Postoperative Pain Control in AIS Using Liposomal Bupivacaine vs. 0.25% Bupivacaine
Boston Children's Hospital
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
- Age range
- 10–17 years
- Sex
- All
- Healthy volunteers
- No
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
- DrugBupivacaine liposome injectable suspension
EXPAREL is a milky white too off-white aqueous suspension available as single-dose vials. Each mL contains 13.3 mg of bupivacaine, which is contained in multivesicular liposomes.
- DrugBupivacaine Hydrochloride and Epinephrine Injection
Sensorcaine-MPF with Epinephrine 1:200,000 is a clear, colorless to slightly yellow solution available as single-dose vials. Each mL contains bupivacaine hydrochloride, 0.005 mg epinephrine, and 0.5 mg sodium metabisulfite (antioxidant), and 0.2 mg anhydrous citric acid (stabilizer).
Location
- Boston Children's HospitalBoston, Massachusetts