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

What is the Most Effective Local Anesthesia for Prostate-stained Ultrasonography-guided Biopsy in PPB and PNB?: A Single Center, Prospective, Randomized, Double Arm Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03681522
Enrollment
58
Registered
2018-09-24
Start date
2018-09-10
Completion date
2019-04-30
Last updated
2018-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transrectal Systematic Prostate Biopsy Related Pain

Keywords

local anesthesia, prostate, biopsy, transrectal

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.

Interventions

PROCEDUREPelvic 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

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.

Sponsors

Gangnam Severance Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Rate of Complicationday 14~28Complications after biopsy
Procedure timeday 7~14Total time taken for prostate biopsy

Countries

South Korea

Contacts

Primary ContactKangSu Cho, MD., PhD.
kscho99@yuhs.ac+8220193470

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026