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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosed with Idiopathic scoliosis
Undergoing single-stage posterior spinal instrumentation and fusion
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through hospital stay, an average of 5 days
Awards & highlights
Study Summary
This trial aimed to compare the effects of the ESPB with those of the local infiltration analgesia (LIA) on the postoperative pain, inflammatory response, and stress response in patients undergoing spinal fusion for idiopathic scoliosis.
Who is the study for?
This trial is for children with idiopathic scoliosis who are undergoing a single-stage spinal fusion surgery. They should be generally healthy (ASA I-III) and within the normal weight range for their age. It's not suitable for those with developmental issues, severe organ dysfunction, pre-existing pain conditions, psychiatric diagnoses like anxiety or depression, allergies to lidocaine, seizure history, or if they need intensive care after surgery.Check my eligibility
What is being tested?
The study tests the effectiveness of Erector Spinae Plane Blockade (ESPB), which involves injecting local anesthetic near the spine muscles to manage pain post-scoliosis surgery. The goal is to see if ESPB can reduce reliance on opioids and better control inflammation-related acute pain without causing muscle weakness.See study design
What are the potential side effects?
While specific side effects of ESPB in this context may not be well-documented yet due to its novelty, potential risks include discomfort at injection site, infection risk from needle insertion, possible allergic reactions to anesthetics used like lidocaine and rare nerve damage.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with idiopathic scoliosis.
Select...
I am having a one-time back surgery to fuse and stabilize my spine.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through hospital stay, an average of 5 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through hospital stay, an average of 5 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Inpatient Postoperative Mobility
Length of Stay (LOS)
Maximum lidocaine plasma concentration [Cmax]
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Erector Spinae Plane Blockade TreatmentExperimental Treatment1 Intervention
Patients will receive an erector spinae plane blockade prior to their surgery as per standard regional anesthesia technique.
Group II: Erector Spinae Plane Blockade Control - Standard of CareActive Control1 Intervention
Patients will receive the standard of care for pediatric scoliosis surgery including multi-modal opioid pain management. If the patient declines to consent to enrollment into the randomized study, patients may still participate by allowing prospective data and samples collection/analysis with respect to perioperative choice.
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Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,406 Previous Clinical Trials
17,343,095 Total Patients Enrolled
2 Trials studying Scoliosis
53 Patients Enrolled for Scoliosis
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have scoliosis due to a birth defect or muscle condition.My surgery is not planned in stages.I regularly take pain medication for ongoing pain issues.I have porphyria.I have a history of seizures.I have a known heart, kidney, or liver condition.You are allergic to lidocaine.I need to be admitted to the Pediatric Intensive Care Unit.I need special pain management after surgery.I have a diagnosed psychiatric condition like anxiety or depression.My weight is either below the 5th percentile or above the 85th percentile for my age.I have been diagnosed with idiopathic scoliosis.You have a developmental delay or disorder.I am having a one-time back surgery to fuse and stabilize my spine.I have undergone a minimally invasive chest surgery.My treatment involves a two-stage procedure.
Research Study Groups:
This trial has the following groups:- Group 1: Erector Spinae Plane Blockade Control - Standard of Care
- Group 2: Erector Spinae Plane Blockade Treatment
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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