NCT03681522

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 10, 2018

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 20, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 24, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

September 26, 2018

Status Verified

September 1, 2018

Enrollment Period

6 months

First QC Date

September 20, 2018

Last Update Submit

September 24, 2018

Conditions

Transrectal Systematic Prostate Biopsy Related Pain

Keywords

local anesthesiaprostate, biopsytransrectal

Outcome Measures

Primary Outcomes (4)

  • Visual analog scale-1

    Visual analog scale (0-10) during anesthesia procedure higher values represent a worse outcome.

    day 7~14

  • Visual analog scale-2

    Visual analog scale (0-10) at insertion of ultrasound probe higher values represent a worse outcome.

    day 7~14

  • Visual analog scale-3

    Visual analog scale (0-10) during biopsy procedure higher values represent a worse outcome.

    day 7~14

  • Visual analog scale-4

    Visual analog scale (0-10) at 15 min after the biopsy procedure higher values represent a worse outcome.

    day 7~14

Secondary Outcomes (2)

  • Rate of Complication

    day 14~28

  • Procedure time

    day 7~14

Study Arms (2)

Pelvic plexus block

EXPERIMENTAL

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

Procedure: Pelvic plexus block

Periprostatic nerve block

ACTIVE COMPARATOR

The injections of 2.5 mL of 2% lidocaine were made to the neurovascular bundles at the junction of the prostate-bladder-seminal vesicle.

Procedure: Periprostatic nerve block

Interventions

Pelvic plexus blockPROCEDURE

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

Pelvic plexus block
Periprostatic nerve blockPROCEDURE

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.

Periprostatic nerve block

Eligibility Criteria

Age50 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yonsei University Medical College Gangnam Severance Hospital

Seoul, South Korea

RECRUITING

Central Study Contacts

KangSu Cho, MD., PhD.

CONTACT

+8220193470kscho99@yuhs.ac

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

September 20, 2018

First Posted

September 24, 2018

Study Start

September 10, 2018

Primary Completion

March 1, 2019

Study Completion

April 1, 2019

Last Updated

September 26, 2018

Record last verified: 2018-09

Locations

KR(1)