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

Phase 4

• Conditions: Opioid-use Disorder; Opioid Use Disorder, Mild
• Interventions: Drug: Buprenorphine; Drug: Buprenorphine/naloxone

• Registration Number: NCT04091009
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-09
• Study First Submitted: 2019-09-13
• Study First Submitted QC: 2019-09-13
• Last Update Submitted: 2019-09-13
• Study First Posted: 2019-09-16
• Last Update Posted: 2019-09-16
• Study Start: 2020-01
• Primary Completion: 2022-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 76

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reduce Group	Buprenorphine/naloxone	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.
Continue Group	Buprenorphine/naloxone	Those who continue taking their standard dose of buprenorphine before, during and after surgery.
Continue Group	Buprenorphine	Those who continue taking their standard dose of buprenorphine before, during and after surgery.
Reduce Group	Buprenorphine	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.

Primary Outcome Measures

Name	Time	Method
Pain scores at 24 hours post-operative procedure	24 hours	Average pain scores at 24 hours post-op