Comparing two doses of dexamethasone in addition to Levobupivacaine in Supraclavicular Brachial Plexus Block for Upper limb Orthopaedic Surgeries

Not yet recruiting

Conditions: Unspecified fracture of wrist andhand,

Registration Number: CTRI/2025/03/082493

Lead Sponsor: OrthoOne Orthopaedic Speciality Centre

Brief Summary: 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

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 58

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the duration of analgesia between 4 mg of dexamethasone and 6 mg of dexamethasone	0 hours , 2 hours , 4 hours , 8 hours , 12 hours , 24 hours
added to levobupivacaine	0 hours , 2 hours , 4 hours , 8 hours , 12 hours , 24 hours

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1): Ortho-One Orthopaedic Speciality Centre
🇮🇳
Coimbatore, TAMIL NADU, India
Ortho-One Orthopaedic Speciality Centre
🇮🇳Coimbatore, TAMIL NADU, India
Ashwin Suuraj
Principal investigator
8754026064
ashwinsuuraj55@gmail.com