Clinical trial NCT03266445: Effect of Buprenorphine/Naloxone Continuation on Pain Control and Opioid Use
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Opioid-use Disorder
Pain, Acute
Surgery
Keywords: relapse
buprenorphine/naloxone
opioids
narcotics
post-surgical pain
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2017-08-30
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to be maintained on their daily dose of buprenorphine/naloxone or to have their buprenorphine/naloxone reduced to 8mg prior to surgery. Each group will have identical perioperative treatment plans. Primary outcome measured is pain scores following surgery.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Post-operative pain scores
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Postoperative opioid consumption
timeFrame: 24 hours, 48 hours and 72 hours after surgery
measure: Post-operative pain scores
timeFrame: 48 hours, 72 hours after surgery
measure: Presence, severity of substance abuse
timeFrame: 1 month after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Massachusetts General Hospital
name: Aurora Quaye, MD
role: PRINCIPAL_INVESTIGATOR
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