Comparative Evaluation of Non-Opioid Analgesics for Pain Control During Extracorporeal Shock Wave Lithotripsy: A Prospective Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- University of Gaziantep
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- Pain Intensity During Extracorporeal Shock Wave Lithotripsy (ESWL) Measured by Visual Analog Scale (VAS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, 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.
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Ibuprofen
Participants receive ibuprofen prior to ESWL for pain control.
Intervention: Ibuprofen (Brufen®) (Drug)
Tenoxicam
Participants receive tenoxicam prior to ESWL for pain control.
Intervention: Placebo (Drug)
Paracetamol
Participants receive paracetamol prior to ESWL for pain control.
Intervention: Paracetamol (drug) (Drug)
Placebo
Participants receive placebo prior to ESWL.
Intervention: Tenoxicam (Drug)
Outcomes
Primary Outcomes
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
- Stone-Free Rate After Extracorporeal Shock Wave Lithotripsy (ESWL)(Within 2-4 weeks after ESWL)
Investigators
Mehmet Öztürk
Asst. Prof. Dr.
University of Gaziantep