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

Pain, Postoperative Clinical Trial

Official title:

Effect of Femoral Nerve Block on Opioid Requirements Following Anterior Cruciate Ligament Reconstruction: A Double Blind, Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00175630
• Other study ID #: H05-70078
• Secondary ID: W05-0024
• Status: Active, not recruiting
• Phase: Phase 1
• First received: September 13, 2005
• Last updated: May 30, 2016
• Start date: December 2010
• Est. completion date: September 2016

Study information

• Verified date: May 2016
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: September 2016
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Procedure:
• Administration of a femoral nerve block (bupivacaine HCL)
See Detailed Description

Locations

Country	Name	City	State
Canada	British Columbia Children's Hospital, Department of Orthopaedics	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative morphine requirement		Unspecified	No
Secondary	Pain rating		immediately post-op	No
Secondary	Opioid surgical time		time from end of anaesthesia to first requirement of morphine	No