Pain Control During ESWL Using Non-Opioid Analgesics

ConditionsUrolithiasis Kidney Stones Ureteral Stones

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18-75

SponsorUniversity of Gaziantep

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients (≥18 years) undergoing ESWL for urinary stone disease

Patients with kidney or ureteral stones indicated for ESWL

Ability to provide informed consent

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

160 Participants

are divided into 4 treatment groups

Group A: IbuprofenExperimental treatment 1 intervention

Group B: ParacetamolExperimental treatment 1 intervention

Group C: TenoxicamExperimental treatment 1 intervention

Group D: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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

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.

Time frame

During ESWL procedure (up to 20 minutes)

Secondary outcomes

Stone-Free Rate After Extracorporeal Shock Wave Lithotripsy (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.

Time frame

Within 2-4 weeks after ESWL

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Gaziantep

Lead sponsor

Source ClinicalTrials.gov

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