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

Effect of Standard of Care Reduced Dose Versus Full Dose Buprenorphine/Naloxone in the Perioperative Period on Pain and Opioid Use Disorder Symptoms

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04091009

Enrollment

Registered

2019-09-16

Start date

2019-10-31

Completion date

2025-12-31

Last updated

2025-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid-use Disorder, Opioid Use Disorder, Mild

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. 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.

Interventions

DRUGBuprenorphine/naloxone

Participants will 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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)

Design outcomes

Primary

Measure	Time frame	Description
Pain scores at 24 hours post-operative procedure	24 hours	Average pain scores at 24 hours post-op

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026