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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Super Vi PBM Patch - Soothing | Experimental | The Super Vi PBM Patch - Soothing will be applied to the participant immediately upon arrival in the post-anesthesia care unit (PACU) after surgery. |
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| Super Vi PBM Patch - Soothing EX | Experimental | The Super Vi PBM Patch - Soothing EX will be applied to the participant immediately upon arrival in the post-anesthesia care unit (PACU) after surgery. |
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| Placebo Patch | Placebo Comparator | The Placebo Patch will be applied to the participant immediately upon arrival in the post-anesthesia care unit (PACU) after surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Super Vi PBM Patch - Soothing | Device | A 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (preoperatively), and 1 hour ±30 minutes, 2±1 hours, 6±2 hours, 12±2 hours, and 24±2 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shih-Chieh Chueh, Attending Physicia / Professor | Contact | +886-2-3123456 | 62135 | scchueh@ntu.edu.tw |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Taipei | Taipei City | 100 | Taiwan |
It is not yet determined whether individual participant data will be shared with other researchers.
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| Super Vi PBM Patch - Soothing EX | Device | A 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. |
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| Placebo Patch | Device | An 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. |
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| Up to 120 hours postoperatively |
| 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. | 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 | 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. | From end of surgery to hospital discharge, assessed up to 5 days postoperatively |
| 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. | Baseline (preoperative) to 120 hours postoperatively |
| Safety Assessment | Detailed recording of all adverse events occurring during the study period, including patch-site skin reactions (e.g., erythema, itching, rash) and analgesic-related side effects (e.g., nausea, vomiting, dizziness). | Up to 120 hours postoperatively |
| National Taiwan University Cancer Center | Taipei | Taipei City | 106 | Taiwan |
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