PBM Patch for Postoperative Pain Relief After Urological Surgery
25. juni 2026 oppdatert av: National Taiwan University Hospital
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).
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
300
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Shih-Chieh Chueh, Attending Physicia / Professor
- Telefonnummer: 62135 +886-2-3123456
- E-post: scchueh@ntu.edu.tw
Studiesteder
-
-
Taipei City
-
Taipei, Taipei City, Taiwan, 100
- National Taiwan University Hospital
-
Ta kontakt med:
- Shih-Chieh Chueh, M.D.
- Telefonnummer: 62135 +886-2-3123456
- E-post: scchueh@ntu.edu.tw
-
Taipei, Taipei City, Taiwan, 106
- National Taiwan University Cancer Center
-
Ta kontakt med:
- Wei-Che Wu, M.D.
- Telefonnummer: +886972652979
- E-post: A01827@ntucc.gov.tw
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
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.
|
|
Eksperimentell: 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.
|
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 komparator: Placebo Patch
The Placebo Patch will be applied to the participant immediately upon arrival in the post-anesthesia care unit (PACU) after surgery.
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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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Time-Weighted Mean Visual Analogue Scale (VAS) Pain Score at Rest
Tidsramme: 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.
|
Baseline (preoperatively), and 1 hour ±30 minutes, 2±1 hours, 6±2 hours, 12±2 hours, and 24±2 hours postoperatively
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Total Postoperative Analgesic Consumption
Tidsramme: 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.
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Up to 120 hours postoperatively
|
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Proportion of Patients Achieving Patient Acceptable Symptom State (PASS)
Tidsramme: 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.
|
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
|
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Clinical Recovery Progress
Tidsramme: From end of surgery to hospital discharge, assessed up to 5 days postoperatively
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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.
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From end of surgery to hospital discharge, assessed up to 5 days postoperatively
|
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Quality of Life Improvement
Tidsramme: Baseline (preoperative) to 120 hours postoperatively
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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.
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Baseline (preoperative) to 120 hours postoperatively
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Safety Assessment
Tidsramme: Up to 120 hours postoperatively
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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).
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Up to 120 hours postoperatively
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. juli 2026
Primær fullføring (Antatt)
28. februar 2028
Studiet fullført (Antatt)
31. mars 2028
Datoer for studieregistrering
Først innsendt
18. juni 2026
Først innsendt som oppfylte QC-kriteriene
25. juni 2026
Først lagt ut (Faktiske)
26. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
26. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
25. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 202603101DINA、202603107DINA
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
UBESLUTTE
IPD-planbeskrivelse
It is not yet determined whether individual participant data will be shared with other researchers.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Nei
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