UrolithiasisPhase 4ESWL-PAINNCT07512297
Pain Control During ESWL Using Non-Opioid Analgesics
A Phase 4 study testing Ibuprofen (Brufen®), Paracetamol (drug) and Tenoxicam in people with Urolithiasis and Kidney Stones, run by University of Gaziantep at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Urolithiasis, Kidney Stones, Ureteral Stones
- What is being tested?
- Ibuprofen (Brufen®), Paracetamol (drug) and Tenoxicam
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2026to 1 Mar 2027
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (≥18 years) undergoing ESWL for urinary stone disease
- Patients with kidney or ureteral stones indicated for ESWL
- Ability to provide informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Gaziantep University Faculty of Medicine Hospital
Gaziantep, Turkey
Mehmet Öztürk, +905393328554, mehmetozturk000@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Urolithiasis, Kidney Stones, Ureteral Stones
- Being tested
- Ibuprofen (Brufen®), Paracetamol (drug), Tenoxicam, Placebo
- Keywords
- ESWL, pain, Analgesia
- Medical subject headings
- Urolithiasis, Kidney Calculi, Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibuprofen (Brufen®)Drug
Ibuprofen administered prior to ESWL for pain control.
Paracetamol (drug)Drug
Paracetamol administered prior to ESWL for pain control.
TenoxicamDrug
Tenoxicam administered prior to ESWL for pain control.
PlaceboDrug
Placebo administered prior to ESWL.
| Study group | Role | What they receive |
|---|---|---|
| Ibuprofen | Experimental | Participants receive ibuprofen prior to ESWL for pain control. Receives: Drug: Ibuprofen (Brufen®) |
| Paracetamol | Experimental | Participants receive paracetamol prior to ESWL for pain control. Receives: Drug: Paracetamol (drug) |
| Tenoxicam | Experimental | Participants receive tenoxicam prior to ESWL for pain control. Receives: Drug: Placebo |
| Placebo | Placebo comparator | Participants receive placebo prior to ESWL. Receives: Drug: Tenoxicam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During ESWL procedure (up to 20 minutes)
Secondary outcomes (1)
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.
Measured: Within 2-4 weeks after ESWL
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for UrolithiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Gaziantep
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Öztürk, University of Gaziantep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07512297
- Sponsor's protocol ID
- GAUNIV-URO-ESWL-ANALG-26.03.61
- Acronym
- ESWL-PAIN
- Status last verified
- Aug 2026
- First submitted
- 30 Mar 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Publications
Waqas M, Butt A, Ayaz Khan M, Khan I, Saqib IU, Hussain T, Akhter S. Comparison of Different Analgesia Drug Regimens for Pain Control During Extracorporeal Shock Wave Lithotripsy for Renal Stones: A Randomized Control Study. Cureus. 2017 Apr 26;9(4):e1195. doi: 10.7759/cureus.1195.
PubMed 28560121Hu W, Yang K, Zhang L, Lu X. Effect of media distraction (audio-visual and music) for pain and anxiety control in patients undergoing shock-wave lithotripsy: A systematic review and meta-analysis. Exp Ther Med. 2021 Jun;21(6):623. doi: 10.3892/etm.2021.10055. Epub 2021 Apr 14.
PubMed 33936280