This trial is active, not recruiting.

Condition pain, postoperative
Treatment administration of a femoral nerve block (bupivacaine hcl)
Phase phase 1
Sponsor University of British Columbia
Start date December 2010
End date September 2011
Trial size 30 participants
Trial identifier NCT00175630, H05-70078, W05-0024


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment

Primary Outcomes

Postoperative morphine requirement
time frame: Unspecified

Secondary Outcomes

Pain rating
time frame: immediately post-op
Opioid surgical time
time frame: time from end of anaesthesia to first requirement of morphine

Eligibility Criteria

Male or female participants from 12 years up to 17 years old.

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

Additional Information

Official title Effect of Femoral Nerve Block on Opioid Requirements Following Anterior Cruciate Ligament Reconstruction: A Double Blind, Prospective Randomized Controlled Trial
Principal investigator Christopher Reilly, MD
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of British Columbia.