Clinical trial NCT05938959: Erector Spinae Plane Block for Pediatric Idiopathic Scoliosis Surgery
Official title: Erector Spinae Plane Block for Pediatric Idiopathic Scoliosis Surgery. A Prospective, Randomized, Double-blinded Clinical Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Scoliosis Idiopathic
Keywords: pain management
peripheral nerve block
erector spinae plane block
euromonitoring
Lead sponsor: Poznan University of Medical Sciences
Sponsor class: OTHER
First posted: 2023-07-11
Enrollment: 100
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain Numerical Rating Scale
timeFrame: 30 minutes after surgery
measure: Pain Numerical Rating Scale
timeFrame: 60 minutes after surgery
measure: Pain Numerical Rating Scale
timeFrame: 90 minutes after surgery
measure: Pain Numerical Rating Scale
timeFrame: 120 minutes after surgery
measure: Pain Numerical Rating Scale
timeFrame: 6 hours after surgery
measure: Pain Numerical Rating Scale
timeFrame: 12 hours hours after surgery
measure: Pain Numerical Rating Scale
timeFrame: 24 hours after surgery
measure: Pain Numerical Rating Scale
timeFrame: 48 hours after surgery
Secondary outcomes:
measure: neutrophil/lymphocyte ratio
timeFrame: 12 hours and 24 hours after surgery
measure: platelet/lymphocyte ratio
timeFrame: 12 hours and 24 hours after surgery
measure: Nausea or Vomiting
timeFrame: during first 24 hours after surgery
measure: total opioid consumption
timeFrame: Day 1 after surgery
measure: total opioid consumption
timeFrame: Day 2 after surgery
measure: total opioid consumption
timeFrame: Day 3 after surgery
measure: total opioid consumption
timeFrame: Day 4 after surgery
measure: total opioid consumption
timeFrame: Day 5 after surgery
measure: total opioid consumption
timeFrame: Day 6 after surgery
measure: total opioid consumption
timeFrame: Day 7 after surgery
measure: Motor Evoked Potential amplitude
timeFrame: up to seven days prior to the correction of scoliosis
measure: Motor Evoked Potential amplitude
timeFrame: up to 24 weeks following the correction of scoliosis
Other outcomes:
Locations:
city: Poznań
country: Poland
facility: Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznań, Poland
state: Wielkopolska
city: Poznań
country: Poland
facility: Poznan University of Medical Sciences
Study officials:
affiliation: Poznań University of Medical Sciences
name: Tomasz Kotwicki, Ph.D.
role: STUDY_DIRECTOR
References: