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Pain Control During ESWL Using Non-Opioid Analgesics

NCT07512297 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2026-04-09

No results posted yet for this study

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.

Conditions

  • Urolithiasis
  • Kidney Stones
  • Ureteral Stones

Interventions

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.

Sponsors & Collaborators

  • University of Gaziantep

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07512297 on ClinicalTrials.gov