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Intraprostatic Anesthesia During Transperineal Prostate Biopsy (PRO-PAIN)

2. juli 2026 opdateret af: 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.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

50

Fase

  • Ikke anvendelig

Kontakter og lokationer

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Studiesteder

  • Tyrkiet (Türkiye)
    • Pendik
      • Istanbul, Pendik, Tyrkiet (Türkiye), 34722
        • Marmara University School of Medicine

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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.
Medicin: 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.
Medicin: 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.
Enhed: 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.
Eksperimentel: 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.
Medicin: 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.
Medicin: 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.
Enhed: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pain During Transperineal Prostate Biopsy
Tidsramme: 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

Samarbejdspartnere og efterforskere

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Sponsor

Marmara University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. november 2025

Primær færdiggørelse (Faktiske)

1. juni 2026

Studieafslutning (Anslået)

1. september 2026

Datoer for studieregistrering

Først indsendt

8. juni 2026

Først indsendt, der opfyldte QC-kriterier

2. juli 2026

Først opslået (Faktiske)

6. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MAR.UAD.0033

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

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