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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Transrectal Systematic Prostate Biopsy Related Pain

Intervention / Treatment
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* Procedure: Pelvic plexus block
* Procedure: Periprostatic nerve block


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pelvic plexus block<br>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<br>* 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<br>|
| Active Comparator: Periprostatic nerve block<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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local anesthesia, prostate, biopsy, transrectal