Efficacy Study of Femoral Nerve Block in Children With a Femur Fracture

Examining the Efficacy of Femoral Nerve Block in Children With a Femoral Shaft Fracture

The purpose of this study is to examine the efficacy of the use of Marcaine in femoral nerve blocks and hematoma blocks for post operative pain relief for femoral shaft fractures in a pediatric population.

Study Overview

• Status: Terminated
• Conditions: Pain, Postoperative; Femoral Fractures
• Intervention / Treatment: Drug: Marcaine

Detailed Description

Children with femur fractures can have severe pain after elastic nail fixation. The current national standard for post operative pain control would be intravenous narcotics. In addition to the use of intravenous narcotics, there are two alternative methods used during the surgery in order to potentially decrease the pain post-operatively. These methods are hematoma block or a femoral nerve block. Both are proven safe and effective in children, however little research has been done to look at the effectiveness of these various methods compared to one another.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University
    • Saint Louis, Missouri, United States, 63110
      • St. Louis Childrens Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• A child with a femoral shaft fracture requiring surgical treatment and the placement of intramedullary nails
• Weight of 30-100 Kg
• Child must be older than 6 years old

Exclusion Criteria:

• Any child that had an open fracture
• A child that has a pain abnormality
• Any child with an allergy to local anesthetic
• Any child with a neurological injury
• Any child with the inability to report pain
• Any child that is unable to use a PCA post-operatively

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: PCA only; this group will only get a pain control anesthesia pump to use for post-operative pain
Experimental: PCA and femoral nerve block; this group will be receiving a femoral nerve block during surgery and have a PCA post-operatively	Drug: Marcaine; 0.75 cc/kg of 1/4% Marcaine; Other Names: bupivacaine
Experimental: PCA + hematoma block; patient will receive hematoma block during surgery	Drug: Marcaine; 0.75 cc/kg of 1/4% Marcaine; Other Names: bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative Pain Scores	We will be looking at post-operative pain scores to see if those in the intervention group have lower pains scores. Wong Baker FACES pain scale:The faces correspond to numeric values from 0-5. This scale can be documented with the numeric value. The pain scale goes from 0-5 with 0 being no pain and 5 being the worst pain. 0: No Hurt; Hurts a little bit; Hurts a little more; Hurts even more; Hurts a whole lot; Hurts worst	with in the first 24 hours
Post-operative Narcotic Use	We will be looking at the amount of narcotics used after surgery to see if there is a reduction in narcotic use	within first 24 horus

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Femur Fracture Healing	we will following patients to look at fracture healing post-operatively	first year

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: J. Eric Gordon, MD, Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2011
• Primary Completion (Actual): October 8, 2013
• Study Completion (Actual): October 8, 2014

Study Registration Dates

• First Submitted: February 9, 2011
• First Submitted That Met QC Criteria: February 9, 2011
• First Posted (Estimate): February 11, 2011

Study Record Updates

• Last Update Posted (Actual): March 30, 2018
• Last Update Submitted That Met QC Criteria: March 28, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Pediatrics; Pain, Postoperative; Femoral Fractures
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Wounds and Injuries; Leg Injuries; Pain, Postoperative; Femoral Fractures; Fractures, Bone; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 10-0331