NCT04102267

Extended Delivery of Bupivacaine Study in Herniorrhaphy

A Randomized, Phase 4 Study of the Efficacy, Safety, and Pharmacokinetics of Bupivacaine Administered as Liposomal Bupivacaine or Continuous Infusion Via Elastomeric Pump Following Unilateral Open Inguinal Herniorrhaphy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Heron Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 4, randomized, open-label study of the efficacy, safety, and pharmacokinetics of bupivacaine administered as liposomal bupivacaine or continuous infusion via elastomeric pump following unilateral open inguinal herniorrhaphy.

Conditions

• Analgesia

Interventions

Type	Name	Description
DRUG	Bupivacaine liposome injectable suspension	Liposomal bupivacaine 266 mg via injection
DRUG	Bupivacaine HCl without epinephrine via continuous infusion	Bupivacaine HCl 300 mg via continuous infusion

Timeline

• Start date: 2018-07-02
• Primary completion: 2018-09-03
• Completion: 2018-10-26
• First posted: 2019-09-25
• Last updated: 2019-09-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study