A Study on the Pain Control Effect of the Anesthetic Method During Prostate Biopsy: Comparison Between Pelvic Plexus Block and Periprosthetic Nerve Block

Not Applicable

• Conditions: Transrectal Systematic Prostate Biopsy Related Pain
• Interventions: Procedure: Periprostatic nerve block; Procedure: Pelvic plexus block

• Registration Number: NCT03681522
• Lead Sponsor: Gangnam Severance Hospital

Brief Summary

This study assesses differences in the effects of pelvic plexus block and periprostatic nerve block among various anesthetic methods that reduce the pain caused by prostate biopsy.

Detailed Description

Recently, various types of local anesthetic methods have been attempted to reduce biopsy-related pain leading to changes in the type of anesthetic agents and site of injection. Of these anesthetics and combinations, pelvic plexus block and periprostatic nerve block seem to be the very effective way to control prostate biopsy-related pain. However, few studies have compared these two methods.

Study Timeline

• Status Verified: 2018-09
• Study Start: 2018-09-10
• Study First Submitted: 2018-09-20
• Study First Submitted QC: 2018-09-20
• Study First Posted: 2018-09-24
• Last Update Submitted: 2018-09-24
• Last Update Posted: 2018-09-26
• Primary Completion: 2019-03
• Study Completion: 2019-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 58

Inclusion Criteria

• abnormal prostate finding on digital rectal examination
• serum PSA level of > 2.5 ng/mL
• Transrectal ultrasonographic abnormal lesion

Exclusion Criteria

• under 50 years old
• a history of previous TRUS-guided biopsy
• chronic prostatitis/pelvic pain
• neurological conditions (dementia, Parkinson disease, or cerebral infarction)
• bleeding diathesis
• active UTI
• hemorrhoids/anal fissure/anal fistula
• known allergy to lidocaine

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Periprostatic nerve block	Periprostatic nerve block	The injections of 2.5 mL of 2% lidocaine were made to the neurovascular bundles at the junction of the prostate-bladder-seminal vesicle.
Pelvic plexus block	Pelvic plexus block	The injections of 2.5 mL of 2% lidocaine were made to the pelvic neurovascular plexus located at the end of the seminal vesicle under Doppler US guidance on each side

Primary Outcome Measures

Name	Time	Method
Visual analog scale-1	day 7~14	Visual analog scale (0-10) during anesthesia procedure higher values represent a worse outcome.
Visual analog scale-4	day 7~14	Visual analog scale (0-10) at 15 min after the biopsy procedure higher values represent a worse outcome.
Visual analog scale-2	day 7~14	Visual analog scale (0-10) at insertion of ultrasound probe higher values represent a worse outcome.
Visual analog scale-3	day 7~14	Visual analog scale (0-10) during biopsy procedure higher values represent a worse outcome.

Secondary Outcome Measures

Name	Time	Method
Procedure time	day 7~14	Total time taken for prostate biopsy
Rate of Complication	day 14~28	Complications after biopsy

Trial Locations

Locations (1)

Yonsei University Medical College Gangnam Severance Hospital; 🇰🇷 Seoul, Korea, Republic of