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

This study has been completed.
Information provided by (Responsible Party):
arissara iamaroon, Mahidol University
ClinicalTrials.gov Identifier:
First received: May 4, 2012
Last updated: April 8, 2015
Last verified: April 2015
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:

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 ]

Enrollment: 100
Study Start Date: April 2011
Study Completion Date: June 2013
Primary Completion Date: April 2013 (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


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

Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
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 
Study First Received: May 4, 2012
Last Updated: April 8, 2015
Health Authority: Thailand: Ethical Committee

Keywords provided by Mahidol University:
femoral nerve block

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

ClinicalTrials.gov processed this record on May 22, 2016