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