search
Back to results

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

Primary Purpose

Pain, Postoperative

Status
Unknown status
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Administration of a femoral nerve block (bupivacaine HCL)
Sponsored by
University of British Columbia
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring ACL reconstruction, morphine sparing, preemptive analgesia, Post-operative pain and post- operative opioid use

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • British Columbia Children's Hospital, Department of Orthopaedics

Outcomes

Primary Outcome Measures

Postoperative morphine requirement

Secondary Outcome Measures

Pain rating
Opioid surgical time

Full Information

First Posted
September 13, 2005
Last Updated
May 30, 2016
Sponsor
University of British Columbia
search

1. Study Identification

Unique Protocol Identification Number
NCT00175630
Brief Title
The Effect of Femoral Nerve Block on Postoperative Opioid Use After Anterior Cruciate Ligament (ACL) Reconstruction
Official Title
Effect of Femoral Nerve Block on Opioid Requirements Following Anterior Cruciate Ligament Reconstruction: A Double Blind, Prospective Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of British Columbia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
ACL reconstruction, morphine sparing, preemptive analgesia, Post-operative pain and post- operative opioid use

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Administration of a femoral nerve block (bupivacaine HCL)
Intervention Description
See Detailed Description
Primary Outcome Measure Information:
Title
Postoperative morphine requirement
Secondary Outcome Measure Information:
Title
Pain rating
Time Frame
immediately post-op
Title
Opioid surgical time
Time Frame
time from end of anaesthesia to first requirement of morphine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Reilly, MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
British Columbia Children's Hospital, Department of Orthopaedics
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3V4
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs