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NCT Number: NCT07512297

Pain Control During ESWL Using Non-Opioid Analgesics

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.

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Key information

Conditions

Urolithiasis Agnosia Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Calculi Kidney Diseases Kidney Stones Male Urogenital Diseases Nephrolithiasis Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Ureteral Stones Urinary Calculi Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Gaziantep University Faculty of Medicine Hospital

Gaziantep, Turkey, Turkey (Türkiye)

Location contact

Mehmet Öztürk

CONTACT

[email protected]

+905393328554

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients (≥18 years) undergoing ESWL for urinary stone disease
  • Patients with kidney or ureteral stones indicated for ESWL
  • Ability to provide informed consent

Exclusion criteria

  • Known hypersensitivity or contraindication to ibuprofen, paracetamol, or tenoxicam
  • Chronic pain conditions or regular use of analgesics
  • Pregnancy or breastfeeding
  • Severe renal or hepatic impairment
  • Patients unable to complete pain assessment using VAS

Treatment and study plan

Ibuprofen (Brufen®)

Drug

Ibuprofen administered prior to ESWL for pain control.

Paracetamol (drug)

Drug

Paracetamol administered prior to ESWL for pain control.

Tenoxicam

Drug

Tenoxicam administered prior to ESWL for pain control.

Placebo

Drug

Placebo administered prior to ESWL.

Primary outcomes

  1. Pain Intensity During Extracorporeal Shock Wave Lithotripsy (ESWL) Measured by Visual Analog Scale (VAS)

    Time frame: During ESWL procedure (up to 20 minutes)

    Pain intensity will be assessed using the Visual Analog Scale (VAS), with scores ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Pain scores will be recorded at the 5th, 10th, 15th, and 20th minutes during the ESWL procedure. Higher scores indicate greater pain intensity and therefore a worse outcome. VAS scores will be compared between treatment groups.

Secondary outcomes

  1. Stone-Free Rate After Extracorporeal Shock Wave Lithotripsy (ESWL)

    Time frame: Within 2-4 weeks after ESWL

    Stone-free status will be defined as the absence of residual stone fragments on imaging performed 2 to 4 weeks after ESWL. The proportion of participants who are stone-free will be compared between treatment groups.

Study contacts

Contact information is provided by the study sponsor or research team.

Mehmet Öztürk

CONTACT

[email protected]

+905393328554

Sponsors and collaborators

Lead sponsor

University of Gaziantep

Other

Registry information

Official study title

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

Acronym: ESWL-PAIN

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Apr 6, 2026
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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