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临床试验/CTRI/2022/11/047461
CTRI/2022/11/047461尚未招募不适用

Comparison of two doses of dexmedetomidine as adjuvent to 0.5% Ropivacaine in ultrasound guided brachial plexus block in upper limb surgeries-A Randomised Control Trail

Rohilkhand Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年11月24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
Onset of motor block and duration of motor block

研究概览

简要总结

In today’s world brachial plexus block has evolved as an important part of dailyroutine anaesthesiology practice as an substitute to general anaesthesia for upper limb surgeries. This mode of anaesthesia is also considered safe due to its application with an ultrasound guided live imaging. Also, it aids patient in form of providing post operative analgesia and reducing hospital stay that helps patient financially also.

The first supraclavicular block was performed in 1912 by kulen kampff byconventional parasthesia technique blind technique. Giving regional anaesthesia by blind technique has an high failure risk and risk of damaging vital anatomical structures. Ultrasound guided regional anaesthesia eliminates this drawback of blind technique.2 In 1978 La Grange introduced application of doppler probe to identify arteries .

In regional anaesthesia we use a local anaesthesia that is used to block the brachialplexus. These local anaesthetics have limited duration of action and providing post operativeanalgesia. Ropivacaine being a long acting amino amide is one of foremost drug used inbrachial plexus block. Ropivacaine when compared with bupivacaine and levobupivacainehas lower lipid solubility and hence provide greater sensory and motor blockade duration and also motor function recovery is fast.

Ropivacaine when compared with other local anaesthetic like bupivacaine and levobupivacaine is less cardiac and central nervous system toxic drug. It acts on voltage gatedsodium channels that blocks peripheral afferents.

Even with use of Ropivacaine it was found that duration of analgesia was limited andpatients complained of post operative pain and opiod administration was required to prolongpost operative analgesia duration. So use of adjuvents with  local anaesthetic came into existence such as dexmedetomidine, clonidine, opioids and neostigmine. These helped toprolong post operative analgesia. Opioids are known to cause various side effects like apnea,respiratory suppression, hypoxia so dexmedetomidine provides anaesthesiologists with abetter alternative to opoids and helps to elinminates these side effets.

Dexmedetomidine is an alpha 2 receptor blocker agonist that can be used as anadjuvent to local anaesthetic in order to prolong duration of post operative analgesia and to decrease time of onset . Dexmedetomidine has analgesic, sedative antihypertensive and anaesthetic sparing properties that contributes multimodaly. Dexmedetomidine as alpha 2agonist is highly selective (more than 8 times selective as compared to clonidine ) as an adjuvant.

Previous studies are present that have compared various local anaesthetics alone andwith combination with adjuvents in brachial plexus blocks for upper limb surgeriesindividually. To our comprehension few study are known to have compared effects ofropivacaine in regional anaesthesia in brachial plexus block in combination with two differentdosages of dexmedetomidine, and access results of these two groups.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • American society of Anesthesiologist (ASA) grade I or II Posted for surgery of upper limb under ultrasound guided brachial plexus block.

排除标准

  • Refusal by patient Patients taking anticoagulants, β- blockers or opioids, psychotropic medication.
  • Patients with history of significant​neurological, psychiatric, neuromuscular, cardiovascular, pulmonary, renal or hepatic disease.
  • Patients having history of drug and alcohol abuse.
  • Patients with contraindication to Ropivacaine and dexmedetomidine.
  • Women with pregnancy or lactating women.
  • Patients on chronic analgesic therapy, diabetes or having coagulation disorders.
  • Patient with infection at site of injection.

结局指标

主要结局

Onset of motor block and duration of motor block

时间窗: The patient will be evaluated for sensory and motor block for every 2 minutes for first 20 minutes every 3 minutes for next 30 minutes, every 10 minutes for 60 minutes and finally every 15 minutes until the sensory and motor block regresses

Onset of sensory block and duration of sensory block

时间窗: The patient will be evaluated for sensory and motor block for every 2 minutes for first 20 minutes every 3 minutes for next 30 minutes, every 10 minutes for 60 minutes and finally every 15 minutes until the sensory and motor block regresses

Duration of postoperative analgesia

时间窗: The patient will be evaluated for sensory and motor block for every 2 minutes for first 20 minutes every 3 minutes for next 30 minutes, every 10 minutes for 60 minutes and finally every 15 minutes until the sensory and motor block regresses

次要结局

  • Hemodynamic responses to the drug during and after surgery.

研究者

发起方
Rohilkhand Medical College and Hospital
申办方类型
Private medical college

研究点 (1)

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