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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01294098
• Other study ID #: 10-0331
• Status: Terminated
• Phase: N/A
• First received: February 9, 2011
• Last updated: March 28, 2018
• Start date: February 2011
• Est. completion date: October 8, 2014

Study information

• Verified date: March 2018
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: October 8, 2014
• Est. primary completion date: October 8, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Femoral Fractures
• Fractures, Bone
• Pain, Postoperative

Intervention

Drug:
• Marcaine
0.75 cc/kg of 1/4% Marcaine

Locations

Country	Name	City	State
United States	St. Louis Childrens Hospital	Saint Louis	Missouri
United States	Washington University	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Femur Fracture Healing	we will following patients to look at fracture healing post-operatively	first year