Intraprostatic Anesthesia During Transperineal Prostate Biopsy

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

Interventions

DRUG

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.

DRUG

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

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.

PROCEDURE

Transperineal Prostate Biopsy

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

DEVICE

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.

Sponsors & Collaborators

• Marmara University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-11-01

Primary Completion

2026-06-01

Completion

2026-09-01

Countries

• Turkey (Türkiye)

Study Locations