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FNB for ACLR: Femoral Nerve Block for Analgesia After Anterior Cruciate Ligament Reconstruction

Sponsor
Mahidol University (Other)
Overall Status
Completed
CT.gov ID
NCT01593566
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
26
Duration (Months)
3.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: 0.25% Bupivacaine
  • Drug: 0.5% Bupivacaine
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Femoral Nerve Block Using 0.25% Versus 0.5% Bupivacaine for Analgesia After Arthroscopic Anterior Cruciate Ligament Reconstruction
Study Start Date :
Apr 1, 2011
Actual Primary Completion Date :
Apr 1, 2013
Actual Study Completion Date :
Jun 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 0.25% bupivacaine

femoral nerve block using 0.25% bupivacaine versus 0.5% bupivacaine

Drug: 0.25% Bupivacaine
Femoral nerve block using 0.25% versus 0.5% bupivacaine
Other Names:
  • marcaine

    		•
    Active Comparator: 0.5% bupivacaine

    femoral nerve block using 0.25% bupivacaine versus 0.5% bupivacaine

    Drug: 0.5% Bupivacaine
    Femoral nerve block using 0.25% versus 0.5% bupivacaine for analgesia after ACL reconstruction
    Other Names:
  • marcaine

    		•

    Outcome Measures

    Primary Outcome Measures

    1. time to first analgesic requirement [48 hr]

    Secondary Outcome Measures

    1. pain score scale [48 hr]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Medicine Siriraj Hospital, Mahidol University Bangkok Thailand 10700

    Sponsors and Collaborators

    • Mahidol University

    Investigators

    • Principal Investigator: arissara iamaroon, Mahidol University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    arissara iamaroon, associated professor, Mahidol University
    ClinicalTrials.gov Identifier:
    NCT01593566
    Other Study ID Numbers:
    • Mahidol University
    First Posted:
    May 8, 2012
    Last Update Posted:
    Apr 9, 2015
    Last Verified:
    Apr 1, 2015
    Keywords provided by arissara iamaroon, associated professor, Mahidol University
    femoral nerve block
    Additional relevant MeSH terms:
    Agnosia
    Bupivacaine

    Study Results

    No Results Posted as of Apr 9, 2015