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Erector Spinae Plane Blocks for Adolescent Idiopathic Scoliosis

Study Purpose

Pediatric spinal fusion (PSF) surgery is a painful procedure that can treat adolescent idiopathic scoliosis (AIS). One technique that can potentially reduce patients' pain levels and need for opioid medication is the ultrasound-guided Erector Spinae Plane Block (ESPB). The ESP block is a technique that involves injecting an anesthetic medication into the muscles of the lower back on both sides of the spine. Previous studies have shown that ESPB application led to a reduction in opioid use, and there is one pediatric case report of ESPB use in two patients undergoing PSF. However, there is still lack of evidence that the ESPB technique is feasible and effective in the pediatric patient population. The present study is designed to be the first randomized controlled trial to evaluate the role of ESPB in pediatric spinal fusion surgery and the role of ESPB within an enhanced recovery pathway.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 10 Years - 19 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Age 10-19 years old.
  • - Patients undergoing multilevel posterior spinal instrumentation and fusion.
  • - Undergoing surgery for correction of adolescent idiopathic scoliosis.
  • - Patients under the care of participating surgeons.
  • - English Speaking.

Exclusion Criteria:

  • - Patients younger than 10 years old or older than 19 years old.
  • - Neuromuscular scoliosis.
  • - Patient under the care of non-participating surgeon performing the procedure.
  • - History of chronic opioid therapy (longer than 4 weeks) to treat back pain attributed to scoliosis tolerance, as defined by Centers for Disease Control (CDC) criteria (more than 60 oral morphine equivalents (OME) daily for over 2 weeks) - Chronic pain conditions necessitating neuromodulating medications (gabapentin, pregabalin) - Allergy, intolerance, or contraindication to any protocol component/study medication/technique.
  • - Patient or parent refusal.
- Non-english speaking

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04500613
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Hospital for Special Surgery, New York
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Jordan Ruby, MD
Principal Investigator Affiliation Hospital for Special Surgery, New York
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Enrolling by invitation
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Pain, Postoperative, Opioid Use, Recruitment
Arms & Interventions

Arms

Active Comparator: ESPB with Bupivacaine and Dexamethasone

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.

Placebo Comparator: No ESPB

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.

Interventions

Procedure: - Bilateral Erector Spinae Plane Block with bupivacaine and dexamethasone

Bupivacaine is administered typically to reduce sensation in an area. It acts as a nerve block for surgical procedures. Dexamethasone is a corticosteroid that reduces inflammation.

Other: - No bilateral Erector Spinae Plane Block (no bupivacaine and no dexamethasone)

Patients who are randomized to this group will not receive a bilateral erector spinae plane block

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Hospital for Special Surgery (HSS), New York, New York

Status

Address

Hospital for Special Surgery (HSS)

New York, New York, 10021

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