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

Mass General Brigham

Status and phase: Withdrawn; Phase 4

Conditions: Opioid Use Disorder, Mild; Opioid-use Disorder

Treatments: Drug: Buprenorphine/naloxone

Study type: Interventional

Funder types: Other

Identifiers

NCT04091009

2019P001092

Details and patient eligibility

About

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.

The investigators 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, participants will be put back on their full dose of buprenorphine.

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

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

0 participants in 2 patient groups

Continue Group

Active Comparator group

Description:

Those who continue taking their standard dose of buprenorphine before, during and after surgery.

Treatment:

Drug: Buprenorphine/naloxone

Reduce Group

Active Comparator group

Description:

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.

Treatment:

Drug: Buprenorphine/naloxone