Pain management for adolescents undergoing scoliosis surgery
Erector Spinae Plane Block for Pediatric Idiopathic Scoliosis Surgery. A Prospective, Randomized, Double-blinded Clinical Trial.
PHASE4 · Poznan University of Medical Sciences · NCT05938959
This study is testing whether a special pain management technique can help teenagers feel less pain and use fewer opioids after surgery for scoliosis.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 10 Years to 18 Years |
| Sex | All |
| Sponsor | Poznan University of Medical Sciences (other) |
| Locations | 2 sites (Poznań, Wielkopolska and 1 other locations) |
| Trial ID | NCT05938959 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of bilateral erector spinae plane (ESP) blocks in managing postoperative pain in adolescents undergoing surgery for idiopathic scoliosis. It compares pain scores and opioid consumption between a treatment group receiving ESP blocks and a control group receiving a sham block. The blocks are administered under ultrasound guidance at two vertebral levels, and the study aims to determine their impact on pain control and rehabilitation. Primary outcomes include postoperative pain scores and opioid requirements until hospital discharge.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 10-18 who are scheduled for surgical correction of idiopathic scoliosis.
Not a fit: Patients with a history of chronic pain, morbid obesity, previous surgeries, or infections at the block application site may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce postoperative pain and opioid use in adolescents undergoing scoliosis surgery.
How similar studies have performed: Other studies have shown promising results with similar nerve block techniques for pain management, suggesting potential efficacy in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Poznań, Wielkopolska and 1 other locations
- Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznań, Poland — Poznań, Wielkopolska, Poland (RECRUITING)
- Poznan University of Medical Sciences — Poznań, Poland (RECRUITING)
Study contacts
- Study coordinator: Magorzata Domagalska, Ph.D.
- Email: m.domagalska@icloud.com
- Phone: 0048608762068
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Scoliosis Idiopathic, pain management, peripheral nerve block, erector spinae plane block, euromonitoring