Comparison of Analgesic Efficacy of Ultrasound Guided Erector Spinae Plane Block With Port Site Infiltration Following Laparoscopic Cholecystectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Total postoperative opioid consumption.
研究概览
简要总结
To compare the efficacy of ultrasonography (USG)-guided bilateral Erector spinae plane block (ESPB) with port-site infiltration using bupivacaine for post-operative analgesia after laparoscopic cholecystectomy with a hypothesis that both Erector spinae plane block and port-site infiltration are effective in providing post-operative analgesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with the American Society of Anesthesiologists (ASA) physical status I/II,
- •Age between 18 and 60 years with a body mass index (BMI) of 18-35 kg/m2,
- •Patients scheduled for elective laparoscopic cholecystectomy.
排除标准
- •Allergy to local anaesthetics,
- •Infection at the site of injection,
- •, Coagulopathy,
- •Chronic pain syndromes,
- •Prolonged opioid medication,
- •Patients who received any analgesic 24 h before surgery
研究组 & 干预措施
Erector spinae plane block
ultrasound guided ESP Block after anaesthesia induction
干预措施: Erector spinae plane block (Procedure)
Erector spinae plane block
ultrasound guided ESP Block after anaesthesia induction
干预措施: Ultrasound machine (Mindray DP 9900 plus; Mindray Bio-Medical Electronics, Shenzhen, China) (Device)
Erector spinae plane block
ultrasound guided ESP Block after anaesthesia induction
干预措施: Bupivacaine 0.5% (Drug)
Erector spinae plane block
ultrasound guided ESP Block after anaesthesia induction
干预措施: Lidocaine 2% (Drug)
Port site infiltration technique
After the induction of anaesthesia, pre-incisional port-site infiltration will be performed by the same surgeon every time with 20 ml of Local anesthetic (LA) mixture that will be divided equally between port sites
干预措施: Port site infiltration (Procedure)
Port site infiltration technique
After the induction of anaesthesia, pre-incisional port-site infiltration will be performed by the same surgeon every time with 20 ml of Local anesthetic (LA) mixture that will be divided equally between port sites
干预措施: Bupivacaine 0.5% (Drug)
Port site infiltration technique
After the induction of anaesthesia, pre-incisional port-site infiltration will be performed by the same surgeon every time with 20 ml of Local anesthetic (LA) mixture that will be divided equally between port sites
干预措施: Lidocaine 2% (Drug)
结局指标
主要结局
Total postoperative opioid consumption.
时间窗: 24 hours postoperatively
Nalbuphine consumption in mg.(equivalent to morphine dose)
次要结局
- Pain scores;Numerical Rating Scale (NRS) at rest and when coughing(at 1, 2,4 , 8, 16 and 24 hours postoperatively.)
- •Cumulative postoperative analgesic consumption(24 hours postoperatively)
- •Heart Rate (HR)(Intraoperatively at 0, 5,10, 20, and 30 minutes. Then every 15 min thereafter till the end of surgery)
- •Mean Arterial Pressure (MAP)(Intraoperatively at 0, 5,10, 20, and 30 minutes. Then every 15 min thereafter till the end of surgery)
- Incidence and severity Postoperative nausea & vomiting (PONV).(24 hours postoperatively)
研究者
Magdy Mohammed Mahdy Sayed
Principal Investigator
Assiut University