Erector Spinae Plane Block for Pediatric Idiopathic Scoliosis Surgery (ESPB)

Erector Spinae Plane Block for Pediatric Idiopathic Scoliosis Surgery. A Prospective, Randomized, Double-blinded Clinical Trial.

The study aims to assess the effect of the interfacial plane blocks on the pain level, the course of postoperative rehabilitation, and its anti-inflammatory analgesic effect.

Study Overview

• Status: Recruiting
• Conditions: Scoliosis Idiopathic
• Intervention / Treatment: Drug: Sham block; Drug: ESPB

Detailed Description

This study evaluates the analgesic efficacy in adolescents of bilevel, bilateral erector spinae plane (ESP) blocks after posterior spinal fusion surgery by assessing postoperative pain scores and opiate requirements as the primary outcome measures. We aim to investigate how ESP blocks, performed under ultrasound guidance at the two vertebral levels, contribute to postoperative pain control. This will be determined by measuring numerical rating pain scores repeatedly following surgery and opiate consumption until the patient is discharged from the hospital. These primary outcome measures will be compared between a treatment group of participants receiving ESP blocks and a control group receiving a sham block. Our primary hypothesis is that ESP blocks significantly reduce postoperative pain and opiate requirements.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Magorzata Domagalska, Ph.D.; Phone Number: 0048608762068; Email: m.domagalska@icloud.com

Study Locations

• Poland
  • Poznań, Poland
    • Recruiting
    • Poznan University of Medical Sciences
    • Contact: Grzegorz Kowalski, PhD; Email: gkowalski@ump.edu.pl
  • Wielkopolska
    • Poznań, Wielkopolska, Poland, 61-545
      • Recruiting
      • Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznań, Poland
      • Contact: Tomasz Kotwicki, Profesor; Phone Number: +48618310157; Email: kckod@ump.edu.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• age 10-18 years old
• pediatric patients who will undergo the surgical correction of idiopathic scoliosis

Exclusion Criteria:

• a history of chronic pain (use of gabapentin/pregabalin for > 3 months or opioid use > 1 repeated opioid prescription in the last three months)
• morbid obesity (BMI > 99th percentile)
• previous surgery
• back abnormalities
• infection at block application area
• coagulopathy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sham group; Bilateral ESPB under ultrasound guidance bi-level Th3-6 and Th9-L1(adjusted to the incision line): 0.3-0.5ml/kg 0,9% Normal Saline	Drug: Sham block; Bilateral ESPB under ultrasound guidance bi-level Th3-6 and Th9-L1(adjusted to the incision line): 0.3-0.5ml/kg 0,9% normal saline; Other Names: 0,9% normal saline
Active Comparator: ESPB group; Bilateral ESPB under ultrasound guidance bi-level Th3-6 and Th9-L1(adjusted to the incision line): 0.3-0.5ml/kg 0.2% Ropivacaine (max 2.5mg/kg)	Drug: ESPB; Bilateral ESPB under ultrasound guidance bi-level Th3-6 and Th9-L1(adjusted to the incision line): 0.3-0.5ml/kg 0.2% Ropivacaine (max 2.5mg/kg); Other Names: 0,2% ropivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Numerical Rating Scale	Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)	30 minutes after surgery
Pain Numerical Rating Scale	Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)	60 minutes after surgery
Pain Numerical Rating Scale	Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)	90 minutes after surgery
Pain Numerical Rating Scale	Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)	120 minutes after surgery
Pain Numerical Rating Scale	Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)	6 hours after surgery
Pain Numerical Rating Scale	Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)	12 hours hours after surgery
Pain Numerical Rating Scale	Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)	24 hours after surgery
Pain Numerical Rating Scale	Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)	48 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
neutrophil/lymphocyte ratio	neutrophil/lymphocyte ratio	12 hours and 24 hours after surgery
platelet/lymphocyte ratio	platelet/lymphocyte ratio	12 hours and 24 hours after surgery
Nausea or Vomiting	presence or absence	during first 24 hours after surgery
total opioid consumption	intravenous milligrams of morphine equivalents	Day 1 after surgery
total opioid consumption	intravenous milligrams of morphine equivalents	Day 2 after surgery
total opioid consumption	intravenous milligrams of morphine equivalents	Day 3 after surgery
total opioid consumption	intravenous milligrams of morphine equivalents	Day 4 after surgery
total opioid consumption	intravenous milligrams of morphine equivalents	Day 5 after surgery
total opioid consumption	intravenous milligrams of morphine equivalents	Day 6 after surgery
total opioid consumption	intravenous milligrams of morphine equivalents	Day 7 after surgery
Motor Evoked Potential amplitude	Motor Evoked Potentials durring surgery	up to seven days prior to the correction of scoliosis
Motor Evoked Potential amplitude	Motor Evoked Potentials during surgery	up to 24 weeks following the correction of scoliosis

Collaborators and Investigators

• Sponsor: Poznan University of Medical Sciences
• Investigators: Study Director: Tomasz Kotwicki, Ph.D., Poznan University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): July 30, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: May 24, 2023
• First Submitted That Met QC Criteria: July 6, 2023
• First Posted (Actual): July 11, 2023

Study Record Updates

• Last Update Posted (Actual): October 13, 2023
• Last Update Submitted That Met QC Criteria: October 11, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: pain management; erector spinae plane block; peripheral nerve block; euromonitoring
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: 3/2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No