drugset / Trial / NCT06604598

The Effect of NSAID Steroid Therapy for PGE2 Level and Analgesia After Percutaneous Nephrolithotomy Surgery

NCT06604598

Phase 4 Completed 45 enrolled Universitas Jenderal Soedirman
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The goal of this clinical trial is to learn if combination of NSAID-steroid can decrease the PGE2 level and postoperative pain after percutaneous nephrolithotomy surgery. It will also learn about the side effects of combination of those drugs. The main questions it aims to answer are: Does combination of NSAID steroid can lower the PGE2 level and NRS score after percutaneous nephrolithotomy surgery? What side effect do participants have when taking combination of NSAID-steroid after percutaneous nephrolithotomy surgery? Researchers will compare Group IBU-PCT-DEX (ibuprofen -paracetamol-dexamethasone), Group IBU-PCT-placebo (ibuprofen-paracetamol-placebo), and Group PCT-placebo-placebo (paracetamol-placebo-placebo) to see the difference level of PGE2 and NRS score after percutaneous nephrolithotomy surgery. Participants will: Receive drug intravenously according to group allocation, every 8 hours Report the side effects when taking medication during trial

Timeline

Start
2024-10-08
Primary completion
2024-11-08
Completion
2024-11-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule 5 mg Intravenous
Subject Ibuprofen Small molecule 400 mg Intravenous
Background Acetaminophen Small molecule 1 g Intravenous

Indications