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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
J. Eric Gordon, Washington University
ClinicalTrials.gov Identifier:
NCT01294098
First received: February 9, 2011
Last updated: June 4, 2014
Last verified: June 2014
  Purpose

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 (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    we will following patients to look at fracture healing post-operatively


Estimated Enrollment: 180
Study Start Date: February 2011
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (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.

  Eligibility

Ages Eligible for Study:   7 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01294098

Locations
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
Investigators
Principal Investigator: J. Eric Gordon, MD Washington University Early Recognition Center
  More Information

No publications provided

Responsible Party: J. Eric Gordon, Director of Clinical Services, Pediatric Orthopedic Surgery, Washington University
ClinicalTrials.gov Identifier: NCT01294098     History of Changes
Other Study ID Numbers: 10-0331
Study First Received: February 9, 2011
Last Updated: June 4, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Fractures, Bone
Pain, Postoperative
Femoral Fractures
Wounds and Injuries
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Leg Injuries

ClinicalTrials.gov processed this record on September 22, 2014