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

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: 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 Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 30, 2015