A Prospective, Randomized Trial of the Effect of Buprenorphine Continuation Versus Dose Reduction on Pain Control and Post-Operative Opioid Use
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- MaineHealth
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Post-operative Pain Scores: 24 Hours After Surgery
研究概览
简要总结
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.
详细描述
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.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)
研究组 & 干预措施
Buprenorphine Dose Reduction
Patients instructed to reduce buprenorphine to 8mg prior to surgery
干预措施: Buprenorphine (Drug)
Buprenorphine Full Dose Continuation
Patients instructed to continue taking the full prescribed dose of buprenorphine.
干预措施: Buprenorphine (Drug)
结局指标
主要结局
Post-operative Pain Scores: 24 Hours After Surgery
时间窗: 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)
Post-operative Pain Scores: 48 Hours After Surgery
时间窗: 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)
Post-operative Pain Scores: 72 Hours After Surgery
时间窗: 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)
次要结局
- Opioid Relapse(30 days following surgery)
- Opioid Consumption(3 days post-op)
- Opioid Dispensing(30 days following surgery)
- Opioid Withdrawal(1-3 hours prior to surgery)
- Opioid Cravings(30 days following surgery)
- Opioid Misuse(30 days following surgery)