NCT06471348NARecruiting

Postoperative Pain Control in AIS Using Liposomal Bupivacaine vs. 0.25% Bupivacaine With Epinephrine

Boston Children's Hospital

Start Date

8/15/2025

Completion Date

8/31/2028

Summary

A randomized controlled trial (RCT) investigating whether the local anesthetic injection of liposomal bupivacaine during posterior spinal fusion (PSF) for AIS is more effective in reducing acute postoperative opioid consumption compared to an equal volume injection of 0.25% bupivacaine with epinephrine for patients aged 10 to 17, with 128 patients randomly assigned to one of two arms: liposomal bupivacaine or 0.25% bupivacaine with epinephrine.

Eligibility Criteria

Age Range: 10 years to 17 years

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

Interventions

DRUG

Bupivacaine liposome injectable suspension

DRUG

Bupivacaine Hydrochloride and Epinephrine Injection

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Conditions

Post Operative PainSpinal Fusion

Locations

Boston Children's Hospital

Boston, Massachusetts 02115

United States