Comparative Study Of Epidural Nefopam And Tramadol For Post-operative Pain Management In Lower Abdominal Surgeries: A Randomised Comparative Clinical Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To assess and compare the analgesic efficacy of epidural nefopam versus tramadol in patients undergoing lower abdominal surgeries using Visual Analog Scale (VAS) pain score.
研究概览
简要总结
Summary This prospective, randomized comparative clinical trial investigates the effectiveness and safety of epidural nefopam versus epidural tramadol for postoperative pain management in adult patients undergoing lower abdominal surgeries. One hundred eligible patients will be randomized into two groups:
- Group N (Nefopam): 8 ml of 0.125% bupivacaine with 5 mg nefopam epidurally
- Group T (Tramadol): 8 ml of 0.125% bupivacaine with 20 mg tramadol epidurally
The primary outcome is postoperative pain intensity measured by Visual Analog Scale (VAS) at rest and during movement over 24 hours. Secondary outcomes include onset and duration of analgesia, need for rescue analgesics, and incidence of adverse effects such as nausea, vomiting, sedation, hypotension, urinary retention, and respiratory depression.
The study aims to determine whether epidural nefopam can provide pain relief comparable to tramadol while reducing opioid-related side effects. Findings are expected to guide clinicians in selecting optimal epidural analgesics for enhanced recovery, improved patient satisfaction, and reduced opioid use in lower abdominal surgery patients.
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 I and II 2) Patients scheduled for lower abdominal surgeries 3) Patients capable of providing informed written consent and understanding pain assessment instruction 4) Body Mass Index less than 35 kg per metre square.
排除标准
- •Patient refusal 2) Contraindication to neuraxial anaesthesia 3) History of significant cardiovascular, respiratory, hepatic or renal dysfunction 4) Known hypersensitivity to study medications 5) History of chronic pain or regular analgesic medication use 6) Psychiatric disorders or inability to comprehend pain assessment tools 7) Pregnancy or Lactation 8) Body Mass index more than 35 kg per metre square.
结局指标
主要结局
To assess and compare the analgesic efficacy of epidural nefopam versus tramadol in patients undergoing lower abdominal surgeries using Visual Analog Scale (VAS) pain score.
时间窗: 1st, 2nd, 4th, 6th, 12th ,24th hour
次要结局
- To compare the incidence and severity of adverse effects associated with epidural nefopam and tramadol(upto first 24 hours postoperatively)
研究者
Dr Prasanna Vadhanan
Vinayaka Missions Medical College and Hospital