A prospective double blinded control study comparing the efficacy of Pregabalin and Gabapentin as a premedication in influencing postoperative analgesia for lower abdominal surgeries performed under subarachnoid block
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- To compare the intensity of postoperative pain in 3 groups by numeric pain intensity scale (NPIS) for 24 hours.
研究概览
简要总结
A randomised double blinded control study comparing the efficacy of oral pregabalin and gabapentin as a premedication in influencing postoperative analgesia****for 72 patients posted for lower abdominal surgeries performed under subarachnoid block. The primary objective would be to compare the intensity of postoperative pain in 3 groups by numeric pain intensity scale (NPIS) for 24 hours.The secondary objectives are to compare the time interval between subarachnoid block and first rescue analgesics,To evaluate total dosage of rescue analgesics given in first 24 hours,To assess the sedation score of the drug and To evaluate the presence of any adverse effects of drug (diplopia, nausea, vomiting, diarrhoea, confusion, respiratory depression).
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator 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
- •Patients of both sexes consenting for lower abdominal surgeries under subarachnoid block BMI between18-25 kg/m2.
排除标准
- •ASA III and above physical status Pregnancy and Lactating mother Known psychiatric disorder Patients with cardiac disease or chronic kidney disease All neuropathies coagulopathies patient refusal for spinal anaesthesia Failed spinal inadequate level of block high spinal prolonged surgery Patient with allergic to the drug Patient who are already on Pregabalin or Gabapentin.
结局指标
主要结局
To compare the intensity of postoperative pain in 3 groups by numeric pain intensity scale (NPIS) for 24 hours.
时间窗: postoperative period
次要结局
- To evaluate the presence of any adverse effects of drug (diplopia, nausea, vomiting, diarrhoea, confusion, respiratory depression).(intraoperative and postoperative peroid)
- To evaluate total dosage of rescue analgesics given in first 24 hours.(postoperative period)
- To compare the time interval between subarachnoid block and first rescue analgesic(from intraoperative peroid till postoperative peroid)
- To assess the sedation score of the drug(intraoperative and postoperative peroid)