Ultrasound-Guided Block of the Lateral Femoral Cutaneous Nerve in Pediatric Patients
This study is currently recruiting participants.
Verified January 2013 by Massachusetts General Hospital
Sponsor:
Massachusetts General Hospital
Information provided by (Responsible Party):
Erik S. Shank, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01500655
First received: December 23, 2011
Last updated: January 30, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Burns |
Procedure: Regional nerve block Procedure: Catheter |
| Study Type: | Interventional |
| 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 |
Resource links provided by NLM:
Further study details as provided by Massachusetts General Hospital:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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.
| Estimated Enrollment: | 30 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 2 Years to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01500655
Contacts
| Contact: Erik S Shank, MD | 617-724-3154 | eshank@partners.org |
| Contact: Daniel N Driscoll, MD | 617-726-3599 | dkdriscoll@partners.org |
Locations
| United States, Massachusetts | |
| Shriners Hospital for Children | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Erik S Shank, MD 617-724-3154 eshank@partners.org | |
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
| Principal Investigator: | Erik S Shank, MD | Partners Health Care |
More Information
No publications provided
| Responsible Party: | Erik S. Shank, MD, Staff Physician: Pediatric Anesthesiologist, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT01500655 History of Changes |
| Other Study ID Numbers: | 2008P001944 |
| Study First Received: | December 23, 2011 |
| Last Updated: | January 30, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Massachusetts General Hospital:
|
burn skin graft donor site analgesia for donor site |
ClinicalTrials.gov processed this record on May 23, 2013