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

This study is currently recruiting participants.
Verified May 2012 by Mahidol University
Sponsor:
Information provided by (Responsible Party):
arissara iamaroon, Mahidol University
ClinicalTrials.gov Identifier:
NCT01593566
First received: May 4, 2012
Last updated: May 7, 2012
Last verified: May 2012
History of Changes
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • time to first analgesic requirement [ Time Frame: 48 hr ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • pain score scale [ Time Frame: 48 hr ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: April 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01593566

Contacts
Contact: arissara iamaroon 089-2041150 arisa21@gmail.com

Locations
Thailand
Faculty of Medicine Siriraj Hospital, Mahidol University Recruiting
Bangkok, Thailand, 10700
Contact: arissara iamaroon     089-2041150     arisa21@gmail.com    
Contact: sudkanoung surachetpong         aris_sa@hotmail.com    
Principal Investigator: arissara iamaroon            
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: arissara iamaroon Mahidol University
  More Information

No publications provided

Responsible Party: arissara iamaroon, associated professor, Mahidol University
ClinicalTrials.gov Identifier: NCT01593566     History of Changes
Other Study ID Numbers: Mahidol University
Study First Received: May 4, 2012
Last Updated: May 7, 2012
Health Authority: Thailand: Ethical Committee

Keywords provided by Mahidol University:
femoral nerve block

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

ClinicalTrials.gov processed this record on May 16, 2013