A Controlled Randomized Trial Comparing Spinal Versus General Anesthesia for Transabdominal Preperitoneal (TAPP) Repair of Inguinal Hernia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Postoperative opioid consumption
研究概览
简要总结
The purpose of the study is to assess whether spinal anesthesia is superior to the standard general anesthesia or not for patients undergoing transabdominal preperitoneal inguinal hernia repair (TAPP).
详细描述
Anesthesia for laparoscopic procedures, including transabdominal preperitoneal inguinal hernia repair(TAPP) is synonymous with general anesthesia because of the adverse effects of the CO2 pneumoperitoneum on the awake patient, and regional anesthesia is preferred only in patients where general anesthesia is contraindicated. Α pilot study of our hospital has recently shown the feasibility to perform successfully and safely transabdominal preperitoneal inguinal hernia repair with low pressure CO2 pneumoperitoneum under spinal anesthesia.After this pilot study and based on previous experience in regional anesthesia for laparoscopic procedures, we designed a controlled randomized trial in order to compare spinal anesthesia with the standard general anesthesia for patients undergoing transabdominal preperitoneal inguinal hernia repair (TAPP).
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA physical status I-III
- •Normal coagulation profile
排除标准
- •Non-reducible/obstructed hernias
- •Previous open surgery in the lower abdomen
- •Contraindication for pneumoperitoneum
- •Contraindication for spinal or/and general anesthesia
- •History of chronic pain or daily intake of analgesics
- •Psychiatric disorders
- •Inability of patients to use PCA pump
结局指标
主要结局
Postoperative opioid consumption
时间窗: Every 8 hours
The total dose of morphine was calculated as mg and administered by PCA pump
次要结局
- Quality of life(6 months after the operation)
- Patient satisfaction(2 weeks after the operation)
- Complications(1 year)
- Postoperative pain(Every 8 hrs)
- Side- effects(Every 8 hrs)
- Hospital stay(Patients will be followed for the duration of hospital stay)
- Chronic Pain(12 months after the operation)
研究者
Chamaidi Sarakatsianou
RN,MSc
Larissa University Hospital