Efficacy Study of Femoral Nerve Block in Children With a Femur Fracture

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2014-10-08

Brief Summary

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The purpose of this study is to examine the efficacy of the use of Marcaine in femoral nerve blocks and hematoma blocks for post operative pain relief for femoral shaft fractures in a pediatric population.

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Detailed Description

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Children with femur fractures can have severe pain after elastic nail fixation. The current national standard for post operative pain control would be intravenous narcotics. In addition to the use of intravenous narcotics, there are two alternative methods used during the surgery in order to potentially decrease the pain post-operatively. These methods are hematoma block or a femoral nerve block. Both are proven safe and effective in children, however little research has been done to look at the effectiveness of these various methods compared to one another.

Conditions

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Femoral Fractures Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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PCA only

this group will only get a pain control anesthesia pump to use for post-operative pain

Group Type NO_INTERVENTION

No interventions assigned to this group

PCA and femoral nerve block

this group will be receiving a femoral nerve block during surgery and have a PCA post-operatively

Group Type EXPERIMENTAL

Marcaine

Intervention Type DRUG

0.75 cc/kg of 1/4% Marcaine

PCA + hematoma block

patient will receive hematoma block during surgery

Group Type EXPERIMENTAL

Marcaine

Intervention Type DRUG

0.75 cc/kg of 1/4% Marcaine

Interventions

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Marcaine

0.75 cc/kg of 1/4% Marcaine

Intervention Type DRUG

Other Intervention Names

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bupivacaine

Eligibility Criteria

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Inclusion Criteria

* A child with a femoral shaft fracture requiring surgical treatment and the placement of intramedullary nails
* Weight of 30-100 Kg
* Child must be older than 6 years old

Exclusion Criteria

* Any child that had an open fracture
* A child that has a pain abnormality
* Any child with an allergy to local anesthetic
* Any child with a neurological injury
* Any child with the inability to report pain
* Any child that is unable to use a PCA post-operatively

Minimum Eligible Age

7 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No