Efficacy of ultrasound guided bilateral erector spinae plane block for postoperative analgesia in patients undergoing laparoscopic cholecystectomy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Postoperative pain using a visual analog scale (VAS) in both groups at rest and dynamic pain on coughing.
研究概览
简要总结
Pain is the dominating complaint and the primary reason for prolonged convalescence after laparoscopic cholecystectomy1. It has been hypothesized that intense acute pain after laparoscopic cholecystectomy may predict development of chronic pain (e.g. Post laparoscopic cholecystectomy syndrome)2. Erector spinae plane block is a novel thoracic myofascial plane block that was reported first in 2016.3 It is a simpler and safer alternative to thoracic paravertebral and epidural blockade because the sonographic target is easily visualized and the site of injection is distant to the neuraxis and any major vascular structures and provides more extensive cranio-caudal spread with a single injection without major complications4
Objective : To study and compare the analgesic efficacy of single shot bilateral erector spinae plane block in patients undergoing laparoscopic cholecystectomy.
DESIGN : Double blind , prospective, randomized controlled study
Methodology : A blinded anaesthetist 1 will explain about ESP block to patient and takes I/W consent in preoperative period and he will also collect the data later on.
On day of surgery anaesthetist 2 will prepare 2 syringes of 20ml 0.375% ropivacaine or normal saline as per computer generated random table and assign a number and accordingly group (1/2) to the patient.
A blinded anaesthetist 3 will give bilateral ESP block with 20 ml of drug each side under USG guidance after induction of anaesthesia.
Anaesthetist 1 will manage case as per protocol with 2mcg/kg fentanyl at induction, 1mcg/kg at port insertion.
Inj. Paracetamol 1gm iv pre-emptively
Fentanyl repeated after 1 hour henceforth 1mcg/kg if needed
Inj. Paracetamol 1 gm iv will be continued 8th hourly.
Rescue analgesic in postoperative period (when the VAS > 4) : Inj. Diclofenac 75mg iv
References :
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Bisgaard T, Klarskov B, Rosenberg J, Kehlet H: Factors determining convalescence after uncomplicated laparoscopic cholecystectomy. Arch Surg 2001; 136:917–21
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Bisgaard T, Rosenberg J, Kehlet H: From acute to chronic pain after laparoscopic cholecystectomy: A prospective follow-up analysis. Scand J Gastroenterol 2005; 40:1358–64
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Forero M, Adhikary SD, Lopez H, et al. The erector spinae plane block: A novel analgesic technique in thoracic neuropathic pain. Reg Anesth Pain Med 2016;41:621–7
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Forero M, Rajarathinam M, Adhikary S, et al. Continuous erector spinae plane block for rescue analgesia in thoracotomy after epidural failure: A case report. A A Case Rep 2017;8:254–6
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA I and II patients, Undergoing elective laparoscopic cholecystectomy under general anaesthesia.
排除标准
- •Patients with contraindications for regional anesthesia, known allergy to local anesthetics, bleeding diathesis, use of anticoagulants or corticosteroids, psychiatric disorders.
结局指标
主要结局
Postoperative pain using a visual analog scale (VAS) in both groups at rest and dynamic pain on coughing.
时间窗: 0 (at arrival in postoperative ICU), 1, 6, 12, 24 hours
次要结局
- Total need for rescue analgesic in postoperative period(24 hrs postoperatively)
- Intraoperative total fentanyl consumption(At the end of surgery)
- Time to ambulation of patient(At 6hrs, 12hrs, 18hrs or 24 hours.)