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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.)
Information provided by (Responsible Party):
Nicole Elsey, Nationwide Children's Hospital Identifier:
First received: December 29, 2012
Last updated: March 1, 2017
Last verified: March 2017
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


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
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Please refer to this study by its identifier: 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 Identifier: NCT01759407     History of Changes
Other Study ID Numbers: IRB16-00338
Study First Received: December 29, 2012
Last Updated: March 1, 2017

Additional relevant MeSH terms:
Fractures, Bone
Femoral Fractures
Wounds and Injuries
Leg Injuries
Central Nervous System Depressants
Physiological Effects of Drugs processed this record on September 21, 2017