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

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

Sponsors

Lead sponsor: Gangnam Severance Hospital

Source 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.

Overall Status Recruiting
Start Date September 10, 2018
Completion Date April 2019
Primary Completion Date March 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Visual analog scale-1 day 7~14
Visual analog scale-2 day 7~14
Visual analog scale-3 day 7~14
Visual analog scale-4 day 7~14
Secondary Outcome
Measure Time Frame
Rate of Complication day 14~28
Procedure time day 7~14
Enrollment 58
Condition
Intervention

Intervention type: Procedure

Intervention name: Pelvic plexus block

Description: 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

Arm group label: Pelvic plexus block

Intervention type: Procedure

Intervention name: Periprostatic nerve block

Description: 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.

Arm group label: Periprostatic nerve block

Eligibility

Criteria:

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

Gender: Male

Minimum age: 50 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Overall Contact

Last name: KangSu Cho, MD., PhD.

Phone: +8220193470

Email: [email protected]

Location
facility status contact contact_backup Yonsei University Medical College Gangnam Severance Hospital KangSu Cho, MD., Ph.D. +82220193470 [email protected]
Location Countries

Korea, Republic of

Verification Date

September 2018

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Gangnam Severance Hospital

Investigator full name: Kang Su Cho

Investigator title: associate professor

Keywords
Has Expanded Access No
Number Of Arms 2
Arm Group

Arm group label: Pelvic plexus block

Arm group type: Experimental

Description: 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

Arm group label: Periprostatic nerve block

Arm group type: Active Comparator

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

Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Triple (Participant, Care Provider, Outcomes Assessor)

Source: ClinicalTrials.gov