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

Study Overview
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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.

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.

Official Title
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Examining the Efficacy of Femoral Nerve Block in Children With a Femoral Shaft Fracture

Conditions
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Femoral Fractures, Pain, Postoperative

Intervention / Treatment
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* Drug: Marcaine


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: PCA only<br>this group will only get a pain control anesthesia pump to use for post-operative pain | |
| Experimental: PCA and femoral nerve block<br>this group will be receiving a femoral nerve block during surgery and have a PCA post-operatively | Drug: Marcaine<br>* 0.75 cc/kg of 1/4% Marcaine<br>* Other names: bupivacaine;|
| Experimental: PCA + hematoma block<br>patient will receive hematoma block during surgery | Drug: Marcaine<br>* 0.75 cc/kg of 1/4% Marcaine<br>* Other names: bupivacaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative Pain Scores | 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 Hurts a little bit Hurts a little more Hurts even more Hurts a whole lot Hurts worst | with in the first 24 hours | 
| Post-operative Narcotic Use | We will be looking at the amount of narcotics used after surgery to see if there is a reduction in narcotic use | within first 24 horus | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Femur Fracture Healing | we will following patients to look at fracture healing post-operatively | first year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Femoral Fractures, Pediatrics, Pain, Postoperative