Comparative Efficacy of Gabapentin and Diclofenac Sodium for Post-Operative Pain Relief in Patients Undergoing Major Abdominal Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Pain reduction
研究概览
简要总结
Little is known about comparative efficacy of gabapentin and diclofenac sodium in managing post-operative pain. Therefore, this study was planned to compare the efficacy of gabapentin, and diclofenac sodium for post-operative pain relief in patients undergoing major abdominal surgeries.
详细描述
Non-steroidal anti-inflammatory drugs, opioid analgesics, and local and regional anesthesia have been used as preventive interventions, but their role in postoperative pain management remains inconclusive. Gabapentin is a relatively new drug for postoperative pain management whose side effects are well tolerated. If the findings of this study produce similar observations, it would add to the already scarce data and help patients undergoing major abdominal surgeries in the local settings in relieving postoperative pain effectively.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any gender
- •Aged 18-60 years
- •Undergoing elective major abdominal surgery under general anesthesia
- •With physical status I or II
- •Who were able to comprehend and use the Visual Analogue Scale (VAS) for pain assessment
排除标准
- •With a known allergy or contraindication to gabapentin, or diclofenac sodium
- •A history of peptic ulcer disease
- •A history of gastrointestinal bleeding
- •Hepatic or renal dysfunction
- •Pregnancy or lactation
- •With neurological or psychiatric disorders affecting pain perception
- •Received opioids, anticonvulsants, antidepressants, or nonsteroidal anti-inflammatory drugs (NSAIDs) within 24 hours before surgery
- •With uncontrolled hypertension, ischemic heart disease, or diabetes mellitus
- •Those who experienced intraoperative complications necessitating a change in anesthetic plan or postoperative mechanical ventilation
研究组 & 干预措施
Gabapentin group
Patients received a single oral dose of gabapentin 600 mg one hour before surgery.
干预措施: Gabapentin 600mg (Drug)
Diclofenac group
Patients were given a single oral dose of diclofenac sodium 100 mg one hour before surgery.
干预措施: Diclofenac Sodium 100 MG (Drug)
结局指标
主要结局
Pain reduction
时间窗: 12 hours
Patients were considered to have effective pain relief ("Yes") if their VAS score remained ≤3 throughout the monitoring period without requiring rescue analgesia.
次要结局
未报告次要终点
研究者
Muhammad Aamir Latif
Research Consultant
RESnTEC, Institute of Research