NCT00485433

Dose-ranging Study for Postoperative Analgesia in Subjects Undergoing Primary Unilateral Inguinal Hernia Repair

A Phase 2 Multicenter, Randomized, Double-blind, Parallel-group, Active-control, Dose-ranging Study to Evaluate the Safety and Efficacy of a Single Administration of SKY0402 for Prolonged Postoperative Analgesia in Subjects Undergoing Primary Unilateral Inguinal Hernia Repair.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Pacira Pharmaceuticals, Inc · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate three dose levels of SKY0402 compared with 105 mg of bupivacaine HCl.

Detailed description

Effective postoperative pain control is a critical element in patient recovery, as the majority of patients may experience significant pain, particularly in the first few days following surgery. Appropriate postoperative pain management contributes to improved healing, faster patient mobilization, shortened hospital stays, and reduced healthcare costs.

Conditions

• Postoperative Pain

Interventions

Type	Name	Description
DRUG	Bupivacaine HCl	Bupivacaine HCl given during hernia repair
DRUG	SKY0402	SKY0402 given during hernia repair

Timeline

• Start date: 2007-06-01
• Primary completion: 2007-12-01
• Completion: 2008-08-01
• First posted: 2007-06-13
• Last updated: 2021-03-02
• Results posted: 2013-08-06

Locations

7 sites across 1 country: United States