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Completed

NCT Number: NCT04500613

Erector Spinae Plane Blocks for Adolescent Idiopathic Scoliosis

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.

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Opioid Use Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Recruitment Signs and Symptoms

Age range

10 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital for Special Surgery (HSS)

New York, 10021, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Primary outcomes

  1. Number of Patients Who Receive Bilateral, Pre-incision ESPB

    Time frame: through study completion, an average of 1 year

    number who receive the intervention and complete all assessments

Secondary outcomes

  1. Rate of Recruitment

    Time frame: through study completion, an average of 1 year

    Number enrolled and allocated to specific group

  2. Blinding Assessment

    Time frame: 24 hours after surgery

    Based on Bang's Blinding Index. Patients' ability to determine whether or not they received the ESPB. The success of patient blinding in each group will be quantified using the Bang Blinding Index which ranges from -1 to 1. Scores closest to 0 indicate a less likelihood that patients were able to guess which group they were randomized into. A score of 1 or -1 means that patients were able to guess which group they were in or guessed the wrong group, respectively. This value is obtained by asking patients which group they believe they were randomly assigned to.

  3. Number of Participants Unable to Receive ESPB Block.

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

    Number of participants who were randomized to receive the ESPB block, but were unable to receive the block. The no ESPB group were randomized not to get the ESPB block, leading to 0 instances of missed ESPB block.

  4. Attrition

    Time frame: through study completion, an average of 1 year

    Number of patients who enroll but do not receive the intervention and/or study assessments.

  5. Incidence of Intra- and Postoperative Complications Attributed to ESPB

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

    Interference with intraoperative neuromonitoring, infection, local anesthetic toxicity, bleeding/hematoma, extremity weakness

  6. Pain Scores at Rest and Movement

    Time frame: PACU (Post Anesthesia Care Unit, hour 0), hour 8, 12, and 24 hours after surgery, and at hospital discharge (an average of 4 days)

    Measured by Numeric Rating Scale (NRS) pain at rest and with movement (0 being no pain and 10 being as bad as you can imagine). NRS was collected for each participant, Mean and Standard Deviations are found below.

  7. Total Opioid Consumption

    Time frame: 0-24 hours after surgery (OME within 24 hrs)

    Measured in mean oral morphine equivalents (OME)

  8. Time to First Opioid Use

    Time frame: Up to 24 hours after surgery

    Time to pressing Intravenous Patient-Controlled Analgesia (IV PCA) and to requesting first oral opioid

  9. Opioid Related Side Effects

    Time frame: 24 hours after surgery

    Measured by 10 symptom Opioid Related Symptom Distress Scale (ORSDS). Frequency of each symptom within the cohort was assessed.

  10. Patient/Parent Satisfaction With Pain Management

    Time frame: At hospital discharge (an average of 4 days)

    Measured via Likert rating scale (0 being strongly dissatisfied and 10 being strongly satisfied)

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Official study title

Utilization of Erector Spinae Plane Blocks in a Multimodal Analgesic Pathway for Instrumentation and Fusion of Adolescent Idiopathic Scoliosis: A Feasibility Study

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 5, 2020
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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