ANALGESIC EFFICACY OF LOW DOSE SPINAL BUPIVACAINE WITH FENTANYL FOR LAPAROSCOPIC HERNIA REPAIR ?A RANDOMIZED CONTROLLED STUDY
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1) Incidence of pain after laparoscopic hernia repair2)Intra- and post operative opioid sparing effect of low dose spinal anesthesia3)Quality of recovery -effect of low dose spinal anesthesia
研究概览
简要总结
This is a randomized, prospective, placebo controlled, parallel group study comparing general anesthesia alone with general anesthesia and 'add on' low dose spinal anesthesia in patients undergoing laparoscopic hernia repair.The primary outcome measures will be intra operative and post operative fentanyl sparing effect of spinal anesthesia, and effect on quality of recovery.Secondary outcome measures will be intra operative hemodynamic stability and post operative nausea and vomiting.Patients will be followed for 24 hours post operatively.All patients will have access to a patient-controlled analgesia (PCA) device which they can activate to get bolus doses of IV fentanyl.
研究设计
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
入选标准
- •(i) Adult males,Age 20 ?
- •65 years(ii) Unilateral or bilateral reducible inguinal herniae(iii) Scheduled for Total Extra Peritoneal (TEP) repair under geneal anesthesia.
排除标准
- •(i) Uncontrolled systemic illness(ii) Neurological illness (Parkinsonism, h/o CVA) (iii) Any contraindications to spinal anaesthesia (local infection, coagulopathy, documented anatomical abnormality, allergy to local anaesthetic agents)(iv) Patients undergoing Trans Abdominal Pre Peritonal(TAPP)repair(v) Irreducible herniae(vi) Patients with other surgical procedures performed concurrently(vii) Patient refusal for the study.
结局指标
主要结局
1) Incidence of pain after laparoscopic hernia repair2)Intra- and post operative opioid sparing effect of low dose spinal anesthesia3)Quality of recovery -effect of low dose spinal anesthesia
时间窗: Post operatively, 6 hourly, for 24 hours
次要结局
- 1) Intra operative hemodynamic stability2) Post operative nausea and vomiting3) Side effects related to sub arachnoid block(Intra operative and up to 24 hours post operatively)