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

This study is not yet open for participant recruitment.

Verified by University of British Columbia, September 2008

First Received: September 13, 2005 Last Updated: September 23, 2008 History of Changes

Sponsored by:	University of British Columbia
Information provided by:	University of British Columbia
ClinicalTrials.gov Identifier:	NCT00175630

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 I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
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:

Drug Information available for: Bupivacaine hydrochloride Bupivacaine

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 ]

Estimated Enrollment:	50
Study Start Date:	December 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Intervention Details:

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

Contacts

Contact: Bronwyn Tritt

604-875-2359

btritt@cw.bc.ca

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 ( Dr. Christopher Reilly )
Study ID Numbers:	C05-0078, W05-0024
Study First Received:	September 13, 2005
Last Updated:	September 23, 2008
ClinicalTrials.gov Identifier:	NCT00175630 History of Changes
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

Study placed in the following topic categories:

Morphine
Signs and Symptoms
Postoperative Complications
Central Nervous System Depressants
Anesthetics
Bupivacaine

Pain
Peripheral Nervous System Agents
Analgesics
Anesthetics, Local
Analgesics, Opioid
Pain, Postoperative

Additional relevant MeSH terms:

Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Pain
Anesthetics, Local
Pharmacologic Actions
Signs and Symptoms
Pathologic Processes
Postoperative Complications

Sensory System Agents
Therapeutic Uses
Bupivacaine
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Pain, Postoperative
Analgesics, Opioid

ClinicalTrials.gov processed this record on September 02, 2009