Erector spinae plane block to reduce post-operative pain after posterior spinal fusion in children
The Effect of Erector Spinae Plane Block (ESPB) on Pediatric Pain Management Following Posterior Spinal Fusion (PSF) Surgery
PHASE3 · University of California, San Francisco · NCT07561827
This will try giving an erector spinae plane block with ropivacaine to see if it reduces pain and the need for opioid pain medicine after posterior spinal fusion in children with adolescent idiopathic or neuromuscular scoliosis.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 10 Years to 18 Years |
| Sex | All |
| Sponsor | University of California, San Francisco (other) |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT07561827 on ClinicalTrials.gov |
What this trial studies
The study tests whether an erector spinae plane block (ESPB) using the local anesthetic ropivacaine reduces post-operative pain and opioid consumption in children undergoing posterior spinal fusion for adolescent idiopathic or neuromuscular scoliosis. The ESPB involves an injection of ropivacaine into the back muscles near the spine to block pain signals from the surgical site. Investigators will record post-operative pain scores and amounts of pain medication used during the hospital recovery period. The trial is conducted at the University of California, San Francisco and enrolls pediatric patients who meet the inclusion and exclusion criteria.
Who should consider this trial
Good fit: Children and adolescents with adolescent idiopathic scoliosis or neuromuscular scoliosis who are scheduled for posterior spinal fusion, are not taking pre-operative opioids, and have no allergy or contraindication to ropivacaine.
Not a fit: Patients with other types of scoliosis, those undergoing a different spinal procedure, those with contraindications to ESPB or ropivacaine, or those already on pre-operative opioids are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the ESPB could lower post-operative pain and opioid use and help children recover more comfortably after spinal fusion.
How similar studies have performed: Smaller case series and adult studies have shown reduced pain and opioid use with ESPB, but high-quality pediatric randomized data are still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of Adolescent Idiopathic Scoliosis (AIS) or neuromuscular scoliosis * Undergoing Posterior Spinal Fusion (PSF) Surgery Exclusion Criteria: * Patients with forms of scoliosis other than AIS or NM Scoliosis. * Patients undergoing a spinal deformity correction surgery other than Posterior Spinal Fusion Surgery * Allergy or other contraindication to erector spinae plane block (ESPB) with Ropivacaine patients who are taking pre-operative opioids
Where this trial is running
San Francisco, California
- University of California San Francisco — San Francisco, California, United States (RECRUITING)
Study contacts
- Principal investigator: Ishaan Swarup, MD — University of California, San Francisco
- Study coordinator: Tripta Rughwani
- Email: tripta.rughwani@ucsf.edu
- Phone: 415-353-4701
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: Adolescent Idiopathic Scoliosis, Neuromuscular Scoliosis, posterior spinal fusion, pain management