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Completed

NCT Number: NCT01500655

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.

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Key information

Conditions

Burns Wounds and Injuries

Age range

2 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shriners Hospital for Children

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  1. Visual Analog Pain Scale

    Time frame: 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 outcomes

  1. Narcotic use

    Time frame: 48 hours postoperative

    We will record narcotic requirements of the subjects over the 48 hours post operatively.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Dec 28, 2011
Registry last updated
Dec 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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