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

This study is enrolling participants by invitation only.
Information provided by (Responsible Party):
J. Eric Gordon, Washington University School of Medicine Identifier:
First received: February 9, 2011
Last updated: June 10, 2015
Last verified: June 2015
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.

Condition Intervention
Femoral Fractures
Pain, Postoperative
Drug: Marcaine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Examining the Efficacy of Femoral Nerve Block in Children With a Femoral Shaft Fracture

Resource links provided by NLM:

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • post-operative pain scores [ Time Frame: 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.

  • post-operative narcotic use [ Time Frame: 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:
  • femur fracture healing [ Time Frame: first year ]
    we will following patients to look at fracture healing post-operatively

Estimated Enrollment: 180
Study Start Date: February 2011
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: PCA only
this group will only get a pain control anesthesia pump to use for post-operative pain
Experimental: PCA and femoral nerve block
this group will be receiving a femoral nerve block during surgery and have a PCA post-operatively
Drug: Marcaine
0.75 cc/kg of 1/4% Marcaine
Other Name: bupivacaine
Experimental: PCA + hematoma block
patient will receive hematoma block during surgery
Drug: Marcaine
0.75 cc/kg of 1/4% Marcaine
Other Name: bupivacaine

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.

Ages Eligible for Study:   7 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01294098

United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63110
St. Louis Childrens Hospital
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Principal Investigator: J. Eric Gordon, MD Washington University School of Medicine
  More Information

Responsible Party: J. Eric Gordon, Director of Clinical Services, Pediatric Orthopedic Surgery, Washington University School of Medicine Identifier: NCT01294098     History of Changes
Other Study ID Numbers: 10-0331
Study First Received: February 9, 2011
Last Updated: June 10, 2015

Keywords provided by Washington University School of Medicine:
Femoral Fractures
Pain, Postoperative

Additional relevant MeSH terms:
Fractures, Bone
Pain, Postoperative
Femoral Fractures
Wounds and Injuries
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Leg Injuries
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents processed this record on April 28, 2017