Efficacy of Nalbuphine versus Fentanyl as Epidural Adjuvants to Bupivacaine for Postoperative Analgesia in Infraumbilical Surgeries: A Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Duration of postoperative analgesia, defined as the time from epidural drug
研究概览
简要总结
This study aims to compare the efficacy and safety of nalbuphine and fentanyl as epidural adjuvants to 0.125 percent bupivacaine for postoperative analgesia in patients undergoing infraumbilical surgeries. Inadequate pain control after surgery can delay recovery and increase complications therefore optimizing epidural analgesia is crucial. Fentanyl a commonly used opioid offers effective pain relief but may cause side effects such as respiratory depression and nausea. Nalbuphine a kappa agonist and partial mu antagonist provides comparable analgesia with fewer side effects. Sixty adult patients ASA I and II scheduled for elective infraumbilical surgeries under combined spinal epidural anaesthesia will be randomly assigned to receive either nalbuphine 10 mg or fentanyl 100 mcg with 0.125 percent bupivacaine via the epidural route. Postoperative parameters including duration of analgesia pain scores using the Visual Analog Scale haemodynamic stability and side effects will be monitored. The expected outcome is that nalbuphine will produce longer lasting analgesia lower pain scores and fewer opioid related adverse effects compared to fentanyl.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Double
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 1 and 2
- •Patients undergoing elective infraumbilical surgeries under combined spinal-epidural anaesthesia
- •Patients willing to provide informed consent.
排除标准
- •Patients on opioids, tricyclic antidepressants, or alpha-2 agonists
- •Patients with neuromuscular disorders
- •Patients with disease and deformities of spinal cord
- •Patients allergic to local anaesthetic drugs.
结局指标
主要结局
Duration of postoperative analgesia, defined as the time from epidural drug
时间窗: 0 min, 5 min, 10 min, 15 min, 20 min, 25 min, 30 min, 1 hr, 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 4.5 hr, 5 hr, 5.5 hr, 6 hr, 7 hr, 8 hr, 10 hr, 12 hr after administering drug
administration to the first request for rescue analgesia
时间窗: 0 min, 5 min, 10 min, 15 min, 20 min, 25 min, 30 min, 1 hr, 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 4.5 hr, 5 hr, 5.5 hr, 6 hr, 7 hr, 8 hr, 10 hr, 12 hr after administering drug
次要结局
- Pain scores at rest & movement using the Visual Analog Scale (VAS) at predefined(time intervals)
- Incidence of side effects & derangement in haemodynamic parameters(From 0 min of administering drug & 5 min, 10 min, 15 min, 20 min, 25 min, 30 min, 1 hr, 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 4.5 hr, 5 hr, 5.5 hr, 6 hr, 7 hr, 8 hr, 10 hr, 12 hr after administering drug)
研究者
Dr. R. Brindha
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals