Erector Spinae Plane Blocks for Adolescent Idiopathic Scoliosis

NCT04500613 | Completed Results

• 1 other identifier: 2019-2131
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain, Postoperative; Opioid Use; Recruitment

Outcome Measures

Primary Outcomes (1)

• Number of Patients Who Receive Bilateral, Pre-incision ESPB

  number who receive the intervention and complete all assessments

  through study completion, an average of 1 year

Secondary Outcomes (10)

• Rate of Recruitment

  through study completion, an average of 1 year

• Blinding Assessment

  24 hours after surgery

• Number of Participants Unable to Receive ESPB Block.

  Holding area, Post-Anesthesia Care Unit (PACU) (hour 0), hour 8, 12, and 24 hours after surgery

• Attrition

  through study completion, an average of 1 year

• Incidence of Intra- and Postoperative Complications Attributed to ESPB

  During surgery, PACU (hour 0), hour 8, 12, and 24 hours after surgery

Study Arms (2)

ESPB with Bupivacaine and Dexamethasone

ACTIVE COMPARATOR

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.

Procedure: Bilateral Erector Spinae Plane Block with bupivacaine and dexamethasone

No ESPB

PLACEBO COMPARATOR

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.

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

Interventions

Bilateral Erector Spinae Plane Block with bupivacaine and dexamethasone PROCEDURE

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.

ESPB with Bupivacaine and Dexamethasone

No bilateral Erector Spinae Plane Block (no bupivacaine and no dexamethasone) OTHER

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

No ESPB

Eligibility Criteria

• Age: 10 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery (HSS)

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine; Dexamethasone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Marko Popovic
• Organization: Hospital for Special Surgery

popovicm@hss.edu

646-797-8948

Study Officials

• Jordan Ruby, MD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2020
• First Posted: August 5, 2020
• Study Start: February 22, 2021
• Primary Completion: November 28, 2022
• Study Completion: December 2, 2022
• Last Updated: December 27, 2024
• Results First Posted: December 2, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• Access Criteria: Data will be shared with investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose.

Locations

US (1)