Pain Control During ESWL Using Non-Opioid Analgesics

NCT07512297 | Not Yet Recruiting Phase 4

• 1 other identifier: GAUNIV-URO-ESWL-ANALG-26.03.61
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Urolithiasis; Kidney Stones; Ureteral Stones

Keywords

ESWL; pain; Analgesia

Outcome Measures

Primary Outcomes (1)

• 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.

  During ESWL procedure (up to 20 minutes)

Secondary Outcomes (1)

• Stone-Free Rate After Extracorporeal Shock Wave Lithotripsy (ESWL)

  Within 2-4 weeks after ESWL

Study Arms (4)

Ibuprofen

EXPERIMENTAL

Participants receive ibuprofen prior to ESWL for pain control.

Drug: Ibuprofen (Brufen®)

Paracetamol

EXPERIMENTAL

Participants receive paracetamol prior to ESWL for pain control.

Drug: Paracetamol (drug)

Tenoxicam

EXPERIMENTAL

Participants receive tenoxicam prior to ESWL for pain control.

Drug: Placebo

Placebo

PLACEBO COMPARATOR

Participants receive placebo prior to ESWL.

Drug: Tenoxicam

Interventions

Ibuprofen (Brufen®) DRUG

Ibuprofen administered prior to ESWL for pain control.

Ibuprofen

Paracetamol (drug) DRUG

Paracetamol administered prior to ESWL for pain control.

Paracetamol

Tenoxicam DRUG

Tenoxicam administered prior to ESWL for pain control.

Placebo

Placebo DRUG

Placebo administered prior to ESWL.

Tenoxicam

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (≥18 years) undergoing ESWL for urinary stone disease
• Patients with kidney or ureteral stones indicated for ESWL
• Ability to provide informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Gaziantep: lead

Study Sites (1)

Gaziantep University Faculty of Medicine Hospital

Gaziantep, Turkey, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 28560121 BACKGROUND

• Hu 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.

  PMID: 33936280 BACKGROUND

MeSH Terms

Conditions

Urolithiasis; Kidney Calculi; Pain; Agnosia

Interventions

Ibuprofen; Acetaminophen; Pharmaceutical Preparations; tenoxicam

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Nephrolithiasis; Kidney Diseases; Urinary Calculi; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Central Study Contacts

Mehmet Öztürk

CONTACT

+905393328554; mehmetozturk000@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof. Dr.

Model Details: 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.

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 6, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

TU (1)