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

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ClinicalTrials.gov Identifier: NCT01294098
Recruitment Status : Terminated (Patients were not willing to be randomized and therefore recruitment could not continue.)
First Posted : February 11, 2011
Results First Posted : March 30, 2018
Last Update Posted : March 30, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Femoral Fractures Pain, Postoperative Drug: Marcaine Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Examining the Efficacy of Femoral Nerve Block in Children With a Femoral Shaft Fracture
Actual Study Start Date : February 2011
Actual Primary Completion Date : October 8, 2013
Actual Study Completion Date : October 8, 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.

    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

  2. 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 :
  1. Femur Fracture Healing [ Time Frame: first year ]
    we will following patients to look at fracture healing post-operatively



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Ages Eligible for Study:   7 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01294098


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

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01294098     History of Changes
Other Study ID Numbers: 10-0331
First Posted: February 11, 2011    Key Record Dates
Results First Posted: March 30, 2018
Last Update Posted: March 30, 2018
Last Verified: March 2018

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
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Leg Injuries
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents