BurnsNCT01500655
Ultrasound-Guided Block of the Lateral Femoral Cutaneous Nerve in Pediatric Patients
A study testing Regional nerve block and Catheter in people with Burns, run by Massachusetts General Hospital at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 2 to 21 years
- Conditions the study is for
- Burns
- What is being tested?
- Regional nerve block and Catheter
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- potential block/catheter site infected or burned.
- intolerance/allergy to local anesthetics
- BMI > 30
- American Society of Anesthesiologists (ASA) score > 2
Trial locations and contacts
1 site in 1 country.
United States1 site
Shriners Hospital for Children
Boston, Massachusetts, 02114
About this study
Official title: Evaluation of Ultrasound-Guided Block of the Lateral Femoral Cutaneous Nerve in Pediatric Patients for Reconstructive Surgical Procedures
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.
- Conditions
- Burns
- Being tested
- Regional nerve block, Catheter
- Keywords
- burn, skin graft donor site, analgesia for donor site
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regional nerve blockProcedure or surgery
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.
CatheterProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Catheter | Experimental | An ultrasound guided block of the LFCN is performed, followed by the placement of a catheter underneath the fascia iliaca. Receives: Procedure: Regional nerve block; Procedure: Catheter |
| Ultrasound guided LFCN block | Experimental | An ultrasound guided regional nerve block --using ropivacaine 0.2%-- will be performed around the lateral femoral cutaneous nerve (LFCN). Receives: Procedure: Regional nerve block |
| Control | No intervention | This group gets the current standard of care--the donor site is infiltrated with 0.25% bupivacaine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Q4 hours,while awake, for 48 hours
Secondary outcomes (1)
Narcotic use
We will record narcotic requirements of the subjects over the 48 hours post operatively.
Measured: 48 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2011 (estimated)
- Study startApr 2008
- Primary completionJul 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erik S. Shank, MD, Massachusetts General Hospital
- Investigators
- Erik S Shank, MD, Principal investigator, Partners Health Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01500655
- Sponsor's protocol ID
- 2008P001944
- Status last verified
- Dec 2016
- First submitted
- 23 Dec 2011
- Last updated
- 6 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Ultrasound-Guided Block of the Lateral Femoral Cutaneous Nerve in Pediatric Patients for Reconstructive Surgical Procedures
- ClinicalTrials.gov ID
- NCT01500655
- Acronym / sponsor ID
- 2008P001944
- Conditions
- Burns
- Keywords
- burn, skin graft donor site, analgesia for donor site
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Jul 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 28 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Catheter | Experimental | Procedure: Regional nerve block, Procedure: CatheterAn ultrasound guided block of the LFCN is performed, followed by the placement of a catheter underneath the fascia iliaca. |
| Ultrasound guided LFCN block | Experimental | Procedure: Regional nerve blockAn ultrasound guided regional nerve block --using ropivacaine 0.2%-- will be performed around the lateral femoral cutaneous nerve (LFCN). |
| Control | No intervention | –This group gets the current standard of care--the donor site is infiltrated with 0.25% bupivacaine. |
Who may qualify
- Ages
- 2 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- potential block/catheter site infected or burned.
- intolerance/allergy to local anesthetics
- BMI > 30
- American Society of Anesthesiologists (ASA) score > 2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regional nerve blocka 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 or surgery | Catheter, Ultrasound guided LFCN block |
| CatheterAfter 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. | Procedure or surgery | Catheter |
Primary outcome
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.
1 secondary outcome
Narcotic use
Time frame: 48 hours postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erik S Shank, MD principal investigator
Partners Health Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regional nerve block and Catheter in people with Burns, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Pain Scale (time frame: Q4 hours,while awake, for 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2016.