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The Effect of Femoral Nerve Block on Postoperative Opioid Use After Anterior Cruciate Ligament (ACL) Reconstruction

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00175630
First received: September 13, 2005
Last updated: September 25, 2012
Last verified: September 2012
History of Changes
  Purpose

This study evaluates the effect of a femoral nerve block on opioid requirements following anterior cruciate ligament (ACL) reconstruction. This is a double blind, prospective randomized controlled trial.


Condition Intervention Phase
Pain, Postoperative
 Procedure: Administration of a femoral nerve block (bupivacaine HCL)
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Femoral Nerve Block on Opioid Requirements Following Anterior Cruciate Ligament Reconstruction: A Double Blind, Prospective Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Postoperative morphine requirement [ Time Frame: Unspecified ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain rating [ Time Frame: immediately post-op ] [ Designated as safety issue: No ]
  • Opioid surgical time [ Time Frame: time from end of anaesthesia to first requirement of morphine ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: December 2010
Estimated Study Completion Date: April 2013
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Administration of a femoral nerve block (bupivacaine HCL)
    See Detailed Description
  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Schedule for primary elective anterior cruciate ligament reconstruction
  • Tolerance to bupivacaine
  • Tolerance to non-steroidal anti-inflammatory drugs (NSAIDs)
  • Informed consent

Exclusion Criteria:

  • Patients who received a femoral nerve block more than 1 hour prior to surgery
  • Complex associated injuries or pre-existing conditions that will delay time to ambulation
  • Children with tibial avulsion fractures
  • Allergic and/or sensitive to bupivacaine and/or NSAIDs
  • 30% over ideal body weight
  • Acute ACL reconstruction (done less than 2 weeks after injury)
  • Pre-existing femoral nerve injury
  • Psychiatric patients on psychotropic agents
  • History of drug or alcohol dependence or recreational drug use
  • Refusal to provide informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00175630

Locations
Canada, British Columbia
British Columbia Children's Hospital, Department of Orthopaedics
Vancouver, British Columbia, Canada, V6H 3V4
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Christopher Reilly, MD University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00175630     History of Changes
Other Study ID Numbers: H05-70078, W05-0024
Study First Received: September 13, 2005
Last Updated: September 25, 2012
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
ACL reconstruction
morphine sparing
preemptive analgesia
Post-operative pain and post- operative opioid use

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Bupivacaine
Analgesics, Opioid
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
Analgesics

ClinicalTrials.gov processed this record on May 23, 2013