drugset / Trial / NCT07512297

Pain Control During ESWL Using Non-Opioid Analgesics

NCT07512297

Phase 4 Not yet recruiting 160 enrolled University of Gaziantep
RandomizedParallel-groupTriple-blindTreatment

Summary

This prospective randomized controlled trial aims to compare the analgesic efficacy of three non-opioid analgesics (ibuprofen, paracetamol, and tenoxicam) during extracorporeal shock wave lithotripsy (ESWL). All patients undergoing ESWL will be randomly assigned into four groups including a placebo group. Pain intensity will be assessed using the Visual Analog Scale (VAS) at the 5th, 10th, 15th, and 20th minutes during the procedure. In addition to comparing analgesic efficacy, the study will evaluate patient-related and stone-related factors affecting pain perception, including body mass index, subcutaneous fat thickness, and stone density measured by Hounsfield Units. The study also aims to assess the relationship between analgesic efficacy, energy levels applied during ESWL, and treatment outcomes such as stone-free rates. The findings may contribute to optimizing individualized pain management strategies and improving treatment efficiency in ESWL procedures.

Timeline

Start
2026-04-01
Primary completion
2026-12-01
Completion
2027-03-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Acetaminophen Small molecule
Subject Ibuprofen Small molecule
Comparator Tenoxicam Other / unclassified