Efficacy of Intravenous Ibuprofen and Paracetamol on Postoperative Pain and Tramadol Consumption After Laparoscopic Cholecystectomy Surgery: A Prospective, Randomized, Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- •The primary objective of this study was to assess and compare the impact of iv ibuprofen and paracetamol on postoperative pain intensity through numeric rating scale .
研究概览
简要总结
Title
Efficacy of Intravenous Ibuprofen and Paracetamol on Postoperative Pain After Laparoscopic Cholecystectomy Surgery A Prospective Randomized Clinical Trial
Brief Summary
This prospective randomized clinical trial aims to compare the analgesic efficacy of intravenous IV ibuprofen and IV paracetamol in managing postoperative pain in patients undergoing laparoscopic cholecystectomy. A total of 80 adult patients aged 18 to 65 years with ASA physical status I to III will be randomly assigned to receive either IV ibuprofen 800 mg [10mg/kg body weight] or IV paracetamol 1 g [15mg/kg body weight] administered 30 minutes before the end of surgery. Pain intensity will be assessed using the Numeric Rating Scale NRS at 1st 6th 12th and 24 hours postoperatively. The primary objective is to compare postoperative pain scores between the two groups. Secondary outcomes include rescue tramadol requirements hemodynamic parameters and adverse drug effects. The study is being conducted at the Department of Anaesthesiology Institute of Medical Sciences Banaras Hindu University Varanasi.
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 85.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients Aged 18 To 85 Years.
- •Patients With American Society of Anesthesiologists (ASA) Physical Status Scores Ranging From 1 To
- •Patients Who Are Given Consent and Willing to Participate in This Study.
排除标准
- •Patients Classified as Having an ASA Score of IV Those Falling Outside the Specified Age Range.
- •Individuals With Peptic Ulcers, Severe Hepatic or Renal Failure, Significant Cardiovascular or Pulmonary Conditions.
- •A History of Drug Allergies (Specifically, Propofol, Fentanyl, Rocuronium, Paracetamol, Ibuprofen, And Tramadol).
- •As Well As Cases of Emergency Surgery.
- •Individuals Who Did Not Provide Informed Consent.
结局指标
主要结局
•The primary objective of this study was to assess and compare the impact of iv ibuprofen and paracetamol on postoperative pain intensity through numeric rating scale .
时间窗: Post operative 1st, 6th, 12th, and 24th hours
次要结局
- As secondary objectives, this study assesses tramadol consumption as rescue analgesic, analyzes intraoperative hemodynamic parameters, and the investigates any adverse effects related to study drugs in patients who underwent laparoscopic cholecystectomy surgery.(intraoperatively baseline , 5minutes ,10minutes ,30minutes ,60minutes ,90minutes ,120minutes)
研究者
Dr Lakshman P
Institute of Medical Sciences BHU