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

B

Bagcilar Training and Research Hospital

Status and phase

Completed
Phase 4

Conditions

Adenocarcinoma of Prostate

Treatments

Drug: periprostatic nerve blockade
Drug: intrarectal lidocaine gel

Study type

Interventional

Funder types

Other

Identifiers

NCT02025361
Cancer detection in TRUS-Bx

Details and patient eligibility

About

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.

Full 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.

Enrollment

422 patients

Sex

Male

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

422 participants in 2 patient groups

intrarectal lidocaine gel
Experimental group
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
Treatment:
Drug: intrarectal lidocaine gel
periprostatic nerve blockade
Experimental group
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.
Treatment:
Drug: periprostatic nerve blockade

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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