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Clinical trial

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

ID
Name
IRB-P00048597
Description
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.
Trial arms
Trial start
2024-06-15
Estimated PCD
2026-08-31
Trial end
2028-08-31
Status
Not yet recruiting
Treatment
Bupivacaine 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.
Arms:
Local infiltration with liposomal bupivacaine
Other names:
EXPAREL
Bupivacaine 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).
Arms:
Local infiltration with 0.25% bupivacaine with epinephrine
Other names:
Sensorcaine-MPF with Epinephrine 1:200,000
Size
128
Primary endpoint
Total amount of morphine equivalents per kilogram
72 hours postoperatively
Eligibility 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 128, 'type': 'ESTIMATED'}}
Updated at
2024-06-24

1 organization

2 products

2 indications

Organization
Boston Children's Hospital
Product
Bupivacaine liposome
Indication
Postoperative Pain
Indication
Spinal Fusion
Product
Bupivacaine Hydrochloride and Epinephrine