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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3
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)
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)
Bupivacaine, 15 mg/mL per epidural PLUS administration of 4 mL Placebo to each of three nerves for a total of 12 mL (intercostal)
Lotus Clinical Research
Pasadena, California, United States
Florida Hospital
Orlando, Florida, United States
Memorial Hermann - Memorial City Medical Center
Houston, Texas, United States
Houston NW Medical Center
Houston, Texas, United States
Amount of Rescue PCA Fentanyl Administered for Breakthrough Pain During the First 72 Hours.
The primary outcome metric was to be the amount of rescue epidural fentanyl administered for breakthrough pain during the first 72 hours postoperatively. Patient-controlled analgesia (PCA) fentanyl intake was to be summarized for each treatment group as time to first use of rescue PCA fentanyl, amount of PCA fentanyl administered over 72 hours, and total amount of PCA fentanyl administered through a number of time intervals. However, efficacy analyses were not performed because the study was terminated early after only three subjects were enrolled.
Time frame: 72 hours
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Fentanyl via PCA
Bupivacaine via epidural
Multicare Health System
Tacoma, Washington, United States