We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Femoral Nerve Block for Femur Fracture Repair in Pediatrics

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.
ClinicalTrials.gov Identifier: NCT01759407
Recruitment Status : Terminated (Interim analysis showed no significant difference between study arms.)
First Posted : January 3, 2013
Results First Posted : January 25, 2018
Last Update Posted : January 25, 2018
Sponsor:
Information provided by (Responsible Party):
Nicole Elsey, Nationwide Children's Hospital

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 Drug: Epinephrine Phase 2

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

Drug Information available for: Epinephrine
U.S. FDA Resources

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
Drug: Epinephrine
No Intervention: Standard Anesthetic Management



Primary Outcome Measures :
  1. Post-anesthesia Care Unit (PACU) Pain Scores [ Time Frame: 30 mins after surgery ]
    Hannallah et al developed the Objective Pain Scale (OPS) to monitor pain in children after surgery. Parameters: (1) systolic blood pressure, (2) crying, (3) movement, (4) agitation (confused, excited), (5) complains of pain (may not be possible in younger children). Interpretation: minimum score: 0; maximum score: 10; maximum score if too young to complain of pain: 8; the higher the score, the greater the degree of pain.


Secondary Outcome Measures :
  1. Intraoperative End-tidal Isoflurane % [ Time Frame: 1 1/2 hr. ]
    Median end-tidal isoflurane concentration per participant during the average 1 1/2 hr. surgery.

  2. Time to First Opioid Dose [ Time Frame: From PACU discharge until first opioid dose on the ward, assessed up to 24 hours ]
    Median time between PACU discharge and first opioid dose on the ward.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Inclusion Criteria:

  • American Society of Anesthesiologists (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

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

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
Results First Posted: January 25, 2018
Last Update Posted: January 25, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Fractures, Bone
Femoral Fractures
Wounds and Injuries
Leg Injuries
Anesthetics
Epinephrine
Racepinephrine
Epinephryl borate
Central Nervous System Depressants
Physiological Effects of Drugs
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents