A Double-blind Randomized Controlled Clinical Study of the PBM Patch for Postoperative Pain Relief After Urological Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Time-Weighted Mean Visual Analogue Scale (VAS) Pain Score at Rest
研究概览
简要总结
This study is a prospective, randomized, double-blind, placebo-controlled clinical study designed to evaluate the efficacy and safety of a photobiomodulation (PBM) patch (Super Vi PBM Patch - Soothing) and an enhanced PBM patch (Super Vi PBM Patch - Soothing EX), compared with a placebo patch, for postoperative pain relief following urological surgery, including nephroureterectomy with bladder cuff resection (NU+BCR) and adrenalectomy (ADRX).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 years or older undergoing unilateral nephroureterectomy with bladder cuff excision, or adrenalectomy (tumor size < 3.5 cm).
- •Patients who are capable of clear verbal communication.
- •Patients who are able to provide written informed consent.
排除标准
- •Individuals with photosensitive constitution or those currently using photosensitizing medications.
- •Individuals with a known history of severe allergy or contact dermatitis to medical adhesive patches or tapes.
- •Patients with severe psychiatric illness or cognitive impairment.
- •Long-term or high-dose opioid users.
- •Patients utilizing a Patient-Controlled Analgesia (PCA) pump.
- •Individuals with severe hepatic insufficiency or active liver disease.
- •Vulnerable populations, individuals with restricted legal capacity, or those who are unable or unwilling to undergo clinical evaluations.
结局指标
主要结局
Time-Weighted Mean Visual Analogue Scale (VAS) Pain Score at Rest
时间窗: Baseline (preoperatively), and 1 hour ±30 minutes, 2±1 hours, 6±2 hours, 12±2 hours, and 24±2 hours postoperatively
The preoperative baseline VAS pain score at rest will be recorded before surgery. Postoperative VAS pain scores at rest will be assessed at 1 hour ±30 minutes, 2±1 hours, 6±2 hours, 12±2 hours, and 24±2 hours after surgery. The time-weighted mean VAS pain score at rest (Scale: 0-100 mm; higher scores indicate worse pain) during the first 24 hours postoperatively will be analyzed using a mixed model for repeated measures (MMRM). Sensitivity analysis will be performed using the area under the curve from baseline to 120 hours (AUC₀-₁₂₀h) with an analysis of covariance (ANCOVA) model.
次要结局
- Total Postoperative Analgesic Consumption(Up to 120 hours postoperatively)
- Proportion of Patients Achieving Patient Acceptable Symptom State (PASS)(1 hour ±30 minutes, 2±1 hours, 6±2 hours, 12±2 hours, 24±2 hours, 48±2 hours, 72±2 hours, 96±2 hours, and 120±2 hours postoperatively)
- Clinical Recovery Progress(From end of surgery to hospital discharge, assessed up to 5 days postoperatively)
- Quality of Life Improvement(Baseline (preoperative) to 120 hours postoperatively)
- Safety Assessment(Up to 120 hours postoperatively)