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

Burns Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01500655
• Other study ID #: 2008P001944
• Status: Completed
• Phase: N/A
• First received: December 23, 2011
• Last updated: December 5, 2016
• Start date: April 2008
• Est. completion date: September 2013

Study information

• Verified date: December 2016
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: September 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 21 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burns

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Shriners Hospital for Children	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Narcotic use	We will record narcotic requirements of the subjects over the 48 hours post operatively.	48 hours postoperative	No