Pain Control During ESWL Using Non-Opioid Analgesics

Официальное название

Comparative Evaluation of Non-Opioid Analgesics for Pain Control During Extracorporeal Shock Wave Lithotripsy: A Prospective Randomized Controlled Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Ibuprofen (Brufen®)
  Ibuprofen administered prior to ESWL for pain control.
• Препарат Paracetamol (drug)
  Paracetamol administered prior to ESWL for pain control.
• Препарат Tenoxicam
  Tenoxicam administered prior to ESWL for pain control.
• Препарат Placebo
  Placebo administered prior to ESWL.

Первичные конечные точки

• Pain Intensity During Extracorporeal Shock Wave Lithotripsy (ESWL) Measured by Visual Analog Scale (VAS) [Срок оценки: During ESWL procedure (up to 20 minutes)]

Вторичные конечные точки (1)

• Stone-Free Rate After Extracorporeal Shock Wave Lithotripsy (ESWL) [Срок оценки: Within 2-4 weeks after ESWL]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Gaziantep University Faculty of Medicine Hospital — Gaziantep

Публикации

• 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
• 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

Идентификаторы

NCT: NCT07512297 · GAUNIV-URO-ESWL-ANALG-26.03.61

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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