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Intraprostatic Anesthesia During Transperineal Prostate Biopsy (PRO-PAIN)

2 juli 2026 bijgewerkt door: Tarik Emre Sener, Marmara University

The Effect of Intraprostatic Local Anesthesia on Pain Perception During Transperineal Prostate Biopsy Under Local Anesthesia

Transperineal prostate biopsy has become the standard method for diagnosing prostate cancer because of its favorable safety profile and low infectious complication rates. However, pain and discomfort during the procedure remain important concerns that may negatively affect patient satisfaction and willingness to undergo repeat biopsy when necessary.

This prospective randomized controlled study aims to evaluate whether the addition of intraprostatic local anesthesia to standard perineal local anesthesia reduces pain during transperineal prostate biopsy. Fifty patients undergoing prostate biopsy under local anesthesia will be randomized into two groups. The first group will receive standard perineal local anesthesia, while the second group will receive additional intraprostatic local anesthesia.

Pain severity will be assessed before, during, and after the procedure using a visual analog scale (VAS). Anxiety and depression levels will be evaluated preoperatively using the Hospital Anxiety and Depression Scale (HADS). Patient-related factors, procedural characteristics, and post-procedural outcomes will also be recorded to identify factors associated with pain perception.

The results of this study may help optimize local anesthesia techniques and improve patient comfort during transperineal prostate biopsy.

Studie Overzicht

Toestand

Actief, niet wervend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Transperineal prostate biopsy is currently considered the preferred approach for prostate cancer diagnosis because of its low risk of infectious complications and favorable safety profile. Despite these advantages, pain experienced during the procedure remains a significant concern and may adversely affect patient satisfaction, procedural tolerance, and acceptance of repeat biopsy when clinically indicated.

Pain during prostate biopsy is primarily related to the rich autonomic innervation of the prostatic capsule and stroma. Perineal local anesthesia is commonly used to reduce procedural discomfort; however, pain may still occur, particularly during needle sampling of the prostatic parenchyma. Intraprostatic local anesthetic infiltration has been proposed as an adjunctive technique to provide more comprehensive analgesia by directly targeting the biopsy area. Previous studies have suggested that the addition of intraprostatic anesthesia may further reduce pain during prostate biopsy procedures.

The objective of this prospective randomized controlled study is to investigate the impact of intraprostatic local anesthesia on pain perception during transperineal prostate biopsy performed under local anesthesia. In addition, the study aims to evaluate the association between procedural pain and patient-related factors, including anxiety and depression levels assessed by the Hospital Anxiety and Depression Scale (HADS), as well as clinical and procedural characteristics.

The findings of this study may contribute to the optimization of local anesthesia protocols and improve patient comfort during transperineal prostate biopsy.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

50

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Turkije (Türkiye)
    • Pendik
      • Istanbul, Pendik, Turkije (Türkiye), 34722
        • Marmara University School of medicine

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  • Male patients aged 18 years or older
  • Clinical indication for transperineal prostate biopsy based on elevated prostate-specific antigen (PSA) level and/or suspicious digital rectal examination findings
  • Ability to understand and complete the Hospital Anxiety and Depression Scale (HADS)
  • Ability to provide pain scores using a 10-point Visual Analog Scale (VAS)
  • Provision of written informed consent

Exclusion Criteria:

  • Previous history of prostate biopsy
  • Known hypersensitivity or contraindication to local anesthetic agents
  • Hematological disorders affecting coagulation
  • Active urinary tract infection
  • Neurological disorders that may affect pain perception
  • Psychiatric disorders that may affect pain assessment or completion of study -questionnaires
  • Inability to complete the HADS questionnaire or VAS assessment
  • Refusal to participate or inability to provide informed consent

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Diagnostisch
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Perineal Local Anesthesia
Participants receive perineal local anesthesia consisting of infiltration of the perineal skin and subcutaneous tissues using a mixture of 5 mL prilocaine, 5 mL bupivacaine, and 10 mL normal saline before transperineal prostate biopsy.
Geneesmiddel: Prilocaine
Prilocaine is used as part of the local anesthetic mixture administered for perineal local anesthesia in both groups and for intraprostatic local anesthesia in the experimental group.
Geneesmiddel: Bupivacaine
Bupivacaine is used as part of the local anesthetic mixture administered for perineal local anesthesia in both groups and for intraprostatic local anesthesia in the experimental group.
Procedure: Perineal Local Anesthesia
Participants receive perineal local anesthesia consisting of infiltration of the perineal skin and subcutaneous tissues using a mixture of 5 mL prilocaine, 5 mL bupivacaine, and 10 mL normal saline before transperineal prostate biopsy.
Procedure: Transperineal Prostate Biopsy
Participants undergo standard transperineal prostate biopsy under local anesthesia according to the institutional biopsy protocol.
Apparaat: Transrectal Ultrasound (TRUS) System
A transrectal ultrasound (TRUS) system is used to provide real-time ultrasound guidance during transperineal prostate biopsy. The TRUS probe is inserted into the rectum to visualize the prostate and guide accurate needle placement through the perineum for systematic prostate biopsy under local anesthesia. The device is used in both study groups.
Experimenteel: Perineal Plus Intraprostatic Local Anesthesia
Participants receive standard perineal local anesthesia plus intraprostatic local anesthesia consisting of 5 mL of the same anesthetic mixture administered equally to both prostatic lobes before transperineal prostate biopsy.
Geneesmiddel: Prilocaine
Prilocaine is used as part of the local anesthetic mixture administered for perineal local anesthesia in both groups and for intraprostatic local anesthesia in the experimental group.
Geneesmiddel: Bupivacaine
Bupivacaine is used as part of the local anesthetic mixture administered for perineal local anesthesia in both groups and for intraprostatic local anesthesia in the experimental group.
Procedure: Perineal Local Anesthesia
Participants receive perineal local anesthesia consisting of infiltration of the perineal skin and subcutaneous tissues using a mixture of 5 mL prilocaine, 5 mL bupivacaine, and 10 mL normal saline before transperineal prostate biopsy.
Procedure: Transperineal Prostate Biopsy
Participants undergo standard transperineal prostate biopsy under local anesthesia according to the institutional biopsy protocol.
Apparaat: Transrectal Ultrasound (TRUS) System
A transrectal ultrasound (TRUS) system is used to provide real-time ultrasound guidance during transperineal prostate biopsy. The TRUS probe is inserted into the rectum to visualize the prostate and guide accurate needle placement through the perineum for systematic prostate biopsy under local anesthesia. The device is used in both study groups.
Procedure: Intraprostatic Local Anesthesia
Participants receive intraprostatic local anesthesia consisting of 5 mL of the same anesthetic mixture administered equally to both prostatic lobes during transperineal prostate biopsy.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Pain During Transperineal Prostate Biopsy
Tijdsspanne: During the biopsy procedure
Pain severity during transperineal prostate biopsy will be assessed using the Visual Analog Scale (VAS), a patient-reported pain scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate greater pain severity. Pain scores will be compared between participants receiving perineal local anesthesia alone and those receiving additional intraprostatic local anesthesia.
During the biopsy procedure

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Marmara University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 november 2025

Primaire voltooiing (Werkelijk)

1 juni 2026

Studie voltooiing (Geschat)

1 september 2026

Studieregistratiedata

Eerst ingediend

8 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

2 juli 2026

Eerst geplaatst (Werkelijk)

6 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

6 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

2 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • MAR.UAD.0033

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

Individual participant data (IPD) will not be publicly shared in order to protect participant confidentiality and comply with ethical and institutional requirements. De-identified data may be made available upon reasonable request for scientifically and medically justified purposes, subject to review and approval by the principal investigator.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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