Erector Spinae Plane Block for Pediatric Idiopathic Scoliosis Surgery

Scoliosis Idiopathic Clinical Trial

— ESPB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05938959
• Other study ID #: 3/2023
• Status: Recruiting
• Phase: Phase 4
• Start date: May 1, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: October 2023
• Source: Poznan University of Medical Sciences
• Contact: Magorzata Domagalska, Ph.D.
• Phone: 0048608762068
• Email: m.domagalska[@]icloud.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 1, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Scoliosis
• Scoliosis Idiopathic

Intervention

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
• 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)

Locations

Country	Name	City	State
Poland	Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznan, Poland	Poznan	Wielkopolska
Poland	Poznan University of Medical Sciences	Poznan

Sponsors (1)

Lead Sponsor	Collaborator
Poznan University of Medical Sciences

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Numerical Rating Scale	Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)	30 minutes after surgery
Primary	Pain Numerical Rating Scale	Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)	60 minutes after surgery
Primary	Pain Numerical Rating Scale	Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)	90 minutes after surgery
Primary	Pain Numerical Rating Scale	Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)	120 minutes after surgery
Primary	Pain Numerical Rating Scale	Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)	6 hours after surgery
Primary	Pain Numerical Rating Scale	Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)	12 hours hours after surgery
Primary	Pain Numerical Rating Scale	Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)	24 hours after surgery
Primary	Pain Numerical Rating Scale	Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)	48 hours after surgery
Secondary	neutrophil/lymphocyte ratio	neutrophil/lymphocyte ratio	12 hours and 24 hours after surgery
Secondary	platelet/lymphocyte ratio	platelet/lymphocyte ratio	12 hours and 24 hours after surgery
Secondary	Nausea or Vomiting	presence or absence	during first 24 hours after surgery
Secondary	total opioid consumption	intravenous milligrams of morphine equivalents	Day 1 after surgery
Secondary	total opioid consumption	intravenous milligrams of morphine equivalents	Day 2 after surgery
Secondary	total opioid consumption	intravenous milligrams of morphine equivalents	Day 3 after surgery
Secondary	total opioid consumption	intravenous milligrams of morphine equivalents	Day 4 after surgery
Secondary	total opioid consumption	intravenous milligrams of morphine equivalents	Day 5 after surgery
Secondary	total opioid consumption	intravenous milligrams of morphine equivalents	Day 6 after surgery
Secondary	total opioid consumption	intravenous milligrams of morphine equivalents	Day 7 after surgery
Secondary	Motor Evoked Potential amplitude	Motor Evoked Potentials durring surgery	up to seven days prior to the correction of scoliosis
Secondary	Motor Evoked Potential amplitude	Motor Evoked Potentials during surgery	up to 24 weeks following the correction of scoliosis