Comparison of Levobupivacaine, Ropivacaine and Bupivacaine in Epidural Anaesthesia

Not Applicable

Completed

• Conditions: Pain Insensitivity, Congenital
• Interventions: Drug: Bupivacaine; Drug: Ropivacaine; Drug: Levobupivacaine

• Registration Number: NCT02513433
• Lead Sponsor: Government Medical College, Haldwani

Brief Summary

This study compares the clinical efficacy of newer local anaesthetic drugs Levobupivacaine and Ropivacaine with Bupivacaine in lumbar epidural anaesthesia for hip surgeries.

Detailed Description

Some of the most common day care surgeries are hip surgeries, in which local anaesthetic agents can be used via epidural route for both intra-op and post-op analgesia.

Among the drugs used nowadays are Lignocaine, Bupivacaine, Levobupivacaine and Ropivacaine.However Bupivacaine usage is not free from side effects.

The claimed benefits of both Levobupivacaine and Ropivacaine are reduced cardiac toxicity on overdose and more specific effects on sensory rather than motor nerve fibres.

Ropivacaine, an analog of Mepivacaine, is one of the long acting amide anaesthetic agent similar to Bupivacaine in chemical structure and anaesthetic function. It is a first enantiomer-specific compound, which has a reduced risk of cardio toxicity, neuro toxicity and rapid recovery of motor function. Levobupivacaine is the pure S (-)-enantiomer of Bupivacaine, and in recent year has emerged as a safer alternative for regional anaesthesia than its racemic parent.

Study Timeline

• Study Start: 2012-12
• Primary Completion: 2014-08
• Study Completion: 2014-09
• Status Verified: 2015-07
• Study First Submitted: 2015-07-30
• Study First Submitted QC: 2015-07-30
• Study First Posted: 2015-07-31
• Last Update Submitted: 2015-07-31
• Last Update Posted: 2015-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• ASA Grade I and II patients of either sex
• Age 18-60 years
• Undergoing various hip surgeries under lumbar epidural anesthesia

Exclusion Criteria

• Refusal for epidural
• ASA-III&IV
• Head injury
• Psychiatric disease
• Known allergic to test drugs
• Major systemic disease
• Any analgesia with in past 24 hours

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bupivacaine & Levobupivacaine	Bupivacaine	Bupivacaine 15 ml 0.5% and Levobupivacaine 15 ml 0.5% in epidural route before surgery
Bupivacaine & Ropivacaine	Ropivacaine	Bupivacaine 15 ml 0.5% and Ropivacaine 15 ml 0.75% in epidural route before surgery
Bupivacaine & Ropivacaine	Bupivacaine	Bupivacaine 15 ml 0.5% and Ropivacaine 15 ml 0.75% in epidural route before surgery
Bupivacaine & Levobupivacaine	Levobupivacaine	Bupivacaine 15 ml 0.5% and Levobupivacaine 15 ml 0.5% in epidural route before surgery
Ropivacaine & Levobupivacaine	Levobupivacaine	Ropivacaine 15 ml 0.75% and Levobupivacaine 15 ml 0.5% in epidural route before surgery
Ropivacaine & Levobupivacaine	Ropivacaine	Ropivacaine 15 ml 0.75% and Levobupivacaine 15 ml 0.5% in epidural route before surgery

Primary Outcome Measures

Name	Time	Method
Onset of sensory block	30 minutes	Time to achieve sensory block up to tenth thoracic dermatome

Secondary Outcome Measures

Name	Time	Method
Time to achieve maximum motor block	45 minutes	Time to achieve motor block of modified Bromage score
Time for 2 segment regression of sensory block	90 minutes	Time for regression of sensory block 2 segments lower than maximum blocked dermatome

Trial Locations

Locations (1)

Government Medical College; 🇮🇳 Haldwani, Uttarakhand, India