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

Not Applicable

Completed

• Conditions: Burns
• Interventions: Procedure: Regional nerve block; Procedure: Catheter

• Registration Number: NCT01500655
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2011-12-23
• Study First Submitted QC: 2011-12-27
• Study First Posted: 2011-12-28
• Primary Completion: 2013-07
• Study Completion: 2013-09
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-05
• Last Update Posted: 2016-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Catheter	Regional nerve block	An ultrasound guided block of the LFCN is performed, followed by the placement of a catheter underneath the fascia iliaca.
Catheter	Catheter	An ultrasound guided block of the LFCN is performed, followed by the placement of a catheter underneath the fascia iliaca.
Ultrasound guided LFCN block	Regional nerve block	An ultrasound guided regional nerve block --using ropivacaine 0.2%-- will be performed around the lateral femoral cutaneous nerve (LFCN).

Primary Outcome Measures

Name	Time	Method
Visual Analog Pain Scale	Q4 hours,while awake, for 48 hours	We will assess a VAS of pain (0-10)--every 4 hours postoperatively while the patient is awake, for 48 hours post-op.

Secondary Outcome Measures

Name	Time	Method
Narcotic use	48 hours postoperative	We will record narcotic requirements of the subjects over the 48 hours post operatively.

Trial Locations

Locations (1)

Shriners Hospital for Children; 🇺🇸 Boston, Massachusetts, United States