Femoral Nerve Block for Femur Fracture Repair in Pediatrics

January 2, 2018 updated by: Nicole Elsey, Nationwide Children's Hospital

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • Naropin
Drug: Epinephrine
No Intervention: Standard Anesthetic Management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 mins after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 1/2 hr.
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.
From PACU discharge until first opioid dose on the ward, assessed up to 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nationwide Children's Hospital

Investigators

  • Principal Investigator: Nicole Elsey, MD, Nationwide Children's

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

December 29, 2012

First Submitted That Met QC Criteria

December 29, 2012

First Posted (Estimate)

January 3, 2013

Study Record Updates

Last Update Posted (Actual)

January 25, 2018

Last Update Submitted That Met QC Criteria

January 2, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB16-00338

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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