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临床试验/CTRI/2025/03/083310
CTRI/2025/03/083310尚未招募2/3 期

A comparative analysis of oral pregabalin versus placebo in managing postoperative pain, nausea and vomiting in patients undergoing laparoscopic cholecystectomy

ESI PGIMSR AND ESIC MEDICAL COLLEGE JOKA1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年4月4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
70
试验地点
1
主要终点
analyse the effect of oral pregabalin in managing postoperative pain using VAS(Visual Analog Scale). • To assess the incidence of post operative nausea, vomiting using four point ordinal score.

研究概览

简要总结

Laparoscopic cholecystectomy is one of the most common surgical procedures, however pain , nausea vomiting after this surgery is very frequent. Pain results to physiological and psychological response in patients which is detrimental to the postoperative outcome. Pathophysiology of pain have suggested that the central neural hyperexcitability that contributes to enhanced postoperative pain is preventable.  Different agents have been employed for preemptive analgesia such as nonsteroidal anti inflammatory drugs, NMDA antagonist and gamma amino butryic acid(GABA) analogues. Opioids are first alternative to treat moderate to severe pain but have adverse effects such as nausea , vomiting, respiratory depression and urinary retention. PONV is common in laparoscopic cholecystectomy. Nausea is a conscious recognition of subconscious excitation in an area of the medulla closely associated with or a part of vomiting centre, or it’s a sensation of discomfort in the upper abdomen and a sensation of unease with voluntary urge to vomit. Gabapentin has been used in managing postoperative pain and PONV. Compared to gabapentin, pregabalin pharmacokinetic is seen more favourable with better, faster, and more predictable absorption.

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 physical status 1 and 2 Patient posted for elective laparoscopic cholecystectomy.

排除标准

  • 1.Patient refusal to participate 2.Patient with ASA physical status 3 or more
  • History of drug or alcohol abuse 4.History of chronic pain 5.Patients with impaired kidney or liver function
  • History of allergy or contraindication to pregabalin or Gabapentin.
  • History of post operative nausea and vomiting in patients.

结局指标

主要结局

analyse the effect of oral pregabalin in managing postoperative pain using VAS(Visual Analog Scale). • To assess the incidence of post operative nausea, vomiting using four point ordinal score.

时间窗: I will assess the patient till 24 hour after giving Pregabalin tablet

次要结局

  • To assess the time of first rescue analgesic drug.(To assess the incidence of post operative nausea using four point ordinal score.)

研究者

发起方
ESI PGIMSR AND ESIC MEDICAL COLLEGE JOKA
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

KHUSHBOO KUMARI GUPTA

ESI PGIMSR ESIC Medical College and Hospital

研究点 (1)

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