Assess the Efficacy of Buprenorphine/Naloxone Micro-Dosing for Postoperative Pain Management in Opioid-Tolerant Patients
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Postoperative Pain Scores
研究概览
简要总结
A randomized clinical study evaluating the effect of buprenorphine/naloxone (bup/nx) sublingual film on postoperative pain management in opioid-tolerant patients.
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
- •Opioid tolerance, defined as the daily use of greater than or equal to 60mg of oral morphine or an equianalgesic dose of any other opioid for more than 7 days immediately prior to the surgery
- •Undergoing orthopedic or general surgery
- •18 years of age or older
- •Willing and able to adhere to the study protocol and follow-up schedule
- •Able to provide written informed consent to participate in the clinical trial
- •If female and of childbearing potential, agree to use an effective method of birth control approved by the study investigators throughout the study
排除标准
- •Buprenorphine or buprenorphine/naloxone use in the last two weeks
- •Patients receiving pre-, intra-, or post-operative regional blocks or neuraxial anesthesia
- •Patients receiving postoperative ketamine or lidocaine boluses or infusions
- •Patients receiving postoperative nonsteroidal anti-inflammatory drugs (NSAIDs) for pain control
- •Diagnosis of severe medical or psychiatric conditions contraindicated for bup/nx treatment
- •Liver disease, including clinically significant transaminitis, active hepatitis infection, cirrhosis with evidence of impaired synthetic function
- •Anticipated deterioration of health due to discontinuation of medications that are contraindicated with bup/nx
- •Positive pregnancy test for women of childbearing potential
- •Known allergy or sensitivity to bup/nx
- •Anticipation that the subject may need to initiate pharmacological treatment during the trial that is deemed unsafe by the study physician or could prevent study completion
- •Current participation in additional pharmacologic research study
- •Active suicidal ideation as determined by PI or study clinician
研究组 & 干预措施
Buprenorphine/Naloxone
Subjects will take a maximum dose of 4 mg buprenorphine and 1 mg naloxone with concurrent administration of other intravenous or oral opioids needed.
干预措施: Buprenorphine/Naloxone (Drug)
Standard Medication Regiment
Subjects will take conventional intravenous or oral opioid management.
结局指标
主要结局
Postoperative Pain Scores
时间窗: through study completion, an average of 6 days
To examine changes in pain scores daily from the day of surgery to the hospital discharge day.
Postoperative Opioid Consumption
时间窗: through study completion, an average of 6 days
To compare opioid consumption after surgery between the buprenorphine/naloxone group and the standard medication regiment group.
Length of Hospital Stay
时间窗: through study completion, an average of 6 days
To compare the length of hospital stay after surgery between the buprenorphine/naloxone group and the standard medication regiment group.
次要结局
未报告次要终点
研究者
Yi Zhang, MD
Principal Investigator
Massachusetts General Hospital