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临床试验/CTRI/2024/08/072020
CTRI/2024/08/072020尚未招募3 期

Comparison of postoperative analgesia and opioid consumption in ultrasound guided bilateral intertransverse process block versus bilateral erector spinae plane block in patients undergoing laparoscopic cholecystectomy

Dr Nikitha A1 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2024年8月20日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
94
试验地点
1
主要终点
1)Compare the postoperative visual analogue scale in laparoscopic cholecystectomy in patients receiving intertransverse process plane block and erector spinae plane block using 0.125% bupivacaine

研究概览

简要总结

Erector spinae plane block and intertransverse process block are regional analgesic techniques that are the latest developments in postoperative pain therapy. Both techniques are used for pain relief  after mastectomy, thoracic ,abdominal and spinal surgery and are found effective due to their simplicity and lower risks compared to epidural analgesia1. The aim of the study is to compare the effect of ultrasound guided bilateral intertransverse process block versus bilateral ultrasound guided erector spinae plane block on postoperative analgesia and the opioid consumption in terms of morphine equivalence in patients undergoing laparoscopic cholecystectomy under general anesthesia by a prospective randomized double blind trial.

In this study, patients undergoing laparoscopic cholecystectomy will be divided into two equal groups, one group receiving ultrasound guided intertransverse process block using 0.125% bupivacaine and the other group receiving ultrasound guided erector spinae block using 0.125% bupivacaine. Intraoperatively the two groups will receive fentanyl 2mcg/cc, loading dose of  dexmedetomidine 0.5 mcg/kg in 10 minutes and maintenance dose of 0.2-0.3mcg/kg/hr. till the end of surgery, paracetamol 1 Gram and inj diclofenac 75 milligrams. Their requirement of rescue analgesics , postoperative analgesics and opioid consumption in terms of morphine equivalence will be recorded over 36 hrs. Thus analgesic efficacy of both blocks can be assessed and thus will help in effective postoperative pain management in patients undergoing laparoscopic cholecystectomy.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Patients undergoing laparoscopic cholecystectomy above 18 years belonging to ASA1,ASA2 and ASA 3 Category.

排除标准

  • ASA IV patients 2)Coagulopathy 3)Patient refusal 4)History of allergy to LA 5)Contraindication to any analgesics 6)Chronic pain disorders 7)Infection at the injection site 8)Pregnancy 9)Neurological cognitive disorder 10)Patients on anticoagulants 11)Acute abdomen 12)Coincidental surgeries 13)Patients with surgical drain 14)Gall bladder adhesions.

结局指标

主要结局

1)Compare the postoperative visual analogue scale in laparoscopic cholecystectomy in patients receiving intertransverse process plane block and erector spinae plane block using 0.125% bupivacaine

时间窗: 2 years

次要结局

  • 1)To measure and compare the consumption of opioid rescue analgesic and postoperative analgesics in terms of morphine equivalence over 36 hr postoperative period or till discharge whichever is earlier between two groups.(2 years)

研究者

发起方
Dr Nikitha A
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Nikitha A

ASTER CMI HOSPITAL,HEBBAL

研究点 (1)

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