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临床试验/NCT05264805
NCT05264805Unknown3 期

A Randomized Controlled Trial of Port Site Subcutaneous Injection of Bupivacaine to Determine the Effectiveness of Postoperative Pain Relief After Laparoscopic Cholecystectomy

Hamdard University0 个研究点目标入组 166 人开始时间: 2022年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
入组人数
166
主要终点
Post laparoscopic port site pain assessment

研究概览

简要总结

To determine the effectiveness of port site bupivacaine infiltration in postoperative pain reduction after laparoscopic cholecystectomy.

详细描述

The study is being done to determine the effectiveness of port site bupivacaine infiltration in postoperative pain reduction after laparoscopic cholecystectomy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients of both the gender of age >18 years and <45years
  • Patients undergoing elective laparoscopic cholecystectomy under general anesthesia.
  • Patients with A.S.A grade I and II.

排除标准

  • Patients with known allergic reactions to local anesthetics.
  • Patients converted to open procedure.
  • Patients developing intra-operative complications.
  • Patients undergoing for laparoscopic cholecystectomy for acute cholecystitis.
  • Patients with obesity and chronic illness.
  • Patients with history of opioids, steroids, NSAIDs and alcohol use.

研究组 & 干预措施

Bupivacaine group

Experimental

Patient receiving 20ml of inj. 0.25% Bupivacaine at laparoscopic port site

干预措施: 0.25% Bupivacaine (Drug)

结局指标

主要结局

Post laparoscopic port site pain assessment

时间窗: Pain assessment from 0hour (patient received in recovery room) till 12hours postoperatively at interval of 3hours i.e. 0,3,6,9,12 hour

Pain assessment by "Visual Analog Scoring system" scoring from 0 to 10, where 0 means no pain and 10 means worst possible, unbearable excruciating pain.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Nida Shahid

Assistant Professor

Hamdard University

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