Postoperative Pain Clinical Trial
Official title:
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
To review safety and effectiveness of two doses compared to current standard of care.
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. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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