Comparison of Levobupivacaine, Ropivacaine and Bupivacaine in Epidural Anaesthesia

NCT ID: NCT02513433

Last Updated: 2015-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2014-09-30

Brief Summary

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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

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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.

Conditions

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Pain Insensitivity, Congenital

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Bupivacaine & Levobupivacaine

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

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

Local anesthetic

Levobupivacaine

Intervention Type DRUG

Local anesthetic

Bupivacaine & Ropivacaine

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

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

Local anesthetic

Ropivacaine

Intervention Type DRUG

Local anesthetic

Ropivacaine & Levobupivacaine

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

Group Type ACTIVE_COMPARATOR

Levobupivacaine

Intervention Type DRUG

Local anesthetic

Ropivacaine

Intervention Type DRUG

Local anesthetic

Interventions

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Bupivacaine

Local anesthetic

Intervention Type DRUG

Levobupivacaine

Local anesthetic

Intervention Type DRUG

Ropivacaine

Local anesthetic

Intervention Type DRUG

Other Intervention Names

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Anawin Sensorcaine Levo-anawin Ropin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Government Medical College, Haldwani

OTHER

Sponsor Role lead

Responsible Party

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Dr Subhro Mitra

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Geeta Bhandari, M.D.

Role: PRINCIPAL_INVESTIGATOR

Professor and Head of the department

Locations

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Government Medical College

Haldwani, Uttarakhand, India

Site Status

Countries

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India

Other Identifiers

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65/IEC/01/12-13

Identifier Type: -

Identifier Source: org_study_id

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