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

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

Sponsors

Lead sponsor: Bagcilar Training and Research Hospital

Source 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.

Overall Status Completed
Start Date February 2009
Completion Date December 2012
Primary Completion Date December 2012
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
cancer detection rate with anesthesia type finally pathologic evaluation within 2-3 weeks
Enrollment 422
Condition
Intervention

Intervention type: Drug

Intervention name: intrarectal lidocaine gel

Description: intrarectal local anesthetic application

Arm group label: intrarectal lidocaine gel

Other name: No name

Intervention type: Drug

Intervention name: periprostatic nerve blockade

Description: periprostatic local anesthetic application

Arm group label: periprostatic nerve blockade

Other name: No name

Eligibility

Criteria:

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.

Gender: Male

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
mustafa z temiz Principal Investigator bagcilar training and research hospital-depertmant of urology
Location
facility Bagcilar Training and Research Hospital-Depertmant of urology
Location Countries

Turkey

Verification Date

January 2018

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Bagcilar Training and Research Hospital

Investigator full name: Mustafa Zafer Temiz

Investigator title: principal investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: intrarectal lidocaine gel

Arm group type: Experimental

Description: 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

Arm group label: periprostatic nerve blockade

Arm group type: Experimental

Description: 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.

Patient Data No
Study Design Info

Allocation: Non-Randomized

Intervention model: Factorial Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Source: ClinicalTrials.gov