Conditions: Postoperative Pain
Keywords: Pain postoperative thoracotomy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 3
Healthy volunteers: no

Brief 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.

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: Low Dose SKY0402 intervention 2: High Dose SKY0402 intervention 3: Placebo intervention 4: Fentanyl via PCA intervention 5: Bupivacaine via epidural
Intervention descriptions: intervention 1: 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) intervention 2: 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) intervention 3: Bupivacaine, 15 mg/mL per epidural PLUS administration of 4 mL Placebo to each of three nerves for a total of 12 mL (intercostal) intervention 4: Fentanyl via PCA intervention 5: Bupivacaine via epidural

Protocol document: