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

Poznan University of Medical Sciences (PUMS)

Status and phase: Enrolling; Phase 4

Conditions: Scoliosis Idiopathic

Treatments: Drug: Sham block; Drug: ESPB

Study type: Interventional

Funder types: Other

Identifiers

NCT05938959

3/2023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 10 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Sham group

Active Comparator group

Description:

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

Treatment:

Drug: Sham block

ESPB group

Active Comparator group

Description:

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)

Treatment:

Drug: ESPB