Transrectal Systematic Prostate Biopsy Related PainNCT03681522
A Study on the Pain Control Effect of the Anesthetic Method During Prostate Biopsy: Comparison Between Pelvic Plexus Block and Periprosthetic Nerve Block
A study testing Pelvic plexus block and Periprostatic nerve block in people with Transrectal Systematic Prostate Biopsy Related Pain, run by Gangnam Severance Hospital at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Transrectal Systematic Prostate Biopsy Related Pain
- What is being tested?
- Pelvic plexus block and Periprostatic nerve block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Sep 2018to Apr 2019
- 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 50 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- abnormal prostate finding on digital rectal examination
- serum PSA level of > 2.5 ng/mL
- Transrectal ultrasonographic abnormal lesion
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei University Medical College Gangnam Severance Hospital
Seoul
KangSu Cho, MD., Ph.D., +82220193470, kscho99@yuhs.ac
DoKyung Kim, MD., +821088956433, dokyung@yuhs.ac
About this study
Official title: 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
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.
Read the detailed description
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.
- Being tested
- Pelvic plexus block, Periprostatic nerve block
- Keywords
- local anesthesia, prostate, biopsy, transrectal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic plexus blockProcedure or surgery
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
Periprostatic nerve blockProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Pelvic plexus block | Experimental | 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 Receives: Procedure: Pelvic plexus block |
| Periprostatic nerve block | Active comparator | The injections of 2.5 mL of 2% lidocaine were made to the neurovascular bundles at the junction of the prostate-bladder-seminal vesicle. Receives: Procedure: Periprostatic nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale-1
Visual analog scale (0-10) during anesthesia procedure higher values represent a worse outcome.
Measured: day 7~14
Visual analog scale-2
Visual analog scale (0-10) at insertion of ultrasound probe higher values represent a worse outcome.
Measured: day 7~14
Visual analog scale-3
Visual analog scale (0-10) during biopsy procedure higher values represent a worse outcome.
Measured: 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.
Measured: day 7~14
Secondary outcomes (2)
Rate of Complication
Complications after biopsy
Measured: day 14~28
Procedure time
Total time taken for prostate biopsy
Measured: day 7~14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2018
- Study start10 Sep 2018
- Primary completionMar 2019 (estimated)
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transrectal Systematic Prostate Biopsy Related PainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kang Su Cho, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03681522
- Sponsor's protocol ID
- 3-2018-0211
- Status last verified
- Sep 2018
- First submitted
- 20 Sep 2018
- Last updated
- 26 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03681522
- Acronym / sponsor ID
- 3-2018-0211
- Keywords
- local anesthesia, prostate, biopsy, transrectal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 10 Sep 2018 (actual)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 24 Sep 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.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pelvic plexus block | Experimental | Procedure: Pelvic plexus blockThe 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 |
| Periprostatic nerve block | Active comparator | Procedure: Periprostatic nerve blockThe injections of 2.5 mL of 2% lidocaine were made to the neurovascular bundles at the junction of the prostate-bladder-seminal vesicle. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- abnormal prostate finding on digital rectal examination
- serum PSA level of > 2.5 ng/mL
- Transrectal ultrasonographic abnormal lesion
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Pelvic plexus blockInjections 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 or surgery | Pelvic plexus block |
| Periprostatic nerve blockInjections 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. | Procedure or surgery | Periprostatic nerve block |
Primary outcome
Visual analog scale-1
Time frame: day 7~14
Visual analog scale (0-10) during anesthesia procedure higher values represent a worse outcome.
Visual analog scale-2
Time frame: day 7~14
Visual analog scale (0-10) at insertion of ultrasound probe higher values represent a worse outcome.
Visual analog scale-3
Time frame: day 7~14
Visual analog scale (0-10) during biopsy procedure higher values represent a worse outcome.
Visual analog scale-4
Time frame: day 7~14
Visual analog scale (0-10) at 15 min after the biopsy procedure higher values represent a worse outcome.
2 secondary outcomes
Rate of Complication
Time frame: day 14~28
Procedure time
Time frame: day 7~14
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2018.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic plexus block and Periprostatic nerve block in people with Transrectal Systematic Prostate Biopsy Related Pain, run by Gangnam Severance Hospital at 1 site in South Korea.
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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 26 Sep 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact KangSu Cho, MD., PhD. (+8220193470, kscho99@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale-1 (time frame: day 7~14). The study lists 4 primary outcomes in all. 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 26 Sep 2018.