Intraprostatic Anesthesia During Transperineal Prostate Biopsy

NCT07683182 | Active Not Recruiting

• 1 other identifier: MAR.UAD.0033
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer (Diagnosis); Prostate-Specific Antigen

Keywords

Transperineal Prostate Biopsy; Intraprostatic Anesthesia; Local Anesthesia; Pain Assessment

Outcome Measures

Primary Outcomes (1)

• Pain During Transperineal Prostate Biopsy

  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

Study Arms (2)

Perineal Local Anesthesia

ACTIVE COMPARATOR

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.

Drug: Prilocaine; Drug: Bupivacaine; Procedure: Perineal Local Anesthesia; Procedure: Transperineal Prostate Biopsy; Device: Transrectal Ultrasound (TRUS) System

Perineal Plus Intraprostatic Local Anesthesia

EXPERIMENTAL

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.

Drug: Prilocaine; Drug: Bupivacaine; Procedure: Perineal Local Anesthesia; Procedure: Intraprostatic Local Anesthesia; Procedure: Transperineal Prostate Biopsy; Device: Transrectal Ultrasound (TRUS) System

Interventions

Prilocaine DRUG

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.

Perineal Local Anesthesia; Perineal Plus Intraprostatic Local Anesthesia

Bupivacaine DRUG

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.

Perineal Local Anesthesia; Perineal Plus Intraprostatic Local Anesthesia

Perineal Local Anesthesia PROCEDURE

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.

Perineal Local Anesthesia; Perineal Plus Intraprostatic Local Anesthesia

Intraprostatic Local Anesthesia PROCEDURE

Participants receive intraprostatic local anesthesia consisting of 5 mL of the same anesthetic mixture administered equally to both prostatic lobes during transperineal prostate biopsy.

Perineal Plus Intraprostatic Local Anesthesia

Transperineal Prostate Biopsy PROCEDURE

Participants undergo standard transperineal prostate biopsy under local anesthesia according to the institutional biopsy protocol.

Perineal Local Anesthesia; Perineal Plus Intraprostatic Local Anesthesia

Transrectal Ultrasound (TRUS) System DEVICE

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.

Perineal Local Anesthesia; Perineal Plus Intraprostatic Local Anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University School of Medicine

Istanbul, Pendik, 34722, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Disease

Interventions

Prilocaine; Bupivacaine; Drug Delivery Systems

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded to the assigned anesthesia technique. The urologist performing the biopsy will not be blinded due to the nature of the intervention. Pain scores and study outcomes will be assessed and analyzed by an outcomes assessor who is blinded to group allocation.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assos. Prof.

Model Details: Participants will be randomized in a 1:1 ratio to receive either standard perineal local anesthesia alone or perineal local anesthesia combined with intraprostatic local anesthesia during transperineal prostate biopsy. Pain scores before, during, and after the procedure will be compared between the two parallel study groups.

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: July 6, 2026
• Study Start: November 1, 2025
• Primary Completion: June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 6, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)