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临床试验/CTRI/2025/03/082493
CTRI/2025/03/082493尚未招募不适用

Comparing Variable Doses Of Dexamethasone As An Adjuvant To Levobupivacaine In Ultrasound Guided Supraclavicular Brachial Plexus Block For Patients Undergoing Orthopaedic Upper Limb Surgeries – A Prospective Study

OrthoOne Orthopaedic Speciality Centre1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2025年2月4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
58
试验地点
1
主要终点
To assess the duration of analgesia between 4 mg of dexamethasone and 6 mg of dexamethasone

研究概览

简要总结

Supraclavicular Brachial Plexus block is a good alternative to general anaesthesia for upper

limb orthopaedic surgeries. This avoids the untoward effects of general anaesthetic drugs and

upper airway instrumentation in patients.

It achieves muscle relaxation, intraoperative hemodynamic stability and post-operative analgesia and reduces the requirement of post-operative opioid usage.

Considering the pharmacological profile of Bupivacaine, its clinical efficacy, long duration of action and favourable ratio of sensory to motor block it is used most frequently among local anaesthetics for brachial plexus block. However its major disadvantage is cardiotoxicity, primarily triggered by its dextrogyrous enantiomer

Levobupivacaine, a pure S- enantiomer of Bupivacaine has potentially reduced toxic profile compared to Bupivacaine. Levobupivacaine is a better drug for regional block due to its low cardiotoxic profile compared to Bupivacaine. Levobupivacaine’s efficacy proved similar or greater than Bupivacaine in regional blocks and could be used more safely in ASA grade 3 and 4 patients and cardiac patients in whom general anaesthesia is risky.

Peripheral nerve blocks with local anaesthetics provide excellent operating conditions,

facilitate early mobilisation and bypass the post anaesthesia care unit, but duration of

analgesia is rarely maintained for more than 4-8 hours even with the longest acting local

anaesthetics.

Perineural catheters can improve duration of analgesia from local anaesthetics but carry

problems of catheter migration, pump malfunction, leakage, etc.

Therefore, many adjuvants are added to the local anaesthetic in single shot regional

technique with variable results. Different drugs have been used as adjuvants with local

anaesthetics in brachial plexus block to achieve a quick, dense and prolonged block.

Various studies have shown that addition of corticosteroid dexamethasone, as a non

particulate injection, to local anaesthetics prolongs duration of blockade by approximately

8-10 hours in peripheral nerves.

However, the administration of dexamethasone is not risk free and concerns have been raised

regarding hyperglycaemia and surgical site infection. These adverse effects are likely to be

dose dependent. Owing to the potential toxicity concern, it may be beneficial to use lower

doses of dexamethasone, if these provide similar increase in analgesia duration compared to

higher doses

The purpose of this study is to compare the effectiveness, duration and quality of motor

blockade and sensory blockade between patients receiving of two relatively low doses (4 mg

and 6 mg) of dexamethasone, used as adjuvant to 0.25% levobupivacaine, for supraclavicular

brachial plexus block in patients undergoing upper limb orthopaedic surgeries

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 80.00 Year(s)(—)
性别
All

入选标准

  • Elective and Emergency Orthopaedic Upper limb surgeries ASA I , II and III.

排除标准

  • 未提供

结局指标

主要结局

To assess the duration of analgesia between 4 mg of dexamethasone and 6 mg of dexamethasone

时间窗: 0 hours , 2 hours , 4 hours , 8 hours , 12 hours , 24 hours

added to levobupivacaine

时间窗: 0 hours , 2 hours , 4 hours , 8 hours , 12 hours , 24 hours

次要结局

  • To assess the Intensity of pain , Haemodynamic status of patients over 24 hours(0 hours to 24 hours)
  • To assess the time taken for onset of sensory & motor block(0 mins , 2 mins , 4 mins , 6 mins , 8 mins , 10 mins , 12 mins , 14 mins , 15 mins)
  • To assess the total requirement of rescue analgesia over a period of 24 hours post-(operatively)

研究者

发起方
OrthoOne Orthopaedic Speciality Centre
申办方类型
Private hospital/clinic

研究点 (1)

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