Ultrasound-Guided Block of the Lateral Femoral Cutaneous Nerve in Pediatric Patients
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 Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of Ultrasound-Guided Block of the Lateral Femoral Cutaneous Nerve in Pediatric Patients for Reconstructive Surgical Procedures|
- Visual Analog Pain Scale [ Time Frame: Q4 hours,while awake, for 48 hours ] [ Designated as safety issue: No ]We will assess a VAS of pain (0-10)--every 4 hours postoperatively while the patient is awake, for 48 hours post-op.
- Narcotic use [ Time Frame: 48 hours postoperative ] [ Designated as safety issue: No ]We will record narcotic requirements of the subjects over the 48 hours post operatively.
|Study Start Date:||April 2008|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01500655
|Contact: Erik S Shank, MDfirstname.lastname@example.org|
|Contact: Daniel N Driscoll, MDemail@example.com|
|United States, Massachusetts|
|Shriners Hospital for Children||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Erik S Shank, MD 617-724-3154 firstname.lastname@example.org|
|Principal Investigator:||Erik S Shank, MD||Partners Health Care|