Dose Esmolol Infusion Have an Adjuvant Effect to Transversus Abdominis Plane Block for Pain Control in Laparoscopic Cholecystectomy: A Randomized Controlled Double-blind Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- pain rescue-analgesia consumption
研究概览
简要总结
Pain after laparoscopy differs considerably from that seen after laparotomy. Laparotomy results mainly in parietal pain (abdominal wall), where as Pain in laparoscopy results from stretching of the intra-abdominal cavity, peritoneal inflammation, and diaphragmatic irritation caused by residual carbon-dioxide in the peritoneal cavity. The transverse abdominis plane (TAP) block is a peripheral nerve block designed to anesthetize the nerves supplying the anterior abdominal wall (T6 to L1). While esmolol is an ultra-short acting intravenous β-blocker having a rapid onset and offset effect. It provides an unprecedented level of tolerability and safety in the perioperative setting. When used as an adjunct, it has been shown to improve the postoperative recovery by reducing postoperative pain intensity and intraoperative anesthetic and opioid requirements and preventing opioid-induced hyperalgesia . The mechanism of this synergistic effect is uncertain, but both pharmacokinetic and pharmacodynamics interactions with anesthetic drugs have been proposed.
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, Investigator)
盲法说明
double blinded
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
- •ASA grade I/II patients undergoing laparoscopic cholecystectomy .
- •Age group of 18 -60 years.
- •Patients giving valid informed consent.
排除标准
- •Patient refusal
- •Patients belonging to ASA grade III and grade IV .
- •Coagulation disorders.
- •Patients with known allergy to one of the used drugs.
- •Extreme obesity (BMI >35)
- •Patients with cardiac, pulmonary, hepatic or renal disorders
- •Drug abusers
研究组 & 干预措施
Group E (esmolol infusion)
10 minutes before induction of anesthesia the patients will receive a loading dose of injection esmolol 0.5 mg/kg in 30 ml isotonic saline in the IV line, followed by an IV infusion of esmolol 0.05 mg/kg/min till the completion of surgery After induction of anesthesia and before starting the surgery, patients will receive bilateral in-plane ultrasound guided transversus abdominis plane block with 40 ml of bupivacaine 0. 25% after induction of anesthesia 20 ml in each side .
干预措施: Esmolol (Drug)
Group T (TAP block)
10 minutes before induction of anesthesia the patients will receive a loading dose of injection 30 ml isotonic saline in the iv line, followed by an IV infusion of saline at a rate of 0.05 mg/kg/min till the completion of surgery After induction of anesthesia and before starting the surgery, patients will receive bilateral in-plane ultrasound guided transversus abdominis plane block with 40 ml of bupivacaine 0. 25% after induction of anesthesia 20 ml in each side.
干预措施: Esmolol (Drug)
结局指标
主要结局
pain rescue-analgesia consumption
时间窗: 24 hours postoperative
. If pain score exceed 3, rescue analgesia 5 mg bolus of morphine will be administered intravenous to achieve satisfactory pain control that can be repeated every 4-6 hours.
次要结局
- Intraoperative hemodynamic data(30 minutes after induction of anesthesia)
- Visual analogue pain score(every 0,2,4,6,12, up to 24 hours postoperative)
- Postoperative nausea and vomiting(24 hours postoperative)
- Patient satisfaction(24 hours postoperative)
研究者
Samar Rafik Mohamed Amin
lecturer of anesthesia and surgical ICU
Benha University