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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01593566
Recruitment Status : Completed
First Posted : May 8, 2012
Last Update Posted : April 9, 2015
Sponsor:
Information provided by (Responsible Party):

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
Analgesia After ACL Reconstruction Drug: 0.25% Bupivacaine Drug: 0.5% Bupivacaine Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
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 : April 2011
Primary Completion Date : April 2013
Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: 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 Name: marcaine


Outcome Measures

Primary Outcome Measures :
  1. time to first analgesic requirement [ Time Frame: 48 hr ]

Secondary Outcome Measures :
  1. pain score scale [ Time Frame: 48 hr ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01593566


Locations
Thailand
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: arissara iamaroon Mahidol University
More Information

Responsible Party: arissara iamaroon, associated professor, Mahidol University
ClinicalTrials.gov Identifier: NCT01593566     History of Changes
Other Study ID Numbers: Mahidol University
First Posted: May 8, 2012    Key Record Dates
Last Update Posted: April 9, 2015
Last Verified: April 2015

Keywords provided by arissara iamaroon, Mahidol University:
femoral nerve block

Additional relevant MeSH terms:
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents