Comparison of Levobupivacaine, Ropivacaine and Bupivacaine in Epidural Anaesthesia

Condition(s) targeted: Pain Insensitivity, Congenital

Intervention: Bupivacaine (Drug); Levobupivacaine (Drug); Ropivacaine (Drug)

Phase: N/A

Status: Completed

Sponsored by: Government Medical College, Haldwani

Official(s) and/or principal investigator(s):
Geeta Bhandari, M.D., Principal Investigator, Affiliation: Professor and Head of the department

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

Official title: Comparative Evaluation of Newer Congeners i.e. Levobupivacaine and Ropivacaine With Bupivacaine, in Lumbar Epidural Anaesthesia for Hip Surgeries

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Supportive Care

Primary outcome: Onset of sensory block

Secondary outcome:

Time for 2 segment regression of sensory block

Time to achieve maximum motor block

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.

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

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

Government Medical College, Haldwani, Uttarakhand 263139, India

Starting date: December 2012
Last updated: July 31, 2015