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

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.

Study Overview

• Status: Unknown
• Conditions: Transrectal Systematic Prostate Biopsy Related Pain
• Intervention / Treatment: Procedure: Pelvic plexus block; Procedure: Periprostatic nerve block

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 Type: Interventional
• Enrollment (Anticipated): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Yonsei University Medical College Gangnam Severance Hospital
    • Contact: KangSu Cho, MD., Ph.D.; Phone Number: +82220193470; Email: kscho99@yuhs.ac
    • Contact: DoKyung Kim, MD.; Phone Number: +821088956433; Email: dokyung@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Procedure: 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
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Complication	Complications after biopsy	day 14~28
Procedure time	Total time taken for prostate biopsy	day 7~14

Collaborators and Investigators

• Sponsor: Gangnam Severance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2018
• Primary Completion (Anticipated): March 1, 2019
• Study Completion (Anticipated): April 1, 2019

Study Registration Dates

• First Submitted: September 20, 2018
• First Submitted That Met QC Criteria: September 20, 2018
• First Posted (Actual): September 24, 2018

Study Record Updates

• Last Update Posted (Actual): September 26, 2018
• Last Update Submitted That Met QC Criteria: September 24, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: local anesthesia; transrectal; prostate, biopsy
• Other Study ID Numbers: 3-2018-0211

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No