The Effect of Buprenorphine Continuation for Patients With Opioid Use Disorder

Study Overview
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Brief Summary
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There is limited guidance on the optimal management of buprenorphine perioperatively and both buprenorphine discontinuation and continuation are acceptable standards of care. Buprenorphine continuation at low analgesic dosing is also accepted, however is not provided as a potential treatment strategy by the Substance Abuse and Mental Health Services Administration (SAMHSA). There is the risk of inadequate pain control necessitating opioid escalation when buprenorphine is continued. Preliminary clinical observations support buprenorphine continuation at low analgesic doses (8mg) as it adequately facilitates postoperative pain management without interrupting opioid use disorder (OUD) treatment, however to date, no prospective trial has investigated this treatment strategy in comparison to full dose buprenorphine continuation. Since optimal perioperative dosing strategies remain unknown, the purpose of this study is to investigate if buprenorphine continuation at analgesic dosing is superior to full dose buprenorphine continuation in individuals presenting for elective surgery.

Detailed Description
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The purpose of this study is to investigate whether buprenorphine continuation at analgesic dosing is superior to full dose buprenorphine continuation in individuals presenting for elective surgery. Adults scheduled for elective surgery who are taking ≥12mg buprenorphine for OUD treatment will be eligible for this study. Enrolled participants will be randomized to receive either a reduced analgesic dose of buprenorphine (8mg) or to continue buprenorphine on the day of surgery without dose reduction. The primary outcome of interest is postoperative pain scores. The secondary outcomes of interest are opioid consumption, opioid dispensing up to 30 days following the surgical procedure and OUD related symptoms, including opioid withdrawal, cravings and relapse. The investigators hypothesis is that there will be a clinically significant increase in pain scores when buprenorphine is continued in full compared to when it is continued at a lower analgesic dose. Clinical significance will be defined as a difference in composite pain scores of greater than 20% between groups. The investigators also hypothesize that opioid consumption and opioid dispensing will be greater with full dose buprenorphine continuation compared to low-dose continuation.

Official Title
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A Prospective, Randomized Trial of the Effect of Buprenorphine Continuation Versus Dose Reduction on Pain Control and Post-Operative Opioid Use

Conditions
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Opioid-use Disorder

Intervention / Treatment
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* Drug: Buprenorphine
* Drug: Buprenorphine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18 and older American Society of Anesthesia health class I-III Currently taking buprenorphine formulation equivalent to 12mg or greater for at least 30 days for treatment of Opioid Use Disorder Scheduled for surgery at Maine Medical Center for a procedure with a greater than 4/10 pain intensity is expected on post-op day one. Exclusion Criteria: unable to consent to the study currently pregnant current major medical illness that could limit the ability to utilize medications within our protocol driven multimodal analgesic plan (e.g. cancer, severe end-stage organ disease, or dementia)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Buprenorphine Dose Reduction<br>Patients instructed to reduce buprenorphine to 8mg prior to surgery | Drug: Buprenorphine<br>* Patients randomized to this group will reduce their buprenorphine dose prior to surgery.<br>|
| Other: Buprenorphine Full Dose Continuation<br>Patients instructed to continue taking the full prescribed dose of buprenorphine. | Drug: Buprenorphine<br>* Patients randomized to this group will continue their buprenorphine at the full prescribed dose.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative pain scores: 24 hours after surgery | Highest, average, and lowest pain scores will be evaluated using the Numerical Rating Scale of 0 (no pain) -10 (worst pain) | 24 hours after surgery | 
| Post-operative pain scores: 48 hours after surgery | Highest, average, and lowest pain scores will be evaluated using the Numerical Rating Scale of 0 (no pain) -10 (worst pain) | 48 hours after surgery | 
| Post-operative pain scores: 72 hours after surgery | Highest, average, and lowest pain scores will be evaluated using the Numerical Rating Scale of 0 (no pain) -10 (worst pain) | 72 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid consumption | All opioids consumed through 72 hours after surgery combined into mean morphine equivalents | 3 days post-op | 
| Opioid dispensing | All prescriptions filled for the patient in the Prescription Awareness Tool | 30 days following surgery | 
| Opioid Withdrawal | Measured by the Clinical Opioid Withdrawal Scale scores can range from 0-48 (5-12 mild; 13-24 moderate; 25-36 moderately severe; more than 36 severe withdrawal) | 30 days following surgery | 
| Opioid Cravings | Measured by the Opioid Craving Scale (scale ranges from 0-30 with higher scores indicating higher levels of cravings) | 30 days following surgery | 
| Opioid Misuse | Measured by the Current Opioid Misuse Measure (scores can range from 0-68, scores of 9 or lower indicates a low risk of opioid misuse or abuse, scores higher than 9 indicate a high risk). and a 30-day Timeline Followback that will ask patients to report instances of opioid use for the 30 days after surgery | 30 days following surgery | 
| Opioid Relapse | Measured by a 30-day Timeline Followback that will ask patients to report instances of opioid use for the 30 days after surgery. | 30 days following surgery |