NCT04585867

Liposomal Bupivacaine vs Bupivacaine for Pain Control After Sternotomy

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Researchers hope to learn whether giving the longer-acting local anesthetic liposomal bupivacaine prior to closing the sternum is more effective in managing pain following sternotomy, than in patients who received standard bupivacaine before sternal closure. Researchers will measure this based on how much IV pain medication is used, rates on confusion, and time to remove the breathing tube.

Conditions

• Pain Management
• Sternotomy

Interventions

Type	Name	Description
DRUG	Exparel	The injections will be performed under direct guidance by the cardiac surgeon at bilateral sternal-costal interspaces 1.5 cm lateral the sternal boarder at levels 2-6 in divided doses (2 ml/injection) just before the closure of the sternum near the end of the surgical procedure. The final 20 ml will be injected into the skin incision after closure
DRUG	Bupivacaine	The injections will be performed under direct guidance by the cardiac surgeon at bilateral sternal-costal interspaces 1.5 cm lateral the sternal boarder at levels 2-6 in divided doses (2 ml/injection) just before the closure of the sternum near the end of the surgical procedure. The final 20 ml will be injected into the skin incision after closure

Timeline

• Start date: 2017-10-11
• Primary completion: 2023-10-10
• Completion: 2023-10-10
• First posted: 2020-10-14
• Last updated: 2020-10-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study