PBM Patch for Postoperative Pain Relief After Urological Surgery

A Double-blind Randomized Controlled Clinical Study of the PBM Patch for Postoperative Pain Relief After Urological Surgery

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Pain Relief; Urological Surgery; Photobiomodulation (PBM); Non-pharmacological Intervention; Double-blind Randomized Controlled Study
• Intervention / Treatment: Device: Super Vi PBM Patch - Soothing; Device: Super Vi PBM Patch - Soothing EX; Device: Placebo Patch

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shih-Chieh Chueh, Attending Physicia / Professor; Phone Number: 62135 +886-2-3123456; Email: scchueh@ntu.edu.tw

Study Locations

• Taiwan
  • Taipei City
    • Taipei, Taipei City, Taiwan, 100
      • National Taiwan University Hospital
      • Contact: Shih-Chieh Chueh, M.D.; Phone Number: 62135 +886-2-3123456; Email: scchueh@ntu.edu.tw
    • Taipei, Taipei City, Taiwan, 106
      • National Taiwan University Cancer Center
      • Contact: Wei-Che Wu, M.D.; Phone Number: +886972652979; Email: A01827@ntucc.gov.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Super Vi PBM Patch - Soothing; The Super Vi PBM Patch - Soothing will be applied to the participant immediately upon arrival in the post-anesthesia care unit (PACU) after surgery.	Device: Super 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.
Experimental: Super Vi PBM Patch - Soothing EX; 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.	Device: Super 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.
Placebo Comparator: Placebo Patch; The Placebo Patch will be applied to the participant immediately upon arrival in the post-anesthesia care unit (PACU) after surgery.	Device: Placebo 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): March 31, 2028

Study Registration Dates

• First Submitted: June 18, 2026
• First Submitted That Met QC Criteria: June 25, 2026
• First Posted (Actual): June 26, 2026

Study Record Updates

• Last Update Posted (Actual): June 26, 2026
• Last Update Submitted That Met QC Criteria: June 25, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Urological Surgery; Non-pharmacological Intervention; Postoperative Pain Relief; Photobiomodulation (PBM); Double-blind Randomized Controlled Study
• Other Study ID Numbers: 202603101DINA、202603107DINA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: It is not yet determined whether individual participant data will be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No