Intraprostatic Anesthesia During Transperineal Prostate Biopsy (PRO-PAIN)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Prostate-Specific Antigen; Prostate Cancer (Diagnosis)
• Intervention / Treatment: Drug: Prilocaine; Drug: Bupivacaine; Procedure: Perineal Local Anesthesia; Procedure: Transperineal Prostate Biopsy; Device: Transrectal Ultrasound (TRUS) System; Procedure: Intraprostatic Local Anesthesia

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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: 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.
Experimental: 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.	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: 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Marmara University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2025
• Primary Completion (Actual): June 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: June 8, 2026
• First Submitted That Met QC Criteria: July 2, 2026
• First Posted (Actual): July 6, 2026

Study Record Updates

• Last Update Posted (Actual): July 6, 2026
• Last Update Submitted That Met QC Criteria: July 2, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Transperineal Prostate Biopsy; Local Anesthesia; Pain Assessment; Intraprostatic Anesthesia
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Pathological Conditions, Signs and Symptoms; Prostatic Neoplasms; Disease; Organic Chemicals; Therapeutics; Drug Therapy; Anilides; Amides; Aniline Compounds; Amines; Bupivacaine; Prilocaine; Drug Delivery Systems
• Other Study ID Numbers: MAR.UAD.0033

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No