Clincosm LogoSign in Get a demo

Comparison of Levobupivacaine, Ropivacaine and Bupivacaine in Epidural Anaesthesia

Sponsor
Government Medical College, Haldwani (Other)
Overall Status
Completed
CT.gov ID
NCT02513433
Collaborator
(none)
90
Enrollment
1
Location
3
Arms
21
Duration (Months)
4.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Supportive Care
Official Title:
Comparative Evaluation of Newer Congeners i.e. Levobupivacaine and Ropivacaine With Bupivacaine, in Lumbar Epidural Anaesthesia for Hip Surgeries
Study Start Date :
Dec 1, 2012
Actual Primary Completion Date :
Aug 1, 2014
Actual Study Completion Date :
Sep 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Bupivacaine & Levobupivacaine

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

Drug: Bupivacaine
Local anesthetic
Other Names:
  • Anawin
  • Sensorcaine

    • Drug: Levobupivacaine
    Local anesthetic
    Other Names:
  • Levo-anawin

    		•
    Active Comparator: Bupivacaine & Ropivacaine

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

    Drug: Bupivacaine
    Local anesthetic
    Other Names:
  • Anawin
  • Sensorcaine

    • Drug: Ropivacaine
    Local anesthetic
    Other Names:
  • Ropin

    		•
    Active Comparator: Ropivacaine & Levobupivacaine

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

    Drug: Levobupivacaine
    Local anesthetic
    Other Names:
  • Levo-anawin

    • Drug: Ropivacaine
    Local anesthetic
    Other Names:
  • Ropin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Onset of sensory block [30 minutes]

      Time to achieve sensory block up to tenth thoracic dermatome

    Secondary Outcome Measures

    1. Time for 2 segment regression of sensory block [90 minutes]

      Time for regression of sensory block 2 segments lower than maximum blocked dermatome

    2. Time to achieve maximum motor block [45 minutes]

      Time to achieve motor block of modified Bromage score

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Government Medical College Haldwani Uttarakhand India 263139

    Sponsors and Collaborators

    • Government Medical College, Haldwani

    Investigators

    • Principal Investigator: Geeta Bhandari, M.D., Professor and Head of the department

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr Subhro Mitra, Assistant Professor, Government Medical College, Haldwani
    ClinicalTrials.gov Identifier:
    NCT02513433
    Other Study ID Numbers:
    • 65/IEC/01/12-13
    First Posted:
    Jul 31, 2015
    Last Update Posted:
    Aug 4, 2015
    Last Verified:
    Jul 1, 2015
    Keywords provided by Dr Subhro Mitra, Assistant Professor, Government Medical College, Haldwani
    Lumbar epidural anaesthesia
    Additional relevant MeSH terms:
    Pain Insensitivity, Congenital
    Bupivacaine
    Ropivacaine
    Levobupivacaine

    Study Results

    No Results Posted as of Aug 4, 2015