NCT07512297

Pain Control During ESWL Using Non-Opioid Analgesics

Comparative Evaluation of Non-Opioid Analgesics for Pain Control During Extracorporeal Shock Wave Lithotripsy: A Prospective Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: University of Gaziantep · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Extracorporeal shock wave lithotripsy (ESWL) is a widely used non-invasive treatment modality for urinary stone disease. Despite its minimally invasive nature, ESWL can cause significant pain due to the transmission of shock waves through skin, soft tissues, and renal structures. Inadequate pain control may lead to patient movement, reduced tolerance, and suboptimal targeting of the stone, ultimately affecting treatment success. This prospective randomized controlled study is designed to compare the analgesic efficacy of three commonly used non-opioid analgesics-ibuprofen, paracetamol, and tenoxicam-against placebo during ESWL. All patients will be included and randomly assigned into four equal groups using a computer-generated randomization method. Pain intensity will be evaluated using the Visual Analog Scale (VAS) at predefined time points (5th, 10th, 15th, and 20th minutes) during the ESWL procedure. The primary objective is to determine differences in pain control among the analgesic groups. Secondary objectives include evaluating the association between pain intensity and procedural parameters such as energy levels applied during ESWL, as well as patient-related and stone-related factors. These include body mass index (BMI), subcutaneous fat thickness, and stone density measured in Hounsfield Units (HU). In addition, treatment success will be assessed by stone-free rates, and the relationship between effective analgesia and the ability to apply higher energy levels will be analyzed. The study hypothesizes that improved analgesia may enhance patient tolerance, allow the application of higher energy levels, and consequently improve stone fragmentation and treatment outcomes. The results of this study may provide clinically relevant insights for optimizing analgesic protocols and individualizing patient management during ESWL procedures.

Conditions

• Urolithiasis
• Kidney Stones
• Ureteral Stones

Interventions

Type	Name	Description
DRUG	Ibuprofen (Brufen®)	Ibuprofen administered prior to ESWL for pain control.
DRUG	Paracetamol (drug)	Paracetamol administered prior to ESWL for pain control.
DRUG	Tenoxicam	Tenoxicam administered prior to ESWL for pain control.
DRUG	Placebo	Placebo administered prior to ESWL.

Timeline

• Start date: 2026-04-01
• Primary completion: 2026-12-01
• Completion: 2027-03-01
• First posted: 2026-04-06
• Last updated: 2026-04-09

Locations

1 site across 1 country: Turkey (Türkiye)