Femoral Nerve Block for Femur Fracture Repair in Pediatrics

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
David P. Martin, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT01759407
First received: December 29, 2012
Last updated: May 23, 2014
Last verified: May 2014
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Nationwide Children's Hospital:

Primary Outcome Measures:
  • Pain [ Time Frame: 24 hours post-op ] [ Designated as safety issue: No ]
    Pain scores will be assessed.


Secondary Outcome Measures:
  • Narcotic usage [ Time Frame: 24 hours post-op ] [ Designated as safety issue: No ]
  • Extubation [ Time Frame: 1 hour post-op ] [ Designated as safety issue: No ]
    Time from completion of the surgery to endotracheal extubation


Estimated Enrollment: 40
Study Start Date: May 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (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

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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: NCT01759407

Locations
United States, Ohio
Nationwide Children's
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Nationwide Children's Hospital
Investigators
Principal Investigator: David P Martin, MD Nationwide Children's
  More Information

No publications provided

Responsible Party: David P. Martin, Clinical Assistant Professor, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01759407     History of Changes
Other Study ID Numbers: IRB12-00820
Study First Received: December 29, 2012
Last Updated: May 23, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Fractures, Bone
Femoral Fractures
Wounds and Injuries
Leg Injuries

ClinicalTrials.gov processed this record on September 18, 2014