Administration of Pre-Operative Gabapentin to Patients Undergoing Laparoscopy: A Prospective Double-blinded, Placebo Controlled Randomized Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- NRS (Numerical Rating Scale)
研究概览
简要总结
The purpose of this study is to prospectively determine the influence of immediate pre-operative gabapentin administration on acute postoperative pain. The investigators hypothesize that immediate post-operative pain will be improved with pre-operative administration of gabapentin.
详细描述
The purpose of this study is to prospectively determine the influence of immediate pre-operative gabapentin administration on acute postoperative pain. We hypothesize that immediate post-operative pain will be improved with pre-operative administration of gabapentin.
We plan to conduct a prospective randomized trial to assess the effect of a single immediate pre-operative dose of gabapentin 300mg on immediate post-operative pain in patients undergoing laparoscopy for gynecologic indications. This concept has been studied in patients undergoing abdominal hysterectomy. We aim to study the effect on patients undergoing laparoscopy.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •The patient must be female and planning to have a laparoscopic or robotic assisted procedure for benign gynecologic indications.
- •Patients must be treated in the department of Obstetrics and Gynecology in the division of Minimally Invasive Gynecologic Surgery.
- •The patient must be in the age range of 18-80 years, in general good health and able to comply with study procedures.
排除标准
- •Male patients will be excluded from this study.
- •Patients under 18 years old will be excluded from this study.
- •Pregnant patients. All patients will have a routine pre-operative urine HCG to exclude pregnancy.
- •Patients having abdominal, vaginal or hysteroscopic procedures
- •Allergy to gabapentin
- •Chronic use of gabapentin (greater than 6 months)
研究组 & 干预措施
Drug 1
Patients will receive Gabapentin 300mg tab less than 1 hour before surgery.
干预措施: Gabapentin (Drug)
Drug 2
Patients will receive Methylcellulose based placebo tab less than 1 hour before surgery.
干预措施: Placebo (Other)
结局指标
主要结局
NRS (Numerical Rating Scale)
时间窗: 2-8 hours
The NRS is a numerical scale ranging from 0-10 implemented with adults. Having no pain is rated as a 0 and the worst pain the patient could tolerate is rated as a 10.
次要结局
- VAS (Visual Analog Scale)(2 -6 hours)
- Total Morphine Consumption(12 hours post-operatively)
研究者
Timothy A Deimling
Principal Investigator; Minimally Invasive Gyn Surgery Fellow
Milton S. Hershey Medical Center