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Clinical Trials/NCT03500432
NCT03500432
Completed
Not Applicable

A Novel, Repeatable, and Effective Local Anesthesia Method for Transperineal Prostate biopsy-a Single Center Randomized Controlled Trial

Second Military Medical University1 site in 1 country90 target enrollmentFebruary 2, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prostate Biopsy
Sponsor
Second Military Medical University
Enrollment
90
Locations
1
Primary Endpoint
highest VAS scores
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

In comparison with transrectal prostate biopsy, transperineal prostate biopsy has the advantage of better sampling from the anterior area, low risk of infection, and no rectal bleeding. The main problems associated with the transperineal method are pain control and additional general or spinal anesthesia. Three types of anesthesia have been reported for transperineal prostate biopsy: (1) spinal anesthesia; (2) general anesthesia; and (3) local anesthesia. From the viewpoint of patient selection (general anesthesia is contraindicated in some patients) and medical cost, local anesthesia is the most suitable choice for prostate biopsy. Periprostatic block is the standard method of local anesthesia for this procedure. However, periprostatic block is insufficient for transperineal prostate biopsy due to high pain sensitivity in this region. A number of new methods to eliminate pain have been reported, including (1) periapical triangle (PAT) block, (2) paraprostatic plus sexual nerve block, and (3) periprostatic block plus pudendal block.However, there is no anatomical basis for some of these methods, and there have been no randomized controlled trials to evaluate their effectiveness, and some methods are technically difficult to learn. In the previous perineal nerve autopsy, we found that there are two branches leading into the prostate and anterior lateral prostatic tissue, which is the main site of puncture pain. There is a fixed position where the two branches appear. Therefore, this anatomical position block may be a useful site for local anesthesia. We named this location the 'transperineal prostate biopsy local anesthesia switch' (abbreviated as TPA switch). In order to validate its effect, we organized this clinical trail.

Detailed Description

Ninety patients scheduled for prostate biopsy will include in this study. The clinical trial validation process will be as follows: (1) all patients are randomly divided into three groups (Figure 1): group 1, subcutaneous local anesthesia+periprostatic block; group 2, subcutaneous local anesthesia+periapical triangle (PAT) block; group 3, subcutaneous local anesthesia+TPA switch (transperineal prostate biopsy local anesthesia switch) block; VAS scores for each puncture and complications will be recorded.

Registry
clinicaltrials.gov
Start Date
February 2, 2018
End Date
March 22, 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Sponsor
Second Military Medical University
Responsible Party
Principal Investigator
Principal Investigator

yinghao Sun

Principal Investigator

Second Military Medical University

Eligibility Criteria

Inclusion Criteria

  • ready to be performed transperineal prostate biopsy;
  • fully understand the protocol and aggree to undergo prostate biopsy with local anesthesia which might be elder methods or new experimental method.

Exclusion Criteria

  • 1.do not have the history of anaphylaxis or local anesthetic intoxation;
  • cardiac dysfunction or coagulation dysfunction;
  • Rectal disease which can not allowed to plug the ultrasound probe in; 4.do not fully understand our protocol;
  • do not aggree our protocol.

Outcomes

Primary Outcomes

highest VAS scores

Time Frame: ask patients in 2 minutes after prostate biopsy

the highest VAS (visual analogue scale) scores during the procedure in one patient. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. VAS is the most common pain scale for quantification of endometriosis-related pain and skin graft donor site-related pain. In detail, it is a 10-point categorical scale pain measurement. The score ranges from 0 to 10, and the no pain is 0, and highest pain is 10.

Secondary Outcomes

  • Complications(during the procedures and 1 days after the procedure)
  • patients movement(during the transperineal prostate biopsy)
  • main VAS scores(ask patients in 2 minutes after prostate biopsy)

Study Sites (1)

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