Comparison of Levobupivacaine, Ropivacaine and Bupivacaine in Epidural Anaesthesia

Government Medical College, Haldwani

Status: Completed

Conditions: Pain Insensitivity, Congenital

Treatments: Drug: Bupivacaine; Drug: Ropivacaine; Drug: Levobupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02513433

65/IEC/01/12-13

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups

Bupivacaine & Levobupivacaine

Active Comparator group

Description:

Bupivacaine 15 ml 0.5% and Levobupivacaine 15 ml 0.5% in epidural route before surgery

Treatment:

Drug: Levobupivacaine

Drug: Bupivacaine

Bupivacaine & Ropivacaine

Active Comparator group

Description:

Bupivacaine 15 ml 0.5% and Ropivacaine 15 ml 0.75% in epidural route before surgery

Treatment:

Drug: Ropivacaine

Drug: Bupivacaine

Ropivacaine & Levobupivacaine

Active Comparator group

Description:

Ropivacaine 15 ml 0.75% and Levobupivacaine 15 ml 0.5% in epidural route before surgery

Treatment:

Drug: Levobupivacaine

Drug: Ropivacaine