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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

Y

Yonsei University Health System (YUHS)

Status

Unknown

Conditions

Transrectal Systematic Prostate Biopsy Related Pain

Treatments

Procedure: Pelvic plexus block
Procedure: Periprostatic nerve block

Study type

Interventional

Funder types

Other

Identifiers

NCT03681522
3-2018-0211

Details and patient eligibility

About

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.

Full 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.

Enrollment

58 estimated patients

Sex

Male

Ages

50+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

58 participants in 2 patient groups

Pelvic plexus block
Experimental group
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
Treatment:
Procedure: Pelvic plexus block
Periprostatic nerve block
Active Comparator group
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.
Treatment:
Procedure: Periprostatic nerve block

Trial contacts and locations

1

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Central trial contact

KangSu Cho, MD., PhD.

Data sourced from clinicaltrials.gov

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