Status:
WITHDRAWN
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
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Opioid-use Disorder
Opioid Use Disorder, Mild
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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/naloxo...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04091009
Start Date
October 1 2019
End Date
December 1 2025
Last Update
December 31 2025
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