RecruitingNot ApplicableNCT06471348

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

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

Sponsor

Boston Children's Hospital

Enrollment

128 participants

Start Date

Aug 15, 2025

Study Type

INTERVENTIONAL

Conditions

Post Operative Pain Spinal Fusion

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

Min Age: 10 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Bupivacaine Hydrochloride and Epinephrine Injection and a drug called Bupivacaine liposome injectable suspension for people with post operative pain and spinal fusion. The study is currently recruiting participants at 1 location. People eligible for this study include aged 10 Years to 17 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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).