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

The Washington University

Status: Terminated

Conditions: Femoral Fractures; Pain, Postoperative

Treatments: Drug: Marcaine

Study type: Interventional

Funder types: Other

Identifiers

NCT01294098

10-0331

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 7 to 14 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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2 participants in 3 patient groups

PCA only

No Intervention group

Description:

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

PCA and femoral nerve block

Experimental group

Description:

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

Treatment:

Drug: Marcaine

PCA + hematoma block

Experimental group

Description:

patient will receive hematoma block during surgery

Treatment:

Drug: Marcaine