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Femoral Nerve Block for Femur Fracture Repair in Pediatrics

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ClinicalTrials.gov Identifier: NCT01759407
Recruitment Status : Terminated (Interim analysis showed no significant difference between study arms.)
First Posted : January 3, 2013
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Traumatic Femur Fracture Drug: Ropivicaine Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
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
Study Start Date : May 2013
Primary Completion Date : October 2016
Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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


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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

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


Locations
United States, Ohio
Nationwide Children's
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Nationwide Children's Hospital
Investigators
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 Posted: January 3, 2013    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: March 2017

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