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Clinical Trials/NCT02513433
NCT02513433
Completed
Not Applicable

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

Government Medical College, Haldwani1 site in 1 country90 target enrollmentDecember 2012

Overview

Phase
Not Applicable
Intervention
Bupivacaine
Conditions
Pain Insensitivity, Congenital
Sponsor
Government Medical College, Haldwani
Enrollment
90
Locations
1
Primary Endpoint
Onset of sensory block
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2012
End Date
September 2014
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Government Medical College, Haldwani
Responsible Party
Principal Investigator
Principal Investigator

Dr Subhro Mitra

Assistant Professor

Government Medical College, Haldwani

Eligibility 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

Arms & Interventions

Bupivacaine & Levobupivacaine

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

Intervention: Bupivacaine

Bupivacaine & Levobupivacaine

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

Intervention: Levobupivacaine

Bupivacaine & Ropivacaine

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

Intervention: Bupivacaine

Bupivacaine & Ropivacaine

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

Intervention: Ropivacaine

Ropivacaine & Levobupivacaine

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

Intervention: Levobupivacaine

Ropivacaine & Levobupivacaine

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

Intervention: Ropivacaine

Outcomes

Primary Outcomes

Onset of sensory block

Time Frame: 30 minutes

Time to achieve sensory block up to tenth thoracic dermatome

Secondary Outcomes

  • Time to achieve maximum motor block(45 minutes)
  • Time for 2 segment regression of sensory block(90 minutes)

Study Sites (1)

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