Impact of Local Anesthesia Type on Cancer Detection Rate in Transrectal Ultrasound Guided Prostate Biopsy

Phase 4

Completed

• Conditions: Adenocarcinoma of Prostate
• Interventions: Drug: intrarectal lidocaine gel; Drug: periprostatic nerve blockade

• Registration Number: NCT02025361
• Lead Sponsor: Bagcilar Training and Research Hospital

Brief Summary

Transrectal ultrasound guided prostate biopsy (TRUS-Bx) is the gold standard method for prostat cancer diagnosis. Cancer detection rate is an important issue in TRUS-Bx. Effective biopsy protocol is necessary to enhance cancer detection rate during the procedure. Patient tolerance may improve the protocol effectiveness and quality.

Adequate patient tolerance with optimal local anesthesia may enhance cancer detection rate in TRUS-Bx.

Detailed Description

In transrectal ultrasound guided prostate biopsy ultrasound's probe manipulation is necessary for effective biopsy. Patient discomfort and pain frequently occurs with manipulation of probe during transrectal ultrasound guided prostate biopsy and this situation may qualify of the achievement of this procedure.

In this study, we aimed to describe the impact of different two local anesthesia types on cancer detection rate in transrectal ultrasound guided prostate biopsy.

Study Timeline

• Study Start: 2009-02
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Study First Submitted: 2013-12-17
• Study First Submitted QC: 2013-12-30
• Study First Posted: 2014-01-01
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-16
• Last Update Posted: 2018-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 422

Inclusion Criteria

• Patients who underwent transrectal ultrasound guided prostate biopsy because of elevated serum PSA levels and/or suspicious rectal examination of prostate.

Exclusion Criteria

• Previous TRUS-Bx and prostatic operations(TUR-P, open prostatectomy, etc..) history, treatment for prostate carcinoma, usage of finasteride and dutasteride.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
intrarectal lidocaine gel	intrarectal lidocaine gel	transrectal ultrasound guided prostate biopsy was performed with intrarectal lidocaine gel anesthesia: 10 minutes before the procedure % 2 lidocaine hydrochloride gel instilated into the rectum for local anesthesia
periprostatic nerve blockade	periprostatic nerve blockade	transrectal ultrasound guided prostate biopsy was performed with intrarectal lidocaine gel anesthesia: 10 minutes before the procedure transrectal ultrasound guided 10 ml prilocaine and serum physiologic blend (5ml %2 prilocaine and 5 ml serum physiologic) injected separetly 5ml right and 5ml left junction between the prostate base and seminal vesicle.

Primary Outcome Measures

Name	Time	Method
cancer detection rate with anesthesia type	finally pathologic evaluation within 2-3 weeks

Trial Locations

Locations (1)

Bagcilar Training and Research Hospital-Depertmant of urology; 🇹🇷 Istanbul, Bagcilar, Turkey