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

Not Applicable

Terminated

• Conditions: Pain, Postoperative; Femoral Fractures
• Interventions: Drug: Marcaine

• Registration Number: NCT01294098
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-09
• Study First Submitted QC: 2011-02-09
• Study First Posted: 2011-02-11
• Primary Completion: 2013-10-08
• Study Completion: 2014-10-08
• Results First Submitted: 2018-02-26
• Status Verified: 2018-03
• Results First Submitted QC: 2018-03-28
• Last Update Submitted: 2018-03-28
• Results First Posted: 2018-03-30
• Last Update Posted: 2018-03-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PCA and femoral nerve block	Marcaine	this group will be receiving a femoral nerve block during surgery and have a PCA post-operatively
PCA + hematoma block	Marcaine	patient will receive hematoma block during surgery

Primary Outcome Measures

Name	Time	Method
Post-operative Pain Scores	with in the first 24 hours	We will be looking at post-operative pain scores to see if those in the intervention group have lower pains scores.; Wong Baker FACES pain scale:The faces correspond to numeric values from 0-5. This scale can be documented with the numeric value. The pain scale goes from 0-5 with 0 being no pain and 5 being the worst pain.; 0: No Hurt; 1. Hurts a little bit; 2. Hurts a little more; 3. Hurts even more; 4. Hurts a whole lot; 5. Hurts worst
Post-operative Narcotic Use	within first 24 horus	We will be looking at the amount of narcotics used after surgery to see if there is a reduction in narcotic use

Secondary Outcome Measures

Name	Time	Method
Femur Fracture Healing	first year	we will following patients to look at fracture healing post-operatively

Trial Locations

Locations (2)

St. Louis Childrens Hospital; 🇺🇸 Saint Louis, Missouri, United States

Washington University; 🇺🇸 Saint Louis, Missouri, United States