Erector Spinae Plane Block for Pediatric Idiopathic Scoliosis Surgery

Phase 4

Recruiting

• Conditions: Scoliosis Idiopathic
• Interventions: Drug: Sham block; Drug: ESPB

• Registration Number: NCT05938959
• Lead Sponsor: Poznan University of Medical Sciences

Brief Summary

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.

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 Timeline

• Study Start: 2023-05-01
• Study First Submitted: 2023-05-24
• Study First Submitted QC: 2023-07-06
• Study First Posted: 2023-07-11
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-11
• Last Update Posted: 2023-10-13
• Primary Completion: 2024-07-30
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham group	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
ESPB group	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)

Primary Outcome Measures

Name	Time	Method
Pain Numerical Rating Scale	48 hours after surgery	Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)

Secondary Outcome Measures

Name	Time	Method
neutrophil/lymphocyte ratio	12 hours and 24 hours after surgery	neutrophil/lymphocyte ratio
platelet/lymphocyte ratio	12 hours and 24 hours after surgery	platelet/lymphocyte ratio
Nausea or Vomiting	during first 24 hours after surgery	presence or absence
total opioid consumption	Day 7 after surgery	intravenous milligrams of morphine equivalents
Motor Evoked Potential amplitude	up to 24 weeks following the correction of scoliosis	Motor Evoked Potentials during surgery

Trial Locations

Locations (2)

Poznan University of Medical Sciences; 🇵🇱 Poznań, Poland

Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznań, Poland; 🇵🇱 Poznań, Wielkopolska, Poland