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RECRUITING
NCT06471348
NA

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

Sponsor: Boston Children's Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

10 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

128

Start Date

2025-08-15

Completion Date

2028-08-31

Last Updated

2025-10-22

Healthy Volunteers

No

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).

Locations (1)

Boston Children's Hospital

Boston, Massachusetts, United States