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Opiranserin Injections PCA Regimens for Postoperative Pain
Sponsor: Samsung Medical Center
Summary
The purpose of this phase 2 study is to evaluate the efficacy and safety of PCA regimen of opiranserin (VVZ-149) injections in patients undergoing laparoscopic colectomy.
Official title: A Phase 2, Randomized, Double-Blind, Parallel Group, Exploratory Study to Evaluate the Efficacy and Safety of PCA Regimen of VVZ-149 Injections for the Treatment of Post-Operative Pain
Key Details
Gender
All
Age Range
19 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
66
Start Date
2025-07-22
Completion Date
2026-01-09
Last Updated
2026-09-15
Healthy Volunteers
No
Conditions
Interventions
VVZ-149 Injections
VVZ-149 injections mixed with normal saline will be intravenously infused as a 180 mg loading dose over 30 minutes, starting from the initiation of surgical closure. After recovery from anesthesia, VVZ-149 injections will be administered via PCA (VVZ-149 10 mg in 2 mL, 10-min lock-out, basal infusion 6 mL/h)
VVZ-149 Injections
VVZ-149 injections mixed with normal saline will be intravenously infused as a 180 mg loading dose over 30 minutes, starting from the initiation of surgical closure. After recovery from anesthesia, VVZ-149 injections + fentanyl will be administered (VVZ-149 injections 10 mg + fentanyl 4 μg in 2 mL, 10-min lock-out, basal infusion 6 mL/h)
Fentanyl
VVZ-149 injections mixed with normal saline will be intravenously infused as a 180 mg loading dose over 30 minutes, starting from the initiation of surgical closure. After recovery from anesthesia, VVZ-149 injections + fentanyl will be administered (VVZ-149 injections 10 mg + fentanyl 4 μg in 2 mL, 10-min lock-out, basal infusion 6 mL/h)
Locations (1)
Samsung Medical Center
Seoul, South Korea