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临床试验/CTRI/2024/04/064974
CTRI/2024/04/064974尚未招募4 期

Comparison of ultrasound-guided subcostal transversus abdominis plane block and quadratus lumborum block in laparoscopic cholecystectomy: A prospective, randomized, comparative study

Dr Navjeet Singh1 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2024年4月10日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
98
试验地点
1
主要终点
Pain score based on visual analogue scale

研究概览

简要总结

The recent concept of "multimodal analgesia" is a better approach that utilizes several agents with varying modes of action on pain control pathways to reduce postoperative pain.

Regional analgesia techniques like Transverse Abdominis Plane (TAP) Block &Quadratus Lumborum (QL)Block are more popular as they are pharmacologically safe and effective.

Opioid sparing anaesthesia using blocks with a propensity to provide better post operative analgesia than opioid based anaesthesia which has shown to have poor patient recovery due to opioid causing side effects.

•        Very few studies has been done comparing TAP and QL block, worldwide especially in India, we aim to compare the effectiveness of these blocks.

The minimum sample size required for our current study is 98 patients.

Randomization of the sample will be done by the computer-generated block using random number generator to create list of random numbers.

  1. GROUP A to get TAP block using 20 mL of bupivacaine hydrochloride 0.25% (group A, n=49)

2.  GROUP B to get QL block using 20 mL of bupivacaine hydrochloride 0.25% (group B, n=49)

After skin closure, under all aseptic and antiseptic precautions, USG guided TAP and QL Blocks will be administered using (20ml of 0.25% Bupivacaine) following double blind technique

•        The patient will be monitored for postoperative pain by VAS Scoring at 1 hr,2hr ,4hr, 8hr, 12hr and 24 hours post operatively.

•        Patients will also be observed for any rescue analgesia required and any side effects.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • ASA I & II
  • Patient posted for elective laparoscopic Cholecystectomy
  • Patient willing to give written informed consent to be a part of the study.

排除标准

  • Patient refusal to provide consent
  • Morbid obesity
  • Local infection at site of block
  • ASA grade>2
  • History of any psychiatric illness/substance abuse/medical therapies resulting in tolerance to opioids.

结局指标

主要结局

Pain score based on visual analogue scale

时间窗: post operatively after 1 hour,2 hours, 4 hours, 8 hours, 12 hours,24 hours

次要结局

  • 1. need for rescue analgesia(2. side effects of the procedure)

研究者

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

Dr. Navjeet Singh

Bokaro General Hospital

研究点 (1)

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