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临床试验/CTRI/2020/07/026467
CTRI/2020/07/026467已完成4 期

Efficacy of Dexmedetomidine as an adjuvant to 0.25% Bupivacaine in Ultrasound guided Femoral Nerve Block for Pre-operative positioning and Post-operative Analgesia in patients undergoing elective surgery for Femoral shaft fracture

Vijayanagara Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2020年7月20日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
70
试验地点
1
主要终点
To determine patient comfort for positioning for spinal anaesthesia and Duration of post operative analgesia

研究概览

简要总结

FemoralNerve Block,(FNB) a type ofregional anaesthesia providesfor reduction in pain intensity in the Peri-operative period allowing for easypositioningandextending analgesia postoperatively, thereby reducing the need for opioids.

Various adjuvant drugs suchas epinephrine, opioids, Sodium Bicarbonate,midazolam, ketamine, and neostigmine have been evaluated in conjunction withlocal anesthetics to prolong the duration of analgesia, but they were found tobe either ineffective or to produce an unacceptably high incidence of adverse effects.

Dexmedetomidine isa selective α2 adrenoceptor agonist has an Analgesic, Anaesthetic sparing effect, Symphatholytic, Sedative, Cardiovascular stabilizing property. Not many studies have been performed using it as an adjuvant to femoral nerve block, hence a study to know its effectiveness as an adjuvant is being planned.

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 70.00 Year(s)(—)
性别
All

入选标准

  • ASA Grade I & II.

排除标准

  • 1 Allergy to Study Drug 2 History of significant systemic disease ( n Cardiovascular, Respiratory, Central Nervous System, Renal System ) 3 Cognitive Dysfunction 4 Emergency Surgeries 5 Patients with Spinal Deformities, Bleeding Diasthesis 6 Local Skin Site Infection 7 Refusal by patients for procedure.

结局指标

主要结局

To determine patient comfort for positioning for spinal anaesthesia and Duration of post operative analgesia

时间窗: From start of procedure until 24 hrs post operative

次要结局

  • 1 Onset, Duration, Level of sensory Block(2 Onset, Duration of motor Block)

研究者

发起方
Vijayanagara Institute of Medical Sciences
申办方类型
Government medical college

研究点 (1)

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