PBM Patch for Postoperative Pain Relief After Urological Surgery

N/ANot Yet RecruitingNCT07671612

National Taiwan University Hospital300 enrolled

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

300

Conditions

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

Interventions

Super Vi PBM Patch - SoothingDEVICE

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.

Super Vi PBM Patch - Soothing EXDEVICE

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 PatchDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: Baseline (preoperatively), and 1 hour ±30 minutes, 2±1 hours, 6±2 hours, 12±2 hours, and 24±2 hours postoperatively

Secondary Outcomes

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.

Time frame: 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.

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 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.

Time frame: 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.

Time frame: 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).