Baclofen as a Perioperative Analgesic Adjuvant
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Postoperative Opioid Requirements
研究概览
简要总结
The purpose of this study is to determine whether a single, oral dose of baclofen alters postoperative opioid requirements.
详细描述
Postoperative pain continues to be a significant clinical problem. Use of perioperative adjuvants has improved postoperative pain control. The GABA-B receptor agonist, baclofen, is an appropriate drug to trial as such an analgesic adjuvant. Therefore, the investigators will conduct a study designed to determine whether or not a single, oral dose of baclofen given to patients undergoing kidney stone surgery will reduce postoperative opioid requirements measured in the first 24 hours 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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (age >= 19 y.o.) scheduled for kidney stone-related surgery
排除标准
- •History of allergy to baclofen
- •Any condition which might limit appropriate report and treatment of postoperative pain (e.g., non-English speaking; severe psychiatric disease)
研究组 & 干预措施
Opioid Tolerant - baclofen
Patients identified as opioid tolerant if they reported using daily opioids greater than one month. Randomized into baclofen (10 mg p.o.) group. Drug was given within 30 minutes of OR entry. Although pseudo-randomization was planned to be initiated near the end of the trial in order to assure balance group numbers, the early termination of the study did not require this and so all randomized to either baclofen or placebo, independent of opioid status.
干预措施: Baclofen 10mg (Drug)
Opioid Tolerant - placebo
Patients identified as opioid tolerant if they reported using daily opioids greater than one month. Randomized into placebo group with dummy pill administration. Pill was given within 30 minutes of OR entry.Although pseudo-randomization was planned to be initiated near the end of the trial in order to assure balance group numbers, the early termination of the study did not require this and so all randomized to either baclofen or placebo, independent of opioid status.
干预措施: Placebo (Other)
Opioid Naive - baclofen
Patients identified as opioid naive if they reported minimal preoperative use of opioids with a criteria of non-daily use and/or use less than one month. Randomized into baclofen (10 mg p.o.) group. Drug was given within 30 minutes of OR entry.Although pseudo-randomization was planned to be initiated near the end of the trial in order to assure balance group numbers, the early termination of the study did not require this and so all randomized to either baclofen or placebo, independent of opioid status.
干预措施: Baclofen 10mg (Drug)
Opioid Naive - placebo
Patients identified as opioid naive if they reported minimal preoperative use of opioids with a criteria of non-daily use and/or use less than one month. Randomized into placebo group with dummy pill administration. Pill was given within 30 minutes of OR entry.Although pseudo-randomization was planned to be initiated near the end of the trial in order to assure balance group numbers, the early termination of the study did not require this and so all randomized to either baclofen or placebo, independent of opioid status.
干预措施: Placebo (Other)
结局指标
主要结局
Postoperative Opioid Requirements
时间窗: From 0 hours post-operatively to 24 hours post-operatively
Patients Patients' opioid requirements for acceptable pain control will be assessed based on the total oral morphine equivalent needed for post operative pain control.
次要结局
未报告次要终点
研究者
Timothy Ness, MD
Prinicipal Investigator
University of Alabama at Birmingham