Urolithiasis, Kidney Stones, Ureteral Stones
Conditions
Keywords
ESWL, pain, Analgesia
Brief 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.
Interventions
Ibuprofen administered prior to ESWL for pain control.
Paracetamol administered prior to ESWL for pain control.
DRUGTenoxicam
Tenoxicam administered prior to ESWL for pain control.
DRUGPlacebo
Placebo administered prior to ESWL.
Sponsors
University of Gaziantep
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Participants and care providers were blinded to the assigned intervention. Analgesic medications were prepared and administered in a standardized manner to ensure that the treatment allocation remained concealed throughout the study.
Intervention model description
Participants will be randomly assigned to one of four parallel groups receiving ibuprofen, paracetamol, tenoxicam, or placebo prior to ESWL. Each participant will receive only one intervention, and outcomes will be compared across groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity During Extracorporeal Shock Wave Lithotripsy (ESWL) Measured by Visual Analog Scale (VAS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Stone-Free Rate After Extracorporeal Shock Wave Lithotripsy (ESWL) | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTMehmet Öztürk
Outcome results
None listed