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

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

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.

Study Overview

• Status: Completed
• Conditions: Local Anesthesia; Prostate Biopsy
• Intervention / Treatment: Procedure: local anesthesia of trnasperineal prostate biopsy

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Changhai Hospital,Second Military Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• 1. 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.

Exclusion Criteria:

• 1.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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: periprostatic group; local anesthesia of trnasperineal prostate biopsy with subcutaneous local anesthesia+periprostatic block	Procedure: local anesthesia of trnasperineal prostate biopsy; three different block site with lidocaine; Other Names: lidocaine, long injection needles
Active Comparator: PAT group; local anesthesia of trnasperineal prostate biopsy with subcutaneous local anesthesia+periapical triangle (PAT) block	Procedure: local anesthesia of trnasperineal prostate biopsy; three different block site with lidocaine; Other Names: lidocaine, long injection needles
Experimental: TPA switch group; 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; three different block site with lidocaine; Other Names: lidocaine, long injection needles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	Complications associated with local anesthesia. The complication include: bleeding, intoxation of local anesthetic and anaphylaxis of local anesthetic.	during the procedures and 1 days after the procedure
main VAS scores	the main 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
patients movement	During the procedure if there is movement of the body which will affect the process of prostate biopsy.	during the transperineal prostate biopsy

Collaborators and Investigators

• Sponsor: Second Military Medical University
• Investigators: Study Chair: Yinghao 2 Sun, professor, Second Military Medical University

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2018
• Primary Completion (Actual): March 22, 2018
• Study Completion (Actual): March 22, 2018

Study Registration Dates

• First Submitted: March 21, 2018
• First Submitted That Met QC Criteria: April 14, 2018
• First Posted (Actual): April 18, 2018

Study Record Updates

• Last Update Posted (Actual): April 18, 2018
• Last Update Submitted That Met QC Criteria: April 14, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: local anesthesia; prostate cancer diagnosis; transperineal prostate biopsy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: SP-FA2018001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No