A Study of a New Local Anesthesia Method for Transperineal Prostate Biopsy

NCT03500432 | Completed

• 1 other identifier: SP-FA2018001
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Biopsy; Local Anesthesia

Keywords

transperineal prostate biopsy; local anesthesia; prostate cancer diagnosis

Outcome Measures

Primary Outcomes (1)

• highest VAS scores

  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.

  ask patients in 2 minutes after prostate biopsy

Secondary Outcomes (3)

• Complications

  during the procedures and 1 days after the procedure

• main VAS scores

  ask patients in 2 minutes after prostate biopsy

• patients movement

  during the transperineal prostate biopsy

Study Arms (3)

periprostatic group

ACTIVE COMPARATOR

local anesthesia of trnasperineal prostate biopsy with subcutaneous local anesthesia+periprostatic block

Procedure: local anesthesia of trnasperineal prostate biopsy

PAT group

ACTIVE COMPARATOR

local anesthesia of trnasperineal prostate biopsy with subcutaneous local anesthesia+periapical triangle (PAT) block

Procedure: local anesthesia of trnasperineal prostate biopsy

TPA switch group

EXPERIMENTAL

local anesthesia of trnasperineal prostate biopsy with subcutaneous local anesthesia+TPA switch (transperineal prostate biopsy local anesthesia switch) block

Procedure: local anesthesia of trnasperineal prostate biopsy

Interventions

local anesthesia of trnasperineal prostate biopsy PROCEDURE

three different block site with lidocaine

Also known as: lidocaine, long injection needles

PAT group; TPA switch group; periprostatic group

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. ready to be performed transperineal prostate biopsy; 2. fully understand the protocol and aggree to undergo prostate biopsy with local anesthesia which might be elder methods or new experimental method.

You may not qualify if:

• do not have the history of anaphylaxis or local anesthetic intoxation； 2. cardiac dysfunction or coagulation dysfunction; 3. Rectal disease which can not allowed to plug the ultrasound probe in; 4.do not fully understand our protocol; 5. do not aggree our protocol.

Sponsors & Collaborators

• Second Military Medical University: lead

Study Sites (1)

Changhai Hospital,Second Military Medical University

Shanghai, Shanghai Municipality, 200000, China

Location

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Yinghao 2 Sun, professor

  Second Military Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 21, 2018
• First Posted: April 18, 2018
• Study Start: February 2, 2018
• Primary Completion: March 22, 2018
• Study Completion: March 22, 2018
• Last Updated: April 18, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)