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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-10

Study Completion Date

2019-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Transrectal Systematic Prostate Biopsy Related Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Pelvic plexus block

Intervention Type PROCEDURE

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

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.

Group Type ACTIVE_COMPARATOR

Periprostatic nerve block

Intervention Type PROCEDURE

Injections of 2.5 mL of 2% lidocaine were made to the neurovascular bundles at the junction of the prostate-bladder-seminal vesicle on each side.

Interventions

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Pelvic plexus block

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

Intervention Type PROCEDURE

Periprostatic nerve block

Injections of 2.5 mL of 2% lidocaine were made to the neurovascular bundles at the junction of the prostate-bladder-seminal vesicle on each side.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes