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Comparison of Levobupivacaine, Ropivacaine and Bupivacaine in Epidural Anaesthesia

Primary Purpose

Pain Insensitivity, Congenital

Status

Completed

Phase

Not Applicable

Locations

India

Study Type

Interventional

Intervention

Bupivacaine

Levobupivacaine

Ropivacaine

About this trial

This is an interventional supportive care trial for Pain Insensitivity, Congenital focused on measuring Lumbar epidural anaesthesia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Government Medical College

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Bupivacaine & Levobupivacaine

Bupivacaine & Ropivacaine

Ropivacaine & Levobupivacaine

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Onset of sensory block

Time to achieve sensory block up to tenth thoracic dermatome

Secondary Outcome Measures

Time for 2 segment regression of sensory block

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

Time to achieve maximum motor block

Time to achieve motor block of modified Bromage score

Full Information

NCT ID

NCT02513433

First Posted

July 30, 2015

Last Updated

July 31, 2015

Sponsor

Government Medical College, Haldwani

1. Study Identification

Unique Protocol Identification Number

NCT02513433

Brief Title

Comparison of Levobupivacaine, Ropivacaine and Bupivacaine in Epidural Anaesthesia

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Completed

Study Start Date

December 2012 (undefined)

Primary Completion Date

August 2014 (Actual)

Study Completion Date

September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Government Medical College, Haldwani

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain Insensitivity, Congenital

Keywords

Lumbar epidural anaesthesia

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bupivacaine & Levobupivacaine

Arm Type

Active Comparator

Arm Description

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

Arm Title

Bupivacaine & Ropivacaine

Arm Type

Active Comparator

Arm Description

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

Arm Title

Ropivacaine & Levobupivacaine

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Bupivacaine

Other Intervention Name(s)

Anawin, Sensorcaine

Intervention Description

Local anesthetic

Intervention Type

Drug

Intervention Name(s)

Levobupivacaine

Other Intervention Name(s)

Levo-anawin

Intervention Description

Local anesthetic

Intervention Type

Drug

Intervention Name(s)

Ropivacaine

Other Intervention Name(s)

Ropin

Intervention Description

Local anesthetic

Primary Outcome Measure Information:

Title

Onset of sensory block

Description

Time to achieve sensory block up to tenth thoracic dermatome

Time Frame

30 minutes

Secondary Outcome Measure Information:

Title

Time for 2 segment regression of sensory block

Description

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

Time Frame

90 minutes

Title

Time to achieve maximum motor block

Description

Time to achieve motor block of modified Bromage score

Time Frame

45 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Geeta Bhandari, M.D.

Organizational Affiliation

Professor and Head of the department

Official's Role

Principal Investigator

Facility Information:

Facility Name

Government Medical College

City

Haldwani

State/Province

Uttarakhand

ZIP/Postal Code

263139

Country

India

12. IPD Sharing Statement

Learn more about this trial

Comparison of Levobupivacaine, Ropivacaine and Bupivacaine in Epidural Anaesthesia

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