PBM Patch for Postoperative Pain Relief After Urological Surgery

ClinicalTrials.gov ID

NCT07671612

Lead Sponsor

National Taiwan University HospitalOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

300Estimated

Last Update Posted

Jun 26, 2026Actual

Start Date

Jul 1, 2026Estimated

Primary Completion Date

Feb 28, 2028Estimated

Completion Date

Mar 31, 2028Estimated

Official Title

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

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).

• Urological Surgery
• Photobiomodulation (PBM)
• Non-pharmacological Intervention
• Double-blind Randomized Controlled Study
• Postoperative Pain Relief

• Super Vi PBM Patch - Soothing
• Super Vi PBM Patch - Soothing EX
• Placebo Patch

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Primary Purpose

Supportive Care

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Triple

Lead Sponsor

National Taiwan University HospitalOTHER

A01827@ntucc.gov.tw+886972652979

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