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临床试验/CTRI/2025/07/090553
CTRI/2025/07/090553尚未招募2/3 期

Evaluation of fentanyl vs dexmedetomidine as adjuvant with ropivacaine in USG guided transversus abdominis plane block for laparoscopic cholecystectomy on post operative analgesia a comparative study

SGRD1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2025年8月1日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
108
试验地点
1
主要终点
Duration of analgesia by both the drugs when used as adjuvants to

研究概览

简要总结

Introduction:Postoperative pain management is crucial for enhancing patient recovery and reducing hospital stays. The Transversus Abdominis Plane (TAP) block, guided by ultrasound, is a popular regional anesthesia technique for abdominal surgeries. Ropivacaine, a long-acting local anesthetic, is commonly used in TAP blocks. However, the addition of adjuvant analgesics such as Fentanyl and Dexmedetomidine may further enhance pain relief. Aims and Objectives: This study aims to compare the analgesic efficacy of Fentanyl and Dexmedetomidine as adjuvants to Ropivacaine in patients undergoing abdominal surgery with an ultrasound-guided TAP block. Methodology:A randomized, double-blind, controlled trial will be conducted with patients scheduled for elective abdominal surgery. Participants will be randomly assigned to three groups: Group R (Ropivacaine alone), Group RF (Ropivacaine with Fentanyl), and Group RD (Ropivacaine with Dexmedetomidine). All patients will receive an ultrasound-guided TAP block. Primary outcomes will include pain scores at rest and during movement, assessed at 1, 4, 8, 12, and 24 hours postoperatively using a Visual Analog Scale (VAS). Secondary outcomes will include total opioid consumption in the first 24 hours postoperatively, incidence of side effects, and patient satisfaction scores. Outcome/Significance:This study will provide valuable insights into optimizing postoperative pain management protocols for abdominal surgery. If successful, the findings could support the use of Dexmedetomidine as a preferred adjuvant to Ropivacaine in TAP blocks, improving patient outcomes and enhancing recovery.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant 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 physical status I and II.

排除标准

  • Acute cholecystitis.
  • Carcinoma Gall bladder
  • Hypersensitivity to study drugs
  • Pregnant females
  • Bleeding disorders
  • Opioid addicts.

结局指标

主要结局

Duration of analgesia by both the drugs when used as adjuvants to

时间窗: at | 0, 2, 4, 6, 12, and 24hrs after surgery.

Ropivacaine given through sub coastal TAP block using VAS.

时间窗: at | 0, 2, 4, 6, 12, and 24hrs after surgery.

次要结局

  • Side effects like hypotension, bradycardia, postoperative nausea(vomiting, respiratory depression or any other complication arising during the study will)

研究者

发起方
SGRD
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Lakshmi Mahajan

Sri Gur Ram Das Institute of Medical Sciences and Research, Mehta Road, Vallah, Amritsar

研究点 (1)

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