Postoperative Pain Control in AIS Using Liposomal Bupivacaine vs. 0.25% Bupivacaine With Epinephrine
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bupivacaine liposome injectable suspension, Bupivacaine Hydrochloride and Epinephrine Injection.
- Who it may be relevant to
- Registry conditions: Post Operative Pain, Spinal Fusion. Basic parameters: 10 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Postoperative Pain Control in AIS Using Liposomal Bupivacaine vs. 0.25% Bupivacaine
Overview
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.
Interventions
- Drug 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. - Drug 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).
Primary outcome measures
- Total amount of morphine equivalents per kilogram [Time frame: 72 hours postoperatively]
Secondary outcome measures (2)
- Numeric Rating Scale (NRS) pain scores [Time frame: 72 hours postoperatively]
- Pain, functional ability, and mental health scores [Time frame: 1-, 6-, 12-, and 24-months 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Boston Children's Hospital — Boston
Identifiers
NCT: NCT06471348 · IRB-P00048597