Dose Finding Posterolateral Thoracotomy Study

PHASE2TerminatedINTERVENTIONAL
Enrollment

3

Participants

Timeline

Start Date

December 31, 2008

Primary Completion Date

February 28, 2009

Study Completion Date

February 28, 2009

Conditions
Postoperative Pain
Interventions
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

Trial Locations (5)

32801

Florida Hospital, Orlando

77024

Memorial Hermann - Memorial City Medical Center, Houston

77053

Houston NW Medical Center, Houston

91105

Lotus Clinical Research, Pasadena

98405

Multicare Health System, Tacoma

Sponsors
All Listed Sponsors
lead

Pacira Pharmaceuticals, Inc

INDUSTRY

NCT00807209 - Dose Finding Posterolateral Thoracotomy Study | Biotech Hunter | Biotech Hunter