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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

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ClinicalTrials.gov Identifier: NCT03681522
Recruitment Status : Recruiting
First Posted : September 24, 2018
Last Update Posted : September 26, 2018
Sponsor:
Information provided by (Responsible Party):
Kang Su Cho, 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.

Condition or disease Intervention/treatment Phase
Transrectal Systematic Prostate Biopsy Related Pain Procedure: Pelvic plexus block Procedure: Periprostatic nerve block Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 10, 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

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.




Primary Outcome Measures :
  1. Visual analog scale-1 [ Time Frame: day 7~14 ]
    Visual analog scale (0-10) during anesthesia procedure higher values represent a worse outcome.

  2. Visual analog scale-2 [ Time Frame: day 7~14 ]
    Visual analog scale (0-10) at insertion of ultrasound probe higher values represent a worse outcome.

  3. Visual analog scale-3 [ Time Frame: day 7~14 ]
    Visual analog scale (0-10) during biopsy procedure higher values represent a worse outcome.

  4. Visual analog scale-4 [ Time Frame: day 7~14 ]
    Visual analog scale (0-10) at 15 min after the biopsy procedure higher values represent a worse outcome.


Secondary Outcome Measures :
  1. Rate of Complication [ Time Frame: day 14~28 ]
    Complications after biopsy

  2. Procedure time [ Time Frame: day 7~14 ]
    Total time taken for prostate biopsy



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03681522


Contacts
Contact: KangSu Cho, MD., PhD. +8220193470 kscho99@yuhs.ac

Locations
Korea, Republic of
Yonsei University Medical College Gangnam Severance Hospital Recruiting
Seoul, Korea, Republic of
Contact: KangSu Cho, MD., Ph.D.    +82220193470    kscho99@yuhs.ac   
Contact: DoKyung Kim, MD.    +821088956433    dokyung@yuhs.ac   
Sponsors and Collaborators
Gangnam Severance Hospital

Responsible Party: Kang Su Cho, associate professor, Gangnam Severance Hospital
ClinicalTrials.gov Identifier: NCT03681522     History of Changes
Other Study ID Numbers: 3-2018-0211
First Posted: September 24, 2018    Key Record Dates
Last Update Posted: September 26, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kang Su Cho, Gangnam Severance Hospital:
local anesthesia
prostate, biopsy
transrectal

Additional relevant MeSH terms:
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action