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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:
ClinicalTrials.gov Identifier:
NCT00175630
First Posted: September 15, 2005
Last Update Posted: June 1, 2016
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.
Information provided by (Responsible Party):
University of British Columbia
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Postoperative morphine requirement

Secondary Outcome Measures:
  • Pain rating [ Time Frame: immediately post-op ]
  • Opioid surgical time [ Time Frame: time from end of anaesthesia to first requirement of morphine ]

Enrollment: 30
Study Start Date: December 2010
Estimated Study Completion Date: September 2016
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

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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
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): 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

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00175630     History of Changes
Other Study ID Numbers: H05-70078
W05-0024
First Submitted: September 13, 2005
First Posted: September 15, 2005
Last Update Posted: June 1, 2016
Last Verified: May 2016

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
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Bupivacaine
Analgesics, Opioid
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotics
Analgesics