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临床试验/CTRI/2021/11/038194
CTRI/2021/11/038194已完成不适用

Femoral Triangle vs Adductor canal vs Dual Sub-Sartorial Block - Choosing the Best Motor Sparing Block for Knee Arthroplasty in 2021 (FAD21): prospective double blinded randomised controlled trial

Ganga Medical Centre and Hospitals Pvt Ltd1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2021年11月25日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
1
主要终点
To measure post block quadriceps strength

研究概览

简要总结

Post-operative pain associated with Total knee arthroplasty has challenged the regional anaesthetists to find better alterative to opioids to improve the patient experience by minimizing the ill-effects of opioids. With the recent introduction of ERAs, the limitations of muscle weakness associated with conventional nerve blocks for TKR was faced with criticism. The description of motor sparing blocks led to the introduction of multiple blocks. However, no one block has yet been described which has been able to provide the comfort associated with the conventional techniques. Adductor canal block(ACB) and Femoral triangle(FT) blocks are the widely practised motor sparing blocks as part of ERAs protocol. Dual sub sartorial block(DSB) is a recently described block which has been found to be a promising procedure specific block.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Scheduled for elective knee arthroplasty Accepted mental state of the patient ASA 1 and 2 patients Unilateral TKR.

排除标准

  • Patient Refusal Patients with polytrauma Infection at the injection site of block Known allergy to local anaesthetics Advanced hepatic & renal failure Chronic opioid consumption Coagulopathy Severe valgus deformity Lateral approach for TKR Augmented TKR Revision TKR.

结局指标

主要结局

To measure post block quadriceps strength

时间窗: 6 hr, 12 hr, 18 hr, 24 hr, 36 hr, 48 hr, 72 hr and at discharge

次要结局

  • To observe analgesic efficacy of each block(Post Block VAS score (0-10) at 30min, 60min, 90min,120 min, 4 hr, 6 hr, 8 hr, 10 hr,12 hr, 18 hr, 24 hr, 36 hr, 48 hr, 72 hr and at Discharge)
  • Post Block Opioid (morphine equivalents) Consumption(post block Opioid (Morphine equivalents) consumption till discharge)
  • Patient Satisfaction score(1- Unsatisfied, 2- Satisfied, 3- Fully Satisfied at POD 0 till Discharge)
  • Active knee extension(knee extension in degrees 0,15,30,45,90 at 6 hr,12 hr,18 hr,24 hr,36 hr,48 hr,72 hr and at Discharge)
  • Quality of Sonoimage(Best/Average/Poor)

研究者

发起方
Ganga Medical Centre and Hospitals Pvt Ltd
申办方类型
Research institution and hospital

研究点 (1)

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