trial of the Effect of Standard of Care Reduced Dose Versus Full Dose Buprenorphine/Naloxone in the Perioperative Period on Pain Control and Post-Operative Opioid Use Disorder Symptoms

Overview

The purpose of this research study is to compare two ways of managing pain in people who are taking buprenorphine and are scheduled to undergo surgery. Buprenorphine (subutex) and buprenorphine/naloxone (suboxone) are effective long-term treatments for substance use disorders. The management of pain after surgery in adults taking buprenorphine can be challenging, as buprenorphine may interfere with the effectiveness of other medications used to treat pain.

We want to compare how well pain is managed after surgery ("post-op") in two groups:

The "Continue Group": those who continue taking their standard dose of buprenorphine before, during and after surgery.

The "Reduce Group": those who are placed on a lower dose of buprenorphine starting one day before surgery and during the time period after surgery until the pain from the surgery has decreased. Once the pain from the surgery has decreased, you will be put back on your full dose of buprenorphine.

We also want to find out if there is a difference in pain, opioid cravings, and relapse rates in the month following surgery.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2022

Interventions

  • Drug: Buprenorphine
    • Participants will be randomly assigned to be maintained on their daily dose of buprenorphine or to have their buprenorphine reduced to 16mg on the day before surgery. Participants in the reduced group will then be prescribed 8mg buprenorphine daily from the day of surgery until transitioned back to their regular dose of buprenorphine when postoperative surgical pain has subsided
  • Drug: Buprenorphine/naloxone
    • Participants will be randomly assigned to be maintained on their daily dose of buprenorphine/naloxone or to have their buprenorphine/naloxone reduced to 16mg on the day before surgery. Participants in the reduced group will then be prescribed 8mg buprenorphine daily from the day of surgery until transitioned back to their regular dose of buprenorphine when postoperative surgical pain has subsided

Arms, Groups and Cohorts

  • Active Comparator: Continue Group
    • Those who continue taking their standard dose of buprenorphine before, during and after surgery.
  • Active Comparator: Reduce Group
    • Those who are placed on a lower dose of buprenorphine starting one day before surgery and during the time period after surgery until the pain from the surgery has decreased. Once the pain from the surgery has decreased, you will be put back on your full dose of buprenorphine.

Clinical Trial Outcome Measures

Primary Measures

  • Pain scores at 24 hours post-operative procedure
    • Time Frame: 24 hours
    • Average pain scores at 24 hours post-op

Participating in This Clinical Trial

Inclusion Criteria

  • American Society of Anesthesiologists (ASA) health class I-III
  • Currently taking buprenorphine or buprenorphine/naloxone daily at a dose of at least 16mg per day for at least the prior 30 days for treatment of Opioid Use Disorder by Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria
  • Scheduled for surgery at Massachusetts General Hospital where greater than 3/10 pain is expected on post-operative day 1

Exclusion Criteria

  • Participants unable to consent to the study
  • Renal insufficency with a glomerular filtration rate <30ml/min (participants would be unable to use ketorolac which is a part of the multimodal anesthetic plan)
  • Liver cirrhosis with a Model for End-Stage Liver Disease (MELD) score > 25 (participants would be unable to use Tylenol which is part of the multimodal anesthetic plan)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Massachusetts General Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Yi Zhang, MD, Principal Investigator – Massachusetts General Hospital
  • Overall Official(s)
    • Zhang Yi, MD PhD, Principal Investigator, Massachusetts General Hospital
  • Overall Contact(s)
    • Yi Zhang, 6177246102, mghpainresearch@partners.org

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