Comparative Evaluation of Non-Opioid Analgesics for Pain Control During Extracorporeal Shock Wave Lithotripsy: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Pain Intensity During ESWL Measured by Visual Analog Scale (VAS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (≥18 years) undergoing ESWL for urinary stone disease
- •Patients with kidney or ureteral stones indicated for ESWL
- •Ability to provide informed consent
排除标准
- •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
研究组 & 干预措施
Placebo
Participants receive placebo prior to ESWL.
干预措施: Tenoxicam (Drug)
Tenoxicam
Participants receive tenoxicam prior to ESWL for pain control.
干预措施: Placebo (Drug)
Ibuprofen
Participants receive ibuprofen prior to ESWL for pain control.
干预措施: Ibuprofen (Brufen®) (Drug)
Paracetamol
Participants receive paracetamol prior to ESWL for pain control.
干预措施: Paracetamol (drug) (Drug)
结局指标
主要结局
Pain Intensity During ESWL Measured by Visual Analog Scale (VAS)
时间窗: During ESWL procedure (up to 20 minutes)
Pain intensity will be assessed using the Visual Analog Scale (VAS, 0-10) at the 5th, 10th, 15th, and 20th minutes during the ESWL procedure. VAS scores will be compared between treatment groups.
Pain Intensity During Extracorporeal Shock Wave Lithotripsy (ESWL) Measured by Visual Analog Scale (VAS)
时间窗: 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.
次要结局
- Stone-Free Rate After ESWL(Within 2-4 weeks after ESWL)
- Stone-Free Rate After Extracorporeal Shock Wave Lithotripsy (ESWL)(Within 2-4 weeks after ESWL)
研究者
Mehmet Öztürk
Asst. Prof. Dr.
University of Gaziantep