Comparison of Levobupivacaine, Ropivacaine and Bupivacaine in Epidural Anaesthesia

Pain Insensitivity, Congenital Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02513433
• Other study ID #: 65/IEC/01/12-13
• Status: Completed
• Phase: N/A
• First received: July 30, 2015
• Last updated: July 31, 2015
• Start date: December 2012
• Est. completion date: September 2014

Study information

• Verified date: July 2015
• Source: Government Medical College, Haldwani
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Indian Council of Medical Research
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Pain Insensitivity, Congenital

Intervention

Drug:
• Bupivacaine
Local anesthetic
• Levobupivacaine
Local anesthetic
• Ropivacaine
Local anesthetic

Locations

Country	Name	City	State
India	Government Medical College	Haldwani	Uttarakhand

Sponsors (1)

Lead Sponsor	Collaborator
Government Medical College, Haldwani

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Onset of sensory block	Time to achieve sensory block up to tenth thoracic dermatome	30 minutes	No
Secondary	Time for 2 segment regression of sensory block	Time for regression of sensory block 2 segments lower than maximum blocked dermatome	90 minutes	No
Secondary	Time to achieve maximum motor block	Time to achieve motor block of modified Bromage score	45 minutes	No