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临床试验/CTRI/2026/01/100403
CTRI/2026/01/100403尚未招募不适用

USG guided subcostal TAP block with dexamethasone versus magnesium sulfate as adjuvants with ropivacaine 0.2% A prospective randomised controlled study in patients undergoing laparoscopic cholecystectomy

Reshma B M1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年1月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
50
试验地点
1

研究概览

简要总结

Laparoscopic cholecystectomy is one of the most commonly performed surgery. Subcostal TAP block is one of the effective methods of providing analgesia. In our study we compare the effect of two different adjuvants with 0.2% Ropivacaine in prolonging the duration of analgesia.

After obtaining institutional ethical clearance and clinical trial registration, patients will be enrolled in the study. A thorough preanaesthetic evaluation will be done, based on inclusion and exclusion criteria patients will be selected and recruited after obtaining a written informed consent. Patients are grouped into 2 - Group A will receive 0.2% ropivacaine 18 ml with 8mg dexamethasone and Group B will receive 18ml 0.2% ropivacaine with 200mg magnesium sulfate on each side. Patient will be informed about the study protocol. Based on computer generated random numbers they are put into 2 group with allocation concealment via sealed envelopes that will be opened just before performing the block.  Standard preanaesthesia protocol regarding nil per oral status and premedication will be followed. Induction and maintenance is based on standard anaesthesia practise of our hospital. After the completion of surgery patients are given USG guided subcostal TAP block based on the groups alloted. Patients are extubated and postoperatively followed up at 2, 4, 8, 12, 18 and 24 hours. Hemodynamic parameters, VAS scores, need for analgesia , side effects , PSS are noted.

研究设计

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

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients belonging to ASA PS 1 and
  • Patients undergoing elective laproscopic cholecystectomy under general anaesthesia.

排除标准

  • BMI more than 35kg/m2 and less than 18kg/m
  • Pregnancy and lactation.
  • Allergy to local anaesthetics and/or adjuvants.
  • Patients with severe cardiac disorders.
  • Patients refusal to participate in the study.

研究者

发起方
Reshma B M
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Reshma B M

Dr B R Ambedkar medical college and hospital

研究点 (1)

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