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).
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.
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.
Parallel
Super Vi PBM Patch - Soothing
DeviceA photobiomodulation (PBM) patch designed for postoperative pain relief. The patch will be applied immediately upon arrival in the post-anesthesia care unit (PACU) after urological surgery.
Super Vi PBM Patch - Soothing EX
DeviceA photobiomodulation (PBM) patch designed for postoperative pain relief. The patch will be applied immediately upon arrival in the post-anesthesia care unit (PACU) after urological surgery.
Placebo Patch
DeviceAn placebo patch visually identical to the study patches but without therapeutic photobiomodulation delivery. The patch will be applied immediately upon arrival in the post-anesthesia care unit (PACU) after urological surgery.
Time-Weighted Mean Visual Analogue Scale (VAS) Pain Score at Rest
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.
Total Postoperative Analgesic Consumption
Comparison of the frequency and total dosage of analgesic use among the three groups within 120 hours postoperatively. Analgesics include non-opioids (e.g., Acetaminophen, NSAIDs) and opioids (e.g., Morphine, Tramadol). Opioid use will be converted to Morphine Milligram Equivalents (MME) for standardized comparison, in order to evaluate and verify the opioid-sparing effect of the study patch.
Proportion of Patients Achieving Patient Acceptable Symptom State (PASS)
Proportion of participants in each group achieving Patient Acceptable Symptom State (PASS), defined as a Visual Analogue Scale (VAS) pain score of ≤33 mm (scale: 0-100 mm; higher scores indicate worse pain) at 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, used to assess patient satisfaction with pain control.
Clinical Recovery Progress
Time to first ambulation out of bed and length of postoperative hospital stay will be recorded and compared among the three groups, to evaluate whether patch treatment accelerates the clinical recovery process.
Quality of Life Improvement
Change in quality of life from preoperative baseline to 120 hours postoperatively, assessed using the Traditional Chinese version of the EQ-5D-5L questionnaire (EuroQol 5-Dimension 5-Level). Higher index scores indicate better health-related quality of life. The EQ Visual Analogue Scale (EQ-VAS) will be reported as a supplementary measure, with higher scores indicating better self-rated health.
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