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临床试验/CTRI/2025/07/090170
CTRI/2025/07/090170尚未招募不适用

Effect of intravenous Dexamethasone on post operative analgesia following Ultrasound guided Transversus Abdominis Plane block in adult patient undergoing laparoscopic cholecystectomy under general anesthesia :Randomised placebo controlled study.

ABVIMS and Dr Ram Manohar Lohia Hospital1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2025年7月14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
108
试验地点
1
主要终点
Numeric Rating scoring(NRS)

研究概览

简要总结

This is a randomized placebo-controlled study investigating the effect of intravenous dexamethasone on postoperative analgesia in adult patients undergoing laparoscopic cholecystectomy under general anaesthesia. The study includes two groups (54 patients each), In Group A receives IV dexamethasone along with an ultrasound-guided Transversus Abdominis Plane block using 0.375% ropivacaine and in Group B receives normal saline instead of dexamethasone but the same ultrasound-guided Transversus Abdominis Plane block with 0.375% ropivacaine. The primary outcome is to assess the effect of dexamethasone on postoperative analgesia, measured using the Numerical Rating Scale (NRS) at specific time intervals.The secondary outcomes include evaluating the hemodynamic response and Postoperative Nausea and vomiting (PONV) scores at predetermined time points.

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 60.00 Year(s)(—)
性别
All

入选标准

  • ASA I and II , BMI Between 18-30kg/m2.

排除标准

  • 1.Pre-existing coagulation disorders 2.Local infection at the sites of injection.
  • 3.Any known drug allergies 4.History of diabetes.

结局指标

主要结局

Numeric Rating scoring(NRS)

时间窗: NRS scoring will be assessed - | 30 min after surgery. | 1 hour after surgery. | 2 hour after surgery. | 3 hour after surgery. | 6 hour after surgery. | 12 hour after surgery. | 24 hour after surgery.

次要结局

  • 1. Hemodynamic parameters (Pulse Rate, Systolic Blood Pressure ,Diastolic Blood Pressure and Mean Arterial Pressure)

研究者

发起方
ABVIMS and Dr Ram Manohar Lohia Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Ankita Shekhawat

ABVIMS and Dr Ram Manohar Lohia Hospital New Delhi

研究点 (1)

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