NCT00807209

Dose Finding Posterolateral Thoracotomy Study

A Phase 2 Open-Label, Parallel Group, Randomized, Dose-Finding Study to Assess the Efficacy and Safety of Intercostal SKY0402 in Subjects Undergoing Posterolateral Thoracotomy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Pacira Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To review safety and effectiveness of two doses compared to current standard of care.

Detailed description

Evaluate the efficacy of intercostal nerve block using SKY0402 compared to epidural bupivacaine HCl in subjects undergoing posterolateral thoracotomy. The primary outcome metric for this will be the amount of rescue PCA fentanyl administered for breakthrough pain during the first 72 hours.

Conditions

• Postoperative Pain

Interventions

Type	Name	Description
DRUG	Low Dose SKY0402	Bupivacaine, 15 mg/mL via epidural PLUS single total administration of 75mg SKY0402 (25 mg to each of three segments) in 4 mL volume each for a total of 12 mL via nerve block (intercostal)
DRUG	High Dose SKY0402	Bupivacaine, 15 mg/mL via epidural PLUS single total administration of 150 mg (50 mg to each of three segments) in 4 mL volume each for a total of 12 mL via nerve block (intercostal)
DRUG	Placebo	Bupivacaine, 15 mg/mL per epidural PLUS administration of 4 mL Placebo to each of three nerves for a total of 12 mL (intercostal)
DRUG	Fentanyl via PCA	Fentanyl via PCA
DRUG	Bupivacaine via epidural	Bupivacaine via epidural

Timeline

• Start date: 2008-12-01
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2008-12-11
• Last updated: 2012-05-15
• Results posted: 2012-05-15

Locations

5 sites across 1 country: United States