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

NCT ID: NCT00175630

Last Updated: 2016-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2016-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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Administration of a femoral nerve block (bupivacaine HCL)

See Detailed Description

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christopher Reilly, MD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

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British Columbia Children's Hospital, Department of Orthopaedics

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

Other Identifiers

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W05-0024

Identifier Type: -

Identifier Source: secondary_id

H05-70078

Identifier Type: -

Identifier Source: org_study_id

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