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Local Anesthetic
Erector Spinae Plane Block for Scoliosis
N/A
Waitlist Available
Led By Jordan Ruby, MD
Research Sponsored by Hospital for Special Surgery, New York
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
Study Summary
This trial will help determine if the ultrasound-guided Erector Spinae Plane Block (ESPB) can help reduce patients' pain levels and need for opioid medication during and after pediatric spinal fusion surgery.
Who is the study for?
Adolescents aged 10-19 with adolescent idiopathic scoliosis undergoing spinal fusion surgery can join this trial. They must be under the care of participating surgeons and speak English. Excluded are those with neuromuscular scoliosis, chronic opioid therapy or pain conditions requiring certain medications, allergies to study drugs, or non-English speakers.Check my eligibility
What is being tested?
The trial is testing if an Erector Spinae Plane Block (ESPB), which involves injecting a mix of bupivacaine and dexamethasone into back muscles, reduces pain and opioid use after pediatric spinal fusion surgery for scoliosis compared to no ESPB.See study design
What are the potential side effects?
Possible side effects from the ESP block may include discomfort at injection site, potential nerve damage, allergic reactions to bupivacaine or dexamethasone, and less commonly infection or bleeding where the drug was injected.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of patients who receive bilateral, pre-incision ESPB
Secondary outcome measures
Attrition
Blinding Assessment
Incidence of intra- and postoperative complications attributed to ESPB
+7 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: ESPB with Bupivacaine and DexamethasoneActive Control1 Intervention
12 pediatric spinal fusion surgery patients will be randomized to receive intraoperative ultrasound-guided bilateral ESPB with 0.25% bupivacaine with 2mg preservative free dexamethasone with a maximum of 30 mL total per side, depending on the patient's weight.
Group II: No ESPBPlacebo Group1 Intervention
12 pediatric spinal fusion surgery patients will be randomized to not receive an intraoperative ultrasound-guided bilateral ESPB. These patients will still receive the standard anesthesia regimen during and after surgery.
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Who is running the clinical trial?
Hospital for Special Surgery, New YorkLead Sponsor
243 Previous Clinical Trials
59,340 Total Patients Enrolled
6 Trials studying Postoperative Pain
333 Patients Enrolled for Postoperative Pain
Jordan Ruby, MDPrincipal InvestigatorHospital for Special Surgery, New York
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have scoliosis related to a neuromuscular condition.You have been regularly taking strong pain medication for more than 4 weeks to treat scoliosis-related back pain.You have chronic pain and need to take gabapentin or pregabalin.You are between 10 and 19 years old.You are currently having surgery to fuse and stabilize multiple levels of your spine from the back.You are having surgery to fix a curved spine that starts during adolescence.You are not between 10 and 19 years old.
Research Study Groups:
This trial has the following groups:- Group 1: No ESPB
- Group 2: ESPB with Bupivacaine and Dexamethasone
Awards:
This trial has 0 awards, including: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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this trial recruiting elderly-exempt participants?
"This clinical trial has set the minimum age requirement for enrollment at 10 years old and caps it off with a maximum of 19."
Answered by AI
Are there vacancies available for participants in this trial?
"As noted on clinicaltrials.gov, this medical trial is not presently recruiting patients. The experiment was initially posted in February 2021 and last updated in September 2022. Despite the fact that enrollment has closed for this study, 664 other trials are still welcoming participants."
Answered by AI
Are my criteria consistent with the requirements for this clinical research?
"This medical trial, which plans to enrol 24 participants, requires that prospective patients be between the ages of 10 and 19. Additionally, they must exhibit postoperative pain in order to qualify for inclusion."
Answered by AI
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