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

NCT01294098 | Terminated Results DMC

• 1 other identifier: 10-0331
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 2

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.

Conditions

Femoral Fractures; Pain, Postoperative

Keywords

Femoral Fractures; Pediatrics; Pain, Postoperative

Outcome Measures

Primary Outcomes (2)

• 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 1. Hurts a little bit 2. Hurts a little more 3. Hurts even more 4. Hurts a whole lot 5. 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 Outcomes (1)

• Femur Fracture Healing

  first year

Study Arms (3)

PCA only

NO INTERVENTION

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

PCA and femoral nerve block

EXPERIMENTAL

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

Drug: Marcaine

PCA + hematoma block

EXPERIMENTAL

patient will receive hematoma block during surgery

Drug: Marcaine

Interventions

Marcaine DRUG

0.75 cc/kg of 1/4% Marcaine

Also known as: bupivacaine

PCA + hematoma block; PCA and femoral nerve block

Eligibility Criteria

• Age: 7 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (2)

St. Louis Childrens Hospital

St Louis, Missouri, 63110, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Femoral Fractures; Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Lauren Westlund
• Organization: Washington University School of Medicine

davislauren@wustl.edu

314-454-5345

Study Officials

• J. Eric Gordon, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2011
• First Posted: February 11, 2011
• Study Start: February 1, 2011
• Primary Completion: October 8, 2013
• Study Completion: October 8, 2014
• Last Updated: March 30, 2018
• Results First Posted: March 30, 2018

Record last verified: 2018-03

Locations

US (2)