A Prospective Randomised Double Blinded Study to compare the efficacy and outcome of intraoperative periarticular cocktail infiltration with Clonidine Vs Magnesium Sulphate and Sodium Bicarbonate in patients undergoing total knee arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- To compare the post operative functional outcome in terms of pain relief and early mobilization of Clonidine as an adjuvant versus MgSO4 & NaHCO3 as an adjuvant in periarticular cocktail infiltration.
研究概览
简要总结
This study is a randomised ,double blinded, parallel group, single centre study. The estimated sample size for this study is 66. The patients will be divided into 2 groups containing 33 people in each group. Group 1 will be receiving Clonidine as an adjuvant with the periarticular cocktail whereas Group 2 will be receiving Magnesium Sulphate and Sodium Bicarbonate as an adjuvant. The primary objective is to compare the post operative functional outcome in terms of pain relief and early mobilisation (within 48hrs post-operatively) of Clonidine as an adjuvant versus MgSO4 & NaHCO3 as an adjuvant in periarticular cocktail infiltration. Secondary objective is use of rescue analgesia in the form of Injection Tramadol (50 mg), intravenous and also the frequency of the requirement of rescue analgesia during the early post operative period(i.e. within POD 5), and to assess ROM post operatively till the day of discharge(POD-5) .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Unilateral Total Knee Replacement.
排除标准
- •History of allergy to the medications used in the study,Patients undergoing extensive soft tissue release, Severe varus knees (HKA greater than 10), Inflammatory arthritis, Painful Hip pathology, Patients with intra-operative fractures, Previous history of steroid injection into the knee joint ,Patients undergoing revision surgery or any history of prior operation around the knee.
结局指标
主要结局
To compare the post operative functional outcome in terms of pain relief and early mobilization of Clonidine as an adjuvant versus MgSO4 & NaHCO3 as an adjuvant in periarticular cocktail infiltration.
时间窗: VAS score at 2hours, 4 hours,6hours, 8 hours, 10hours, 12 hours,24 hours, 48 hours
次要结局
- Use of rescue analgesia in the form of Injection Tramadol (50 mg), intravenous and also the frequency of the requirement of rescue analgesia during the early post operative period(i.e. within POD 5), To assess ROM post operatively till the day of discharge(POD-5)(ROM at POD-0,1,2,3,4,5)
研究者
Dr Anurag Das
All India Institute of Medical Sciences, Patna