Effects of Preoperative Gabapentin Versus Pregabalin on Shoulder Pain After Laparoscopic Cholecystectomy. A Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Post operative shoulder pain
研究概览
简要总结
The aim of this study is to evaluate the effect of premedication with pregabalin or gabapentin versus placebo on postoperative shoulder pain after laparoscopic cholecystectomy.
详细描述
Preoperative premedication with gabapentins reduces preoperative anxiety, stress response to surgical stimuli, decreases anesthetic use. The incidence of postoperative nausea and vomiting appears to be decreased. The other desired effect of gabapentins is the reduction in the intensity of postoperative pain after laparoscopic 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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •uncomplicated laparoscopic cholecystectomy
- •American Society of Anesthesiologists (ASA) status < 3
排除标准
- •acute cholecystitis
- •conversion to open cholecystectomy
- •history of epilepsia, psychiatric disorders and cognitive impairment
- •Pregnancy and breastfeeding
- •allergy to pregabalin and/or gabapentin
- •Chronic pain
- •Chronic medication by corticosteroids, neuroleptics or non steroidal anti inflammatory drugs
研究组 & 干预措施
placebo
Patients receive 2 capsules as placebo 2 hours before anesthesia. The capsules are delivered by the hospital pharmacy.
干预措施: Placebo oral capsule (Drug)
pregabalin
patients receive 2 capsules of pregabalin (pregabalin 75), two hours before anesthesia.
干预措施: Pregabalin 75mg (Drug)
gabapentin
patients receive 2 capsules of gabapentin (gabapentin 300), two hours before anesthesia.
干预措施: Gabapentin 300mg (Drug)
结局指标
主要结局
Post operative shoulder pain
时间窗: VAS score with rest at 2h, 6h, 12h, 24h and 48 hours after surgery
Primary outcome is the intensity of shoulder pain during the first 48 hours after laparoscopic cholecystectomy using the visual analog scale (VAS).
次要结局
- remifentanil consumption during anesthesia(one hour after tracheal tube removal)
- Post operative sleep quality during the first night(first night after surgery)
- Post operative nausea and vomiting(2, 6, 12, 24 and 48 hours after surgery.)
研究者
Mohamed Said NAKHLI
MD, anesthesia and intensive care
Faculty of Medicine, Sousse