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Not yet recruiting NCT07671612

PBM Patch for Postoperative Pain Relief After Urological Surgery

No phase Interventional Urological Surgery Photobiomodulation (PBM) Non-pharmacological Intervention Double-blind Randomized Controlled Study

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Super Vi PBM Patch - Soothing, Super Vi PBM Patch - Soothing EX, Placebo Patch.
Who it may be relevant to
Registry conditions: Urological Surgery, Photobiomodulation (PBM), Non-pharmacological Intervention, Double-blind Randomized Controlled Study. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • 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.
  • 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.
  • 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.

Primary outcome measures

  • Time-Weighted Mean Visual Analogue Scale (VAS) Pain Score at Rest [Time frame: Baseline (preoperatively), and 1 hour ±30 minutes, 2±1 hours, 6±2 hours, 12±2 hours, and 24±2 hours postoperatively]
Secondary outcome measures (5)
  • Total Postoperative Analgesic Consumption [Time frame: Up to 120 hours postoperatively]
  • Proportion of Patients Achieving Patient Acceptable Symptom State (PASS) [Time frame: 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 frame: From end of surgery to hospital discharge, assessed up to 5 days postoperatively]
  • Quality of Life Improvement [Time frame: Baseline (preoperative) to 120 hours postoperatively]
  • Safety Assessment [Time frame: Up to 120 hours postoperatively]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • Patients utilizing a Patient-Controlled Analgesia (PCA) pump.
  • Individuals with severe hepatic insufficiency or active liver disease.
  • Vulnerable populations, individuals with restricted legal capacity, or those who are unable or unwilling to undergo clinical evaluations.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Supportive care

Study locations

Taiwan · 2 centers
  • National Taiwan University Hospital — Taipei
  • National Taiwan University Cancer Center — Taipei

Identifiers

NCT: NCT07671612 · 202603101DINA、202603107DINA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗