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Femoral Nerve Block for Femur Fracture Repair in Pediatrics

This study has been terminated.
(Interim analysis showed no significant difference between study arms.)
ClinicalTrials.gov Identifier:
First Posted: January 3, 2013
Last Update Posted: November 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nicole Elsey, Nationwide Children's Hospital
The purpose of this study is to prospectively compare post-operative pain relief in pediatric patients undergoing traumatic femur fracture repair who have received either a femoral nerve block with a lateral femoral cutaneous nerve block or a standard anesthetic for analgesia.

Condition Intervention Phase
Traumatic Femur Fracture Drug: Ropivicaine Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Double-blinded, Randomized Comparison of Ultrasound-guided Femoral Nerve Block With Lateral Femoral Cutaneous Nerve Block Versus Standard Anesthetic Management for Traumatic Femur Fracture Repair in the Pediatric Population

Resource links provided by NLM:

Further study details as provided by Nicole Elsey, Nationwide Children's Hospital:

Primary Outcome Measures:
  • Pain [ Time Frame: 24 hours post-op ]
    Pain scores will be assessed.

Secondary Outcome Measures:
  • Narcotic usage [ Time Frame: 24 hours post-op ]
  • Extubation [ Time Frame: 1 hour post-op ]
    Time from completion of the surgery to endotracheal extubation

Enrollment: 19
Study Start Date: May 2013
Study Completion Date: October 2016
Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Femoral Nerve Block
Ropivicaine 0.2% with epinephrine 1:200,000 will be used for patients between 10kg and up to 25kg in weight; ropivicaine 0.5% with epinephrine 1:200,000 will be used for patients greater than or equal to 25kg
Drug: Ropivicaine
Other Name: Naropin
No Intervention: Standard Anesthetic Management


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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • ASA physical status I or II
  • Weight greater than or equal to 10kg
  • Presenting for repair of traumatic femur fracture

Exclusion Criteria:

  • ASA physical status > II
  • Co-morbid diseases (cardiac, pulmonary, neurological disease)
  • Patients having concomitant procedures
  • Abnormal neurovascular examination in the injured leg
  • Presence of vascular compromise in the affected lower extremity
  • Mechanism of sustained injury via crush injury
  • Use of therapeutic dose anticoagulants or presence of a bleeding disorder
  Contacts and Locations
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): NCT01759407

United States, Ohio
Nationwide Children's
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Nationwide Children's Hospital
Principal Investigator: Nicole Elsey, MD Nationwide Children's
  More Information

Responsible Party: Nicole Elsey, Clinical Assistant Professor, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01759407     History of Changes
Other Study ID Numbers: IRB16-00338
First Submitted: December 29, 2012
First Posted: January 3, 2013
Last Update Posted: November 14, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Fractures, Bone
Femoral Fractures
Wounds and Injuries
Leg Injuries
Central Nervous System Depressants
Physiological Effects of Drugs