Prostate BiopsyNCT03500432
A Study of a New Local Anesthesia Method for Transperineal Prostate Biopsy
A study testing local anesthesia of trnasperineal prostate biopsy in people with Prostate Biopsy and Local Anesthesia, run by Second Military Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 90 years, men only
- Conditions the study is for
- Prostate Biopsy, Local Anesthesia
- What is being tested?
- local anesthesia of trnasperineal prostate biopsy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 2 Feb 2018to 22 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Changhai Hospital,Second Military Medical University
Shanghai, Shanghai Municipality, 200000
About this study
Official title: 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.
Read the 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.
- Conditions
- Prostate Biopsy, Local Anesthesia
- Being tested
- local anesthesia of trnasperineal prostate biopsy
- Keywords
- transperineal prostate biopsy, local anesthesia, prostate cancer diagnosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
local anesthesia of trnasperineal prostate biopsyProcedure or surgery
Also called lidocaine, long injection needles
three different block site with lidocaine
| Study group | Role | What they receive |
|---|---|---|
| periprostatic group | Active comparator | local anesthesia of trnasperineal prostate biopsy with subcutaneous local anesthesia+periprostatic block Receives: 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 Receives: 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 Receives: Procedure: local anesthesia of trnasperineal prostate biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: ask patients in 2 minutes after prostate biopsy
Secondary outcomes (3)
Complications
Complications associated with local anesthesia. The complication include: bleeding, intoxation of local anesthetic and anaphylaxis of local anesthetic.
Measured: 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.
Measured: 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.
Measured: during the transperineal prostate biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start2 Feb 2018
- Primary completion22 Mar 2018
- Study completion22 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate BiopsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Second Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yinghao Sun, Second Military Medical University
- Investigators
- Yinghao 2 Sun, professor, Study chair, Second Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03500432
- Sponsor's protocol ID
- SP-FA2018001
- Status last verified
- Apr 2018
- First submitted
- 21 Mar 2018
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel, Repeatable, and Effective Local Anesthesia Method for Transperineal Prostate biopsy-a Single Center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03500432
- Acronym / sponsor ID
- SP-FA2018001
- Conditions
- Prostate Biopsy, Local Anesthesia
- Keywords
- transperineal prostate biopsy, local anesthesia, prostate cancer diagnosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Second Military Medical UniversityUniversity, hospital or other
- Study start
- 2 Feb 2018 (actual)
- Primary completion
- 22 Mar 2018 (actual)
- Study completion
- 22 Mar 2018 (actual)
- First posted
- 18 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| periprostatic group | Active comparator | Procedure: local anesthesia of trnasperineal prostate biopsylocal anesthesia of trnasperineal prostate biopsy with subcutaneous local anesthesia+periprostatic block |
| PAT group | Active comparator | Procedure: local anesthesia of trnasperineal prostate biopsylocal anesthesia of trnasperineal prostate biopsy with subcutaneous local anesthesia+periapical triangle (PAT) block |
| TPA switch group | Experimental | Procedure: local anesthesia of trnasperineal prostate biopsylocal anesthesia of trnasperineal prostate biopsy with subcutaneous local anesthesia+TPA switch (transperineal prostate biopsy local anesthesia switch) block |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| local anesthesia of trnasperineal prostate biopsyAlso: lidocaine, long injection needlesthree different block site with lidocaine | Procedure or surgery | PAT group, TPA switch group, periprostatic group |
Primary outcome
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.
3 secondary outcomes
Complications
Time frame: during the procedures and 1 days after the procedure
main VAS scores
Time frame: ask patients in 2 minutes after prostate biopsy
patients movement
Time frame: during the transperineal prostate biopsy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yinghao 2 Sun, professor study chair
Second Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing local anesthesia of trnasperineal prostate biopsy in people with Prostate Biopsy and Local Anesthesia, run by Second Military Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
highest VAS scores (time frame: ask patients in 2 minutes after prostate biopsy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2018.