To Compare Postoperative Analgesic Effect of Oral Pregabalin versus Oral Clonidine in Lower Limb Surgeries Under Spinal Anaesthesia
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Effectiveness of oral pregabalin, oral clonidine and placebo
研究概览
简要总结
Background: Effective postoperative pain management is crucial for optimal recovery in lower limb surgeries performed under spinal anesthesia. Pregabalin and clonidine are both known for their analgesic properties, but their comparative effectiveness in this specific context remains to be rigorously evaluated.
Objective: This study aims to compare the postoperative analgesic effects of oral pregabalin versus oral clonidine in patients undergoing lower limb surgeries under spinal anesthesia.
Methods: A randomized controlled trial will be conducted with patients scheduled for elective lower limb surgeries under spinal anesthesia allocated to receive either oral pregabalin or oral clonidine preoperatively. Postoperative pain will be assessed at regular intervals, supplemented by evaluation of additional analgesic requirements and monitoring of adverse effects associated with each treatment. Outcome: Findings from this study will provide valuable insights into the relative efficacy and safety profiles of oral pregabalin and oral clonidine for postoperative pain management in lower limb surgeries under spinal anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •American society of anesthesiologist class I, class II patients aged 18-65 years of either sex.
- •Patients posted for lower limb surgeries under spinal anesthesia.
排除标准
- •Patients with hypersensitivity to study drugs
- •Patients suffering from central nervous system disorder and coagulation disorders
- •Contraindications to regional anesthesia such as anatomic disorders of spine, shock, local site infections, peripheral neuropathy
- •Opioid dependents
- •Patient suffering from chronic pain conditions.
结局指标
主要结局
Effectiveness of oral pregabalin, oral clonidine and placebo
时间窗: from the end of surgery till 24 hours
on postoperative analgesia in lower limb surgeries under spinal anesthesia.
时间窗: from the end of surgery till 24 hours
次要结局
- Requirement of rescue analgesics in 24hrs post operatively(among all the three groups and Hemodynamic changes.)
研究者
Dr Anita Kumari
Sri Guru Ram Das Institute of Medical Sciences and Research