Double-blind Randomized Controlled Study, Non-pharmacological Intervention, Photobiomodulation (PBM), Postoperative Pain Relief, Urological Surgery
Conditions
Keywords
Postoperative Pain Relief, Photobiomodulation (PBM), Urological Surgery, Double-blind Randomized Controlled Study, Non-pharmacological Intervention
Brief summary
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).
Interventions
DEVICESuper Vi PBM Patch - Soothing
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.
DEVICESuper Vi PBM Patch - Soothing EX
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.
DEVICEPlacebo Patch
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.
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients aged 18 years or older undergoing unilateral nephroureterectomy with bladder cuff excision, or adrenalectomy (tumor size \< 3.5 cm). 2. Patients who are capable of clear verbal communication. 3. Patients who are able to provide written informed consent.
Exclusion criteria
1. Individuals with photosensitive constitution or those currently using photosensitizing medications. 2. Individuals with a known history of severe allergy or contact dermatitis to medical adhesive patches or tapes. 3. Patients with severe psychiatric illness or cognitive impairment. 4. Long-term or high-dose opioid users. 5. Patients utilizing a Patient-Controlled Analgesia (PCA) pump. 6. Individuals with severe hepatic insufficiency or active liver disease. 7. Vulnerable populations, individuals with restricted legal capacity, or those who are unable or unwilling to undergo clinical evaluations.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time-Weighted Mean Visual Analogue Scale (VAS) Pain Score at Rest | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Postoperative Analgesic Consumption | Up to 120 hours postoperatively | 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) | 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 | 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 | From end of surgery to hospital discharge, assessed up to 5 days postoperatively | 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 | Baseline (preoperative) to 120 hours postoperatively | 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. |
| Safety Assessment | Up to 120 hours postoperatively | 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). |
Countries
Taiwan
Contacts
CONTACTShih-Chieh Chueh, Attending Physicia / Professor
Outcome results
None listed