NCT06471348

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: Boston Children's Hospital · Academic / Other
• Sex: All
• Age: 10 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Post Operative Pain
• Spinal Fusion

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2025-08-15
• Primary completion: 2027-08-15
• Completion: 2028-08-31
• First posted: 2024-06-24
• Last updated: 2025-10-22

Locations

1 site across 1 country: United States