Ultrasound-Guided Block of the Lateral Femoral Cutaneous Nerve in Pediatric Patients

NCT01500655 | Completed DMC

• 1 other identifier: 2008P001944
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether either a peripheral nerve block under ultrasound (u/s) guidance of the lateral femoral cutaneous nerve (LFCN), versus an u/s guided block of the nerve followed by continuous catheter infusion of local anesthetic, offers better post-operative analgesia in pediatric burn patients undergoing reconstructive surgery, than the current analgesic regimen of subcutaneous local anesthetic infiltration. Eligible subject, pediatric patients having reconstructive surgery for burns, having skin graft donor sites of the lateral thighs, will be randomized into three groups: control (having local infiltration of site), ultrasound guided nerve block, or ultrasound guided nerve block with catheter placement --fascia iliac. Post-operative comfort will be assessed over the next 48 hours.

Conditions

Burns

Keywords

burn; skin graft donor site; analgesia for donor site

Outcome Measures

Primary Outcomes (1)

• Visual Analog Pain Scale

  We will assess a VAS of pain (0-10)--every 4 hours postoperatively while the patient is awake, for 48 hours post-op.

  Q4 hours,while awake, for 48 hours

Secondary Outcomes (1)

• Narcotic use

  48 hours postoperative

Study Arms (3)

Catheter

EXPERIMENTAL

An ultrasound guided block of the LFCN is performed, followed by the placement of a catheter underneath the fascia iliaca.

Procedure: Regional nerve block; Procedure: Catheter

Ultrasound guided LFCN block

EXPERIMENTAL

An ultrasound guided regional nerve block --using ropivacaine 0.2%-- will be performed around the lateral femoral cutaneous nerve (LFCN).

Procedure: Regional nerve block

Control

NO INTERVENTION

This group gets the current standard of care--the donor site is infiltrated with 0.25% bupivacaine.

Interventions

Regional nerve block PROCEDURE

a block of the lateral femoral cutaneous nerve is performed under ultrasound guidance. For LFCN block, ropivacaine 0.2% will be used. Dose will be 20 ml, unless patient weighs less than 20 kg, in which case volume will be equal to patient's weight in kilograms.

Catheter; Ultrasound guided LFCN block

Catheter PROCEDURE

After an ultrasound guided nerve block is performed a catheter is placed under the fascia iliaca and an infusion of ropivacaine 0.2% running at 0.15 ml/kg/hour is administered for 48 hours.

Catheter

Eligibility Criteria

• Age: 2 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• going for reconstructive surgery requiring split thickness skin graft
• patient's donor site will be in distribution of lateral femoral cutaneous nerve
• age \>=2 and \<22
• patient emotionally/intellectually able to describe intensity of post-op pain using VAS or Wong- Baker faces scale.

You may not qualify if:

• potential block/catheter site infected or burned.
• intolerance/allergy to local anesthetics
• BMI \> 30
• American Society of Anesthesiologists (ASA) score \> 2

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Shriners Hospital for Children

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Burns

Interventions

Catheters

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Erik S Shank, MD

  Partners Health Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician: Pediatric Anesthesiologist

Study Record Dates

• First Submitted: December 23, 2011
• First Posted: December 28, 2011
• Study Start: April 1, 2008
• Primary Completion: July 1, 2013
• Study Completion: September 1, 2013
• Last Updated: December 6, 2016

Record last verified: 2016-12

Locations

US (1)