Randomized Prospective Study Comparing Variable Gabapentin Dosages for Postoperative Analgesia Following Open Thoracotomy
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores.
研究概览
简要总结
Gabapentin is a nerve medication that treats pain. The specific aim of the study is to compare the difference in the postoperative use of no gabapentin, 300 mg gabapentin 3x daily, or 300 mg gabapentin once at night. Our hypothesis is that higher doses of gabapentin will correlate with decreased pain at the incision and chest tube sites and decreased opioid consumption.
详细描述
The purpose of this study is to determine the effectiveness of various dosages of gabapentin, as part of an ERAS protocol, for postoperative analgesic control after open thoracotomy and additionally determine if there is a correlation of the dosage of gabapentin with pulmonary complication and impaired cognition postoperatively.
Given the widespread use of gabapentin and the huge variability in dosing, our study aims to simplify ERAS protocols for thoracotomy by figuring out the optimal dosing of gabapentin and whether its use overall decreases postoperative opioid consumption and complications.
The specific aim of the study is to compare the difference in the postoperative use of no gabapentin, 300 mg gabapentin 3x daily, or 300 mg gabapentin once at night.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
300 mg Gabapentin 3X per day
Patients will receive 300mg gabapentin 3x a day after open thoracotomy
干预措施: Gabapentin (Drug)
300 mg Gabapentin once per day at night
Patients will receive 300mg gabapentin once a day at night after open thoracotomy
干预措施: Gabapentin (Drug)
结局指标
主要结局
The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores.
时间窗: 96 hour after surgery
The pain scores will be collected at incision and chest tube. It will be measured by the study team investigator using a Visual Analog Scale (VAS) using a scale of documentation 0-10 for 10 being the worst pain and 0 being no pain.
次要结局
- Pulmonary Complications(As they occur up to 96 hours after surgery.)
- Sedation Scores(96 hour after surgery.)
- Opioid Usage(96 hour after surgery.)
- Time to First Opioid Request(As it first occurs, up to 96 hours after surgery)
- Delirium(96 hours after surgery.)
- Visual Disturbance(96 hours after surgery.)
- Incidence of Falls(As they occur up to 96 hours after surgery.)
- Dizziness(96 hours after surgery.)
- Hospital Length of Stay(From the date of surgery to date of hospital discharge (up to 24 days))
研究者
Yar Yeap
Associate Professor of Clinical Anesthesiology
Indiana University