Erector Spinae Block for Pain Management in Scoliosis Surgery
Erector Spinae Plane (ESP) Block for Pain Management in Juvenile Idiopathic Scoliosis Surgery: a Single-center, Randomized Controlled Trial
This study is testing if adding a special pain management technique called an Erector Spinae Block to regular anesthesia can help teenagers with scoliosis feel less pain and use fewer opioids after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 14 Years to 25 Years |
| Sex | All |
| Sponsor | Istituto Ortopedico Rizzoli Academic / other |
| Locations | 1 site (Bologna, BO) |
| Trial ID | NCT06196463 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare two methods of anesthetic management during spinal surgery for juvenile idiopathic scoliosis. One group of adolescent patients will receive an Erector Spinae (ESP) Block, an ultrasound-guided regional anesthesia technique, in addition to general anesthesia, while the other group will receive only general anesthesia. The study will evaluate pain levels and opioid consumption in the first 24 hours post-surgery to determine the effectiveness of the ESP Block in pain management. The trial is designed to provide insights into improving postoperative pain control in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 14 and older who are scheduled for elective spine surgery for idiopathic scoliosis and meet specific health criteria.
Not a fit: Patients who have previously undergone spinal procedures, are under 14 years old, or are on chronic opioid therapy 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: Previous studies have shown promising results with the use of regional anesthesia techniques like the ESP Block in various surgical settings, suggesting potential success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Elective indication for spine surgery for idiopathic scoliosis at the Spinal Surgery Department and Clinic 1 of the Rizzoli Orthopedic Institute. * ASA Status 1 - 3 * BMI\<32 * Expression of assent to informed consent Exclusion Criteria: * Patients who have previously undergone spinal procedures or surgery; * Age under 14 years * Patients on chronic opioid therapy (defined as the use of opioids continuously in the previous 3 months); * Neuro-muscular pathologies; * Allergy to drugs that are part of the study protocol; * Cognitive deficit.
Where this trial is running
Bologna, BO
- Istituto Ortopedico Rizzoli — Bologna, Bo, Italy (Recruiting)
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.