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Clinical Trials/NCT03266445
NCT03266445
Unknown
Phase 4

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

Massachusetts General Hospital0 sites76 target enrollmentOctober 5, 2018

Overview

Phase
Phase 4
Intervention
buprenorphine/naloxone
Conditions
Opioid-use Disorder
Sponsor
Massachusetts General Hospital
Enrollment
76
Primary Endpoint
Post-operative pain scores
Last Updated
7 years ago

Overview

Brief Summary

The aim of this study is to determine the effect of continuation of buprenorphine/naloxone in patients with history of Opioid Use Disorder (OUD) scheduled for surgery compared to reduced dose buprenorphine/naloxone prior to surgery on pain scores, opioid consumption, depressive symptoms and severity of substance use dependence- including record of problematic use of any non-prescribed opioids, alcohol and illicit narcotics.

Detailed Description

Opioid use disorder (OUD) is characterized by non-remitting cycles of remission and opioid abuse relapse. It is associated with a high rate of psychiatric and physical co-morbidity when left untreated. Buprenorphine and buprenorphine/naloxone are effective opioid maintenance therapy (OMT) for OUD, however, treatment of acute post-surgical pain in patients taking buprenorphine is perceived to be challenging. Although not substantiated in clinical studies, the combination of high receptor binding affinity, long half-life, and partial mu opioid receptor agonism with buprenorphine/naloxone are thought to inhibit the analgesic actions of full mu opioid receptor agonists, potentially making standard postoperative pain control strategies less effective. There is no evidence based standard of care for optimal acute pain management strategies for patients taking buprenorphine and most recommendations are based upon provider opinion- occasionally conflicting along specialty lines. Some providers, mainly consisting of surgeons and anesthesiologists, recommend that buprenorphine should be discontinued at least 72 hours prior to elective surgery and replaced with low dose opioid agonists, in the interim. Other providers, mainly comprising of psychiatrists, contend that these patients should be maintained on buprenorphine throughout the peri-operative period at either a full or reduced dose to prevent an indeterminate risk of substance abuse relapse that can occur as consequence to the abrupt termination buprenorphine in the highly stressful surgical period. This study aims to inform this important unresolved question in the clinical care of this growing population. The investigators seek to determine the effectiveness of managing postoperative pain in patients with OUD where buprenorphine/naloxone is continued perioperatively compared to patients where buprenorphine/naloxone is reduced to a lower dose. Longitudinally, the investigators also intend to determine if there is a difference in substance abuse relapse in patients where buprenorphine/naloxone is continued vs. held by using self assessments and communication with the participant's buprenorphine provider.

Registry
clinicaltrials.gov
Start Date
October 5, 2018
End Date
February 26, 2022
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Aurora Naa-Afoley Quaye

Instructor M.D.

Massachusetts General Hospital

Eligibility Criteria

Inclusion Criteria

  • currently taking buprenorphine or buprenorphine/naloxone daily for treatment of opioid use disorder by DSM-V criteria
  • on buprenorphine or buprenorphine/naloxone dose of greater than 8mg for at least 30 days
  • ASA health class I-III

Exclusion Criteria

  • Unable to consent to the study
  • Significant pulmonary or cardiac disease
  • Renal insufficiency with a glomerular filtration rate less than 30ml/min
  • Liver cirrhosis with a Model for End-Stage Liver Disease (MELD) score of greater than 25

Arms & Interventions

FULL-BUPRENORPHINE

Participants will be randomly assigned to be maintained on their daily dose of buprenorphine/naloxone

Intervention: buprenorphine/naloxone

Outcomes

Primary Outcomes

Post-operative pain scores

Time Frame: 24 hours after surgery

Level of pain on a Visual Analog Scale of 0-100 (0=no pain; 100=worst pain imaginable) This scale will be used to quantify the varying degrees of pain or discomfort experienced by the participant.

Secondary Outcomes

  • Presence, severity of substance abuse(1 month after surgery)
  • Postoperative opioid consumption(24 hours, 48 hours and 72 hours after surgery)
  • Post-operative pain scores(48 hours, 72 hours after surgery)

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