Femoral Nerve Block for Analgesia After Anterior Cruciate Ligament Reconstruction

NCT ID: NCT01593566

Last Updated: 2015-04-09

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

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2013-06-30

Brief Summary

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Femoral nerve block using 0.25% bupivacaine or 0.5% bupivacaine provides a longer time for analgesia after Anterior Cruciate Ligament (ACL) reconstruction.

Detailed Description

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Conditions

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Analgesia After ACL Reconstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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0.25% bupivacaine

femoral nerve block using 0.25% bupivacaine versus 0.5% bupivacaine

Group Type ACTIVE_COMPARATOR

0.25% Bupivacaine

Intervention Type DRUG

Femoral nerve block using 0.25% versus 0.5% bupivacaine

0.5% bupivacaine

femoral nerve block using 0.25% bupivacaine versus 0.5% bupivacaine

Group Type ACTIVE_COMPARATOR

0.5% Bupivacaine

Intervention Type DRUG

Femoral nerve block using 0.25% versus 0.5% bupivacaine for analgesia after ACL reconstruction

Interventions

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0.25% Bupivacaine

Femoral nerve block using 0.25% versus 0.5% bupivacaine

Intervention Type DRUG

0.5% Bupivacaine

Femoral nerve block using 0.25% versus 0.5% bupivacaine for analgesia after ACL reconstruction

Intervention Type DRUG

Other Intervention Names

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marcaine marcaine

Eligibility Criteria

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Inclusion Criteria

* Patients scheduled for ACL reconstruction
* ASA physical status I-II
* Body weight \> or = 50 kg.

Exclusion Criteria

* Patients with redo ACL reconstruction
* Contraindication to neuraxial block
* allergy to local anesthetics, sulfa, NSAIDs, morphine, paracetamol
* Patients with communication problem
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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arissara iamaroon

associated professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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arissara iamaroon

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

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Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, , Thailand

Site Status

Countries

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Thailand

Other Identifiers

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Mahidol University

Identifier Type: -

Identifier Source: org_study_id

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