Back to results

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

Primary Purpose

Femoral Fractures, Pain, Postoperative

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Marcaine

About this trial

This is an interventional treatment trial for Femoral Fractures focused on measuring Femoral Fractures, Pediatrics, Pain, Postoperative

Eligibility Criteria

7 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

St. Louis Childrens Hospital
Washington University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Arm Label

PCA only

PCA and femoral nerve block

PCA + hematoma block

Arm Description

this group will only get a pain control anesthesia pump to use for post-operative pain

this group will be receiving a femoral nerve block during surgery and have a PCA post-operatively

patient will receive hematoma block during surgery

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Femur Fracture Healing

we will following patients to look at fracture healing post-operatively

Full Information

NCT ID

NCT01294098

First Posted

February 9, 2011

Last Updated

March 28, 2018

Sponsor

Washington University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT01294098

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Terminated

Why Stopped

Patients were not willing to be randomized and therefore recruitment could not continue.

Study Start Date

February 2011 (Actual)

Primary Completion Date

October 8, 2013 (Actual)

Study Completion Date

October 8, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Washington University School of Medicine

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Femoral Fractures, Pain, Postoperative

Keywords

Femoral Fractures, Pediatrics, Pain, Postoperative

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PCA only

Arm Type

No Intervention

Arm Description

this group will only get a pain control anesthesia pump to use for post-operative pain

Arm Title

PCA and femoral nerve block

Arm Type

Experimental

Arm Description

this group will be receiving a femoral nerve block during surgery and have a PCA post-operatively

Arm Title

PCA + hematoma block

Arm Type

Experimental

Arm Description

patient will receive hematoma block during surgery

Intervention Type

Drug

Intervention Name(s)

Marcaine

Other Intervention Name(s)

bupivacaine

Intervention Description

0.75 cc/kg of 1/4% Marcaine

Primary Outcome Measure Information:

Title

Post-operative Pain Scores

Description

Time Frame

with in the first 24 hours

Title

Post-operative Narcotic Use

Description

We will be looking at the amount of narcotics used after surgery to see if there is a reduction in narcotic use

Time Frame

within first 24 horus

Secondary Outcome Measure Information:

Title

Femur Fracture Healing

Description

we will following patients to look at fracture healing post-operatively

Time Frame

first year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

7 Years

Maximum Age & Unit of Time

14 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

J. Eric Gordon, MD

Organizational Affiliation

Washington University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

St. Louis Childrens Hospital

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Washington University

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs