Effect of Standard of Care Reduced Dose Versus Full Dose Buprenorphine/Naloxone in the Perioperative Period on Pain and Opioid Use Disorder Symptoms
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 入组人数
- 76
- 主要终点
- Pain scores at 24 hours post-operative procedure
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Continue Group
Those who continue taking their standard dose of buprenorphine before, during and after surgery.
干预措施: Buprenorphine/naloxone (Drug)
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, you will be put back on your full dose of buprenorphine.
干预措施: Buprenorphine/naloxone (Drug)
结局指标
主要结局
Pain scores at 24 hours post-operative procedure
时间窗: 24 hours
Average pain scores at 24 hours post-op
次要结局
未报告次要终点
研究者
Yi Zhang, MD
Principal Investigator
Massachusetts General Hospital