Liposomal bupivacaine versus standard bupivacaine with epinephrine for pain after adolescent spinal fusion
Official title: Postoperative Pain Control in AIS Using Liposomal Bupivacaine vs. 0.25% Bupivacaine
Run by Boston Children's Hospital · NCT06471348 · Data updated 2026-11-12
This trial tests whether injecting liposomal bupivacaine instead of 0.25% bupivacaine with epinephrine during posterior spinal fusion reduces opioid use after surgery in adolescents aged 10 to 17 with idiopathic scoliosis.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 10 Years to 17 Years |
| Sex | All |
| Enrollment | 128 (estimated) |
| Sponsor | Boston Children's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | August 15, 2025 |
| Main results expected | August 15, 2027 |
| Study ends | August 31, 2028 |
| Registry record updated | October 22, 2025 |
| Trial ID | NCT06471348 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients aged 10–17 with adolescent idiopathic scoliosis scheduled for posterior spinal fusion who are not chronic opioid users and can communicate in English.
✕Probably not a fit
Patients with neuromuscular, syndromic, or congenital scoliosis, those with chronic preoperative opioid use, or those allergic to local anesthetics are unlikely to benefit or are excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized controlled trial enrolling 128 patients aged 10–17 undergoing posterior spinal fusion for adolescent idiopathic scoliosis at Boston Children's Hospital. Participants are randomly assigned to receive either liposomal bupivacaine or an equal volume of 0.25% bupivacaine with epinephrine injected locally during the operation. The main outcome is acute postoperative opioid consumption, with additional monitoring of pain scores and postoperative recovery. The trial compares the two local anesthetic approaches to see if the longer-acting liposomal formulation reduces opioid needs and related side effects.
Why it matters
Potential benefit: If successful, this approach could reduce postoperative opioid use and improve pain control after spinal fusion in adolescents.
How similar studies have gone: Liposomal bupivacaine has shown mixed results in other surgical settings and high-quality evidence specifically for adolescent posterior spinal fusion is limited, making this application relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * ≥10 years old and ≤17 years old at assessment * Diagnosis of Adolescent Idiopathic Scoliosis * Planned surgical treatment of progressive spinal deformity with posterior spinal fusion Exclusion Criteria: * Diagnosis of neuromuscular, syndromic, or congenital scoliosis * History of known allergy to local anesthesia * Chronic pre-operative opioid consumptions * Any other analgesic treatment for chronic pain before surgery * Psychiatric or neurological disorders * Cannot fluently read or speak English
Where it's running
-
Boston Children's Hospital
Boston, Massachusetts, United States Recruiting
Study contacts
- Principal investigator: Craig Birch, MD — Boston Children's Hospital
- Study coordinator: Sara Olenich, MS
- Email: sara.olenich@childrens.harvard.edu
- Phone: (617) 355-6000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.