Palmitoylethanolamide Versus Ibuprofen for Acute Postoperative Pain After Extracorporeal Shock Wave Lithotripsy: A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Postoperative pain intensity measured by Visual Analogue Scale (VAS)
研究概览
简要总结
Pain after extracorporeal shock wave lithotripsy (ESWL), a non-surgical procedure used to treat kidney stones, is common and is usually treated with non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen. However, NSAIDs may cause side effects in some patients, including stomach irritation and kidney problems.
Palmitoylethanolamide (PEA) is a naturally occurring substance in the body with anti-inflammatory and pain-relieving properties and has been shown to be safe in previous studies. This study aims to compare the effectiveness of PEA with ibuprofen for controlling acute postoperative pain after ESWL.
Participants undergoing ESWL will be randomly assigned to receive either oral PEA or oral ibuprofen. Pain intensity will be measured using a visual analogue scale during the first 24 hours after the procedure. The use of rescue pain medication and any side effects will also be recorded.
The results of this study may help determine whether PEA can be an effective alternative to ibuprofen for the management of acute pain after ESWL.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years
- •ASA I or II
- •Undergoing elective ESWL for renal or upper ureteric calculi
- •Expected discharge same day or within 24 hours (outpatient ESWL).
- •Able to provide informed consent and comply with study procedures (including diary/VAS recordings).
- •Not currently taking chronic NSAIDs, opioids, or PEA supplements for ≥7 days prior to ESWL.
排除标准
- •Chronic pain or daily analgesic use.
- •Known allergy or contraindication to PEA, ibuprofen.
- •Active peptic ulcer disease, known bleeding disorder, anticoagulant therapy
- •Pregnancy or lactation.
- •Use of steroids or other pain-modulating drugs.
- •Severe renal impairment (eGFR <30 mL/min/1.73 m²).
- •Hepatic failure or significant liver enzyme elevation (AST/ALT >3× ULN).
研究组 & 干预措施
Palmitoylethanolamide Group
Participants assigned to this arm will receive oral palmitoylethanolamide for management of acute postoperative pain following extracorporeal shock wave lithotripsy (ESWL). Rescue analgesia will be available if required.
干预措施: Palmitoylethanolamide (PEA) (Drug)
Ibuprofen Group
Participants assigned to this arm will receive oral ibuprofen for management of acute postoperative pain following extracorporeal shock wave lithotripsy (ESWL). Rescue analgesia will be available if required.
干预措施: Ibuprofen (Brufen®) (Drug)
结局指标
主要结局
Postoperative pain intensity measured by Visual Analogue Scale (VAS)
时间窗: 2 hours after ESWL
Pain intensity will be assessed using a 10-cm visual analogue scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. The primary comparison will be the VAS score measured 2 hours after extracorporeal shock wave lithotripsy (ESWL) between the palmitoylethanolamide and ibuprofen groups.
次要结局
- Pain intensity over the first 24 hours after ESWL(From recovery room arrival up to 24 hours after ESWL)
- Time to first rescue analgesia(Up to 24 hours after ESWL)
- Total rescue analgesic consumption within 24 hours(Up to 24 hours after ESWL)
- Proportion of patients achieving clinically meaningful pain relief(Within 24 hours after ESWL)
- Incidence of adverse events(From first dose of study medication up to 7 days after ESWL)
研究者
Samar Rafik Mohamed Amin
assistant professor
Benha University