A comparative study of Epidural Nalbuphine vs Tramadol as an adjuvant to 0.2% Ropivaciane for post operative pain relief in unilateral total knee replacement surgeries.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Post operative pain assessment
研究概览
简要总结
This study is a randomized control double blind study , single centre trial comparing the efficacy of Nalbuphine 0.2mg/ml and Tramadol 2mg/ml as an adjuvant to 0.2% Ropivacaine epidurally for post-op analgesia in unilateral total knee replacement surgery. Total sample size is 50 patients divided in two equal groups. The primary outcome measures will be difference in VAS score between groups at 30 minutes, 60 minutes, 2 hours, 4 hours, 6 hours, 12 hours and 24 hours. The secondary outcomes will be patient satisfaction, post-op nausea and vomiting and requirement of breakthrough analgesia.
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
- 45.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •Giving the consent ASA grade 1 and 2 Age groups 45-70 years.
排除标准
- •ASA 3/4 Refusal of consent Bleeding diathesis Contraindication to epidural anaesthesia Pregnancy and lactating mother.
结局指标
主要结局
Post operative pain assessment
时间窗: 30 mins 1 hr 2 hr 4 hr 6 hr 12 hr 24 hr
次要结局
- PONV , patient satisfaction(30 mins 1 hr 2 hr 4 hr 6 hr 12 hr 24 hr)
研究者
Dr Harshita jain
Rukmani Birla hospital
