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临床试验/CTRI/2024/07/070462
CTRI/2024/07/070462招募中3 期

Postoperative pain relief with intraperitoneal bupivacaine after laparoscopic cholecystectomy

Dr Satya1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年8月1日最近更新:

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
Postoperative pain score by visual analogue pain scale

研究概览

简要总结

A randomized control trial with a sample size of 30 in each group. After getting the approval from the institution ethics committee, patients who satisfy the inclusion criteria and exclusion criteria will be included in the study. All patients will be admitted and a detailed history, relevant clinical examination and relevant investigations will be done. After establishing the diagnosis, the patients will be subjected to Laparoscopic cholecystectomy. After obtaining consent, Patients will be randomly allotted into blocks and separated into control group  and test group. Patients in test group will receive  20 ml of 0.25% BUPIVACAINE administered via cannula into the region of gallbladder bed after the gallbladder is dissected. The patients in control group will not receive any medications intraoperatively. Both the groups will be assessed with visual analogue pain scale with a score of 0-10 at 0 hr, 2 hr, 4 hr, 6 hr and at 12 hours post surgery. Patients will be prescribed INJ. TRAMADOL 50mg intravenous sos. Drug utilization will be reviewed at 24 hours. Time taken to start mobilizing and duration of stay are noted. Pain score, analgesic usage, postoperative nausea, time to mobilize and duration of stay are compared between the two groups and analyzed.

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 80.00 Year(s)(—)
性别
All

入选标准

  • Patients undergoing laparoscopic cholecystectomy.

排除标准

  • Known allergy to local anaesthetics.
  • Known cardiac issues.
  • Procedures converted to open cholecystectomy.
  • Patients who do not consent.
  • Patients with acute cholecystitis.

结局指标

主要结局

Postoperative pain score by visual analogue pain scale

时间窗: 0,2,4,6 hours postoperatively

次要结局

  • Analgesic usage(Time taken to start mobilizing)

研究者

发起方
Dr Satya
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Satya

SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH

研究点 (1)

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