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

Evaluation of Ultrasound-Guided Block of the Lateral Femoral Cutaneous Nerve in Pediatric Patients for Reconstructive Surgical Procedures

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.

Study Overview

• Status: Completed
• Conditions: Burns
• Intervention / Treatment: Procedure: Regional nerve block; Procedure: Catheter

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Shriners Hospital for Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Catheter; An ultrasound guided block of the LFCN is performed, followed by the placement of a catheter underneath the fascia iliaca.	Procedure: Regional nerve block; 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.; Procedure: Catheter; 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.
Experimental: Ultrasound guided LFCN block; An ultrasound guided regional nerve block --using ropivacaine 0.2%-- will be performed around the lateral femoral cutaneous nerve (LFCN).	Procedure: Regional nerve block; 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.
No Intervention: Control; This group gets the current standard of care--the donor site is infiltrated with 0.25% bupivacaine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Narcotic use	We will record narcotic requirements of the subjects over the 48 hours post operatively.	48 hours postoperative

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Erik S Shank, MD, Partners Health Care

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: December 23, 2011
• First Submitted That Met QC Criteria: December 27, 2011
• First Posted (Estimate): December 28, 2011

Study Record Updates

• Last Update Posted (Estimate): December 6, 2016
• Last Update Submitted That Met QC Criteria: December 5, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: burn; skin graft donor site; analgesia for donor site
• Other Study ID Numbers: 2008P001944