Spinal Anaesthesia With Levobupivacaine 0.5% and Ropivacaine 0.75% for Lower Limb Orthopaedic Surgery

NCT ID: NCT02201784

Last Updated: 2015-01-21

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2014-01-31

Brief Summary

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The purpose of this study is to compare the effects of two intrathecally administered drugs:0.5% levobupivacaine and0.75%Ropivacaine in spinal anesthesia

Detailed Description

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Bupivacaine is a highly cardiotoxic drug and also produces prolonged motor blockade.The newer drugs levobupivacaine and ropivacaine being comparatively less cardio and neurotoxic are preferred now a days.So, we conducted this prospective, randomized double blind study with an aim of comparing the efficacy and characteristics of these drugs.

Conditions

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Lower Limb Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Levobupivacaine 0.5%

intrathecal administration of 15 mg of Levobupivacaine 0.5%

Group Type ACTIVE_COMPARATOR

Levobupivacaine

Intervention Type DRUG

Comparison of Equipotent doses

Ropivacaine 0.75%

intrathecal administration of 22.5 mg of Ropivacaine 0.75%

Group Type ACTIVE_COMPARATOR

Ropivacaine

Intervention Type DRUG

Comparison of equipotent doses

Interventions

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Levobupivacaine

Comparison of Equipotent doses

Intervention Type DRUG

Ropivacaine

Comparison of equipotent doses

Intervention Type DRUG

Other Intervention Names

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Chirocaine Naropin

Eligibility Criteria

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Inclusion Criteria

1. American Society of Anesthesiologists (ASA) class I \& II patients of either sex
2. Age between 18-60 years

Exclusion Criteria

1. Patient's refusal.
2. Patients who have contraindications to spinal anaesthesia / Local anaesthetic drugs.
3. Patients having h/o diabetes, neurological and musculoskeletal diseases.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aligarh Muslim University

OTHER

Sponsor Role lead

Responsible Party

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MANAZIR ATHAR

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Manazir Athar, M.D

Role: PRINCIPAL_INVESTIGATOR

Jawaharlal Nehru Medical College, AMU,Aligarh, India

Syed Moied Ahmed, PhD, M.D

Role: STUDY_DIRECTOR

Jawaharlal Nehru Medical College, AMU, Aligarh, India

Masood H Siddiqi, M.S

Role: STUDY_DIRECTOR

Jawaharlal Nehru Medical College, AMU, Aligarh, India

Locations

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Jawaharlal Nehru medical college, AMU

Aligarh, Uttar Pradesh, India

Site Status

Countries

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India

Other Identifiers

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jnmch2012

Identifier Type: -

Identifier Source: org_study_id

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