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Regional Anesthesia
ESP Block Anesthesia for Microtia Surgery
N/A
Waitlist Available
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ages 2-17
Pediatric patients undergoing rib cartilage resection surgeries
Must not have
Patients who are clinically unstable or require urgent/emergent intervention
Timeline
Screening 3 weeks
Treatment Varies
Follow Up duration of study (typically 4-5 days)
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new way to numb the chest and stomach during surgery. They want to see if it decreases pain and the amount of pain medication needed afterwards.
Who is the study for?
This trial is for children and teenagers aged 2-17 who are having surgery to correct ear deformities using rib cartilage. They must be able to agree to the study themselves if they're over 7, or have their parents' consent.
What is being tested?
The trial is testing a new pain-blocking technique called Erector Spinae Plane Block in kids and teens undergoing ear surgeries with rib cartilage grafts. It aims to see if this method reduces pain and the need for strong painkillers after surgery.
What are the potential side effects?
While specific side effects aren't listed, regional anesthesia techniques like ESP blocks may cause discomfort at the injection site, itching, or numbness beyond the targeted area.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 2 and 17 years old.
Select...
I am a child scheduled for rib cartilage surgery.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I need immediate medical attention for my condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ duration of study (typically 4-5 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration of study (typically 4-5 days)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Evaluating Pain Scores Using 0-10 Numeric Pain Scale (0=No Pain, 10=Worst Pain)
Evaluating Pain Scores Using Faces, Legs, Activity, Cry, and Consolability (FLACC) Scale
Evaluating Pain Scores Using Wong-Baker FACES Pain Rating Scale
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment ArmExperimental Treatment1 Intervention
ESP Block
Group II: Control ArmActive Control1 Intervention
Standard of Care
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Erector Spinae Plane Block
2020
Completed Phase 2
~1060
Find a Location
Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,469 Previous Clinical Trials
17,501,697 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need immediate medical attention for my condition.I am between 2 and 17 years old.I am a child scheduled for rib cartilage surgery.I can give my consent and have my parents' consent if I'm over 7 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Arm
- Group 2: Control Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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