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临床试验/CTRI/2023/03/050377
CTRI/2023/03/050377尚未招募不适用

EVALUATION OF THE EFFECT OF DEXMEDETOMIDINE AS ADJUVANT TO ROPIVACAINE IN ULTRASOUND GUIDED POPLITEAL SCIATIC NERVE BLOCK IN BELOW KNEE SURGERY-A ONE YEAR HOSPITAL BASED DOUBLE BLIND RANDOMIZED CLINICAL TRIALâ€

Hridya VN1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年6月3日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
To evaluate the effect of Dexmedetomidine as adjuvant to Ropivacine in ultrasound guided Popliteal Sciatic nerve block in below knee surgery.

研究概览

简要总结

The popliteal sciatic nerve block is a form of regional anesthesia used for surgeries below the knee.

Profound analgesia during both the operative and post-operative time periods and the avoidance of systemic complications are also potential benefits of the popliteal nerve block.It is also beneficial in medically compromised patients.¹

Regional anaesthesia with long-acting local anaesthetics (LAs), such as ropivacaine, is beneficial for effective postoperative pain control, but the duration of sensory block is still not sufficient to avoid the postoperative use of opioids. Perineural catheters and continuous infusion are an effective alternative to prolong the analgesic effects, but they can present challenges related to patient management, catheter displacement and the potential for increased infection risk.So the use of adjuvants, such as adrenaline, clonidine, opioid and steroids, with local anaesthetics for early onset and for prolonging the duration of blocks has been practiced for many years and remains the subject of much interest.²

Dexmedetomidine, a highly selective alpha-2 adrenergic receptor agonist that has an alpha-2 to alpha-1 selectivity ratio 7 times greater than that of clonidine, has recently been investigated for its analgesic effects and has the potential to become an alternative to clonidine. Dexmedetomidine seems to exhibit synergism with local anaesthetics, prolonging their duration of action.

The clinical evidence for the use of dexmedetomidine as an adjuvant to local anaesthetic for peripheral nerve blocks was limited to few animal and human studies. Many trials of dexmedetomidine as adjuvant to local anaesthetics in Brachial plexus block,TAP block,Femoral block etc have been published,thus prompting a re-examination specifically to assess the role of dexmedetomidine in prolonging the action of Ropivacaine in Popliteal block.³

So in this randomized study,we want to evaluate the effect of Dexmedetomidine in  onset and duration of sensory and motor block as adjuvant to Ropivacaine in popliteal sciatic nerve block.Also its effect on hemodynamic parameters and Post operative pain relief will be studied.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Double Blind Double Dummy

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • 1.ASA grade I,II and III 2.Age between 18-70years undergoing Below knee surgry.

排除标准

  • Patient refusal.
  • ASA grade IV or more 3)History of any Allergy to study drug.
  • Any contraindication for regional anaesthesia 5)Infection at intended site of injection 6)Pregnant patients.

结局指标

主要结局

To evaluate the effect of Dexmedetomidine as adjuvant to Ropivacine in ultrasound guided Popliteal Sciatic nerve block in below knee surgery.

时间窗: 1st 24 hours post surgery

次要结局

  • To determine the effect on intraoperative hemodynamic parameters.(To determine the time to 1st dose of analgesic in the postoperative period.)

研究者

发起方
Hridya VN
申办方类型
Other [self]

研究点 (1)

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