Pain Control During ESWL Using Non-Opioid Analgesics (ESWL-PAIN)

April 5, 2026 updated by: Mehmet Öztürk, University of Gaziantep

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ibuprofen
Participants receive ibuprofen prior to ESWL for pain control.
Drug: Ibuprofen (Brufen®)
Ibuprofen administered prior to ESWL for pain control.
Experimental: Paracetamol
Participants receive paracetamol prior to ESWL for pain control.
Drug: Paracetamol (drug)
Paracetamol administered prior to ESWL for pain control.
Experimental: Tenoxicam
Participants receive tenoxicam prior to ESWL for pain control.
Drug: Placebo
Placebo administered prior to ESWL.
Placebo Comparator: Placebo
Participants receive placebo prior to ESWL.
Drug: Tenoxicam
Tenoxicam administered prior to ESWL for pain control.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During ESWL procedure (up to 20 minutes)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within 2-4 weeks after ESWL

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Gaziantep

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

March 30, 2026

First Submitted That Met QC Criteria

March 30, 2026

First Posted (Actual)

April 6, 2026

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 5, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GAUNIV-URO-ESWL-ANALG-26.03.61

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Individual participant data (IPD) sharing is currently undecided. Data may be shared upon reasonable request after publication, in accordance with institutional policies and ethical considerations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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