A Randomized Placebo-Controlled Study of Whether Pre-operative Pregabalin 300 mg Will Improve Pain Control in Patients Undergoing Laparoscopic Roux-en-Y Gastric Bypass (Bariatric Surgery)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Post-operative Pain Medication Requirements
研究概览
简要总结
Randomized clinical trial to evaluate whether a single pre-operative dose of Pregabalin will alleviate post-operative pain and decrease post-operative analgesic requirements in morbidly obese patients undergoing laparoscopic gastric bypass surgery.
详细描述
Pregabalin is a popular adjunct for relieving neuropathic pain in diabetics. There have been multiple studies evaluating its use in pre and post-operative pain control in various surgeries. Post-operative pain control is a challenging problem in bariatric patients due to the high doses of narcotic required, related to the high body mass, and the danger of concomitant respiratory depression. In the obese patient, the goal of postoperative pain management is provision of comfort, early mobilization and improved respiratory function, without causing inadequate pain control, respiratory compromise or increased nausea.
Methods: A Randomized Controlled Trial, whereby patients undergoing Laparoscopic Roux-en-Y gastric bypass will be administered a single pre-operative dose of Pregabalin or a placebo. We plan to follow their immediate post-operative course in the hospital, with regard to the following primary endpoints:
- Post-operative analgesic requirements
- Post-operative pain scale (rated 0-10)
- Episodes of vomiting
- Post-operative antiemetic requirement
- Length of stay
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing laparoscopic Roux-en-Y gastric bypass surgery.
排除标准
- 未提供
研究组 & 干预措施
Pregabalin
Single, 300 mg pre-operative oral dose of Pregabalin.
干预措施: Pregabalin (Drug)
Sugar Pill
Single, placebo pre-operative dose.
干预措施: Placebo (for Pregabalin) (Drug)
结局指标
主要结局
Post-operative Pain Medication Requirements
时间窗: Morphine milligram equivalent opioid requirements on post op days zero, 1, and 2.
次要结局
- Length of Stay(Days in hospital following surgical procedure, up to 5 days)
研究者
Valerie Halpin
Principal Investigator
Legacy Health System