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AzTrials

Prostate CancerAPROPOSNCT04501055

Anesthesia in PROstate Biopsy Pain Obstruction Study

A study testing perineal nerve block and periprostatic block in people with Prostate Cancer, run by Shanghai East Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a multicentre randomized controlled trial in comparison of the perineal nerve block approach between the periprostatic block in the pain control in men undergo a transperineal prostate biopsy. Read more about this study

Who is it for?
Ages 18 to 80 years, men onlyHealthy volunteers can take part
Conditions the study is for
Prostate Cancer
What is being tested?
perineal nerve block and periprostatic block
Could I receive a placebo?
No, everyone receives an active treatment
How many people
192 participants
Where
1 siteChina
Study dates
13 Aug 2020to 27 Jul 2022
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 18 to 80 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • age between 18 and 80 years old
  • a PSA level of 4 - 20 ng/ml, and/or suspicious rectal examination findings;
  • fully understand the clinical trial protocol and sign the informed consent;

Who cannot join

  • local anesthetic allergy patients;
  • symptomatic acute or chronic inflammation of the prostate;
  • cannot tolerate prostate biopsy or has contraindication to biopsy;
  • patients judged by the investigator to be unsuitable to participate in the clinical trial;

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai East Hospital, Tongji University School of Medicine

    Shanghai, Shanghai Municipality, 200120

Other trials in China

About this study

Official title: A Prospective Multicenter Randomized Controlled Trial Assessing Whether the Perineal Nerve Block Approach is Better Than the Periprostatic Block for the Pain Control in Men Who Undergo Transperineal Prostate Biopsy

This is a multicentre randomized controlled trial in comparison of the perineal nerve block approach between the periprostatic block in the pain control in men undergo a transperineal prostate biopsy.

Read the detailed description

This trial is a prospective, multicentre, randomized controlled study in which all men plan to undergo a transperineal prostate biopsy. This study aims to determine whether the perineal nerve block approach is better than the periprostatic block in the pain control in men undergo a transperineal prostate biopsy.

Conditions
Prostate Cancer
Being tested
perineal nerve block, periprostatic block
Keywords
Prostate Cancer, transperineal prostate biopsy, perineal nerve block, periprostatic block, anesthesia
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • perineal nerve blockBehavioural

    An anesthesia method to block perineal nerve

  • periprostatic blockBehavioural

    An anesthesia method to block periprostate

Study groups in NCT04501055
Study groupRoleWhat they receive
Perineal nerve blockExperimentalMan receive the perineal nerve block before under the transperineal prostate biopsy
Receives: Behavioral: perineal nerve block
Periprostatic blockActive comparatorMan receive the periprostatic block before under the transperineal prostate biopsy
Receives: Behavioral: periprostatic block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The pain of the biopsy procedure

    The pain will be measured by numerical rating scale（NRS), which distributed from 0 to 10. 0 represents no pain, and 10 represents the worst pain imaginable.

    Measured: within10 minutes after the prostate biopsy

Secondary outcomes (12)

  1. The pain in 1,6, and 12 hours after the biopsy

    The pain in 1,6, and 12 hours will be measured by numerical rating scale（NRS), which distributed from 0 to 10. 0 represents no pain, and 10 represents the worst pain imaginable.

    Measured: 1,6, and 12 hours after the biopsy

  2. Changes in blood pressure during biopsy procedure

    The changes will be measured and recorded by multi-parameter monitoring

    Measured: During the biopsy procedure

  3. Changes in heart rate during biopsy procedure

    The changes will be measured and recorded by multi-parameter monitoring

    Measured: During the biopsy procedure

  4. Changes in breath rate during biopsy procedure

    The changes will be measured and recorded by multi-parameter monitoring

    Measured: During the biopsy procedure

  5. The detection rate for prostate cancer

    The detection rate for any of the prostate cancer

    Measured: within 1 month after the biopsy

  6. The detection rate for clinically significant prostate cancer

    The detection rate for prostate cancer with a ISUP>2

    Measured: within 1 month after the biopsy

  7. External manifestation of pain

    A questionnaire with five items: the degree of facial expression (0 for no particular expression or smile; 1 for an occasional grimace or frown, a withdrawn expression, or a disinterested expression; 2 for frequent or constant quivering chin or a clenched jaw), the degree of activity (0 for lying quietly or being in a normal position, 1 for slight contractions of the hip muscles or slight movements of hip, 2 for severe contractions of the hip or lifting the hip out of the bed), the degree of voice expression (0 for quiet or normal communication, 1 for an occasional moan or weeping sound, 2 for constant moaning or sobbing and screaming), the degree of pacification (0 for being peaceful and not requiring pacification, 1 for being able to be comforted easily, 2 for being difficult to comfort) and the degree of cooperation (0 for being calm and cooperative, 1 for language resistance, 2 for body resistance).

    Measured: 10 minutes within biopsy

  8. Anaesthesia satisfaction

    A questionnaire with five items :whether the pain during the biopsy was less severe than expected (scores from 0 to 10, where 0 represents far less severe and 10 represents far more severe than expected); whether the pain after anaesthesia was less severe than the pain during anaesthesia (scores from 0 to 10, where 0 represents far less severe and 10 represents far more severe); weather the patient is satisfied with the overall feeling of the biopsy (scores from 0 to 10, where 0 represents the highest level of satisfaction and 10 represents the lowest level of satisfaction); whether the patient would recommend this type of biopsy to other patients (scores from 0 to 10, where 0 represents they would highly recommend it and 10 represents they would definitely not recommend it); and whether the patient would still want to choose this way if they have to undergo another biopsy (scores from 0 to 10, where 0 represents very willing to choose it and 10 represents extreme reluctance).

    Measured: 24 hours after the biopsy

  9. Adverse event

    Any of the adverse events during the trial

    Measured: Within 1 week after the biopsy

  10. The number of biopsy cores

    The number of biopsy cores

    Measured: 10 minutes within biopsy

  11. The location of each biopsy core

    The location of each biopsy core

    Measured: 10 minutes within biopsy

  12. Prostate volume

    The prostate volume will be measured by MRI before biopsy

    Measured: within 3 months before the biopsy procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2020
  2. Study start13 Aug 2020
  3. Primary completion20 Jul 2022
  4. Study completion27 Jul 2022

Resources

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, Investigator, Outcomes assessor
Enrolment
192 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04501055
Sponsor's protocol ID
APROPOS-01
Acronym
APROPOS
Status last verified
Oct 2022
First submitted
29 Jul 2020
Last updated
28 Oct 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Once available, the results of this trial will be disseminated to an international peer-reviewed journal and presentations at international or national academic conferences. The data will be made available upon request to researchers a) who provide a methodologically sound proposal and b) whose proposed use of the data has been approved by an independent ethical review committee.

Publications

  • He BM, Ka-Fung Chiu P, Tao T, Lan JH, Cai JT, Zhou SC, Li RB, Ren Y, Ka-Lun LO, Xu RY, Chen JR, Lan D, Gao JL, Chu SG, Jin ZC, Huang FF, Shi ZK, Yang QW, Zhou H, Wang SD, Ji TR, Han QP, Wang CM, Chi-Fai NG, Wang HF; APROPOS Group. Perineal nerve block versus periprostatic block for patients undergoing transperineal prostate biopsy (APROPOS): a prospective, multicentre, randomised controlled study. EClinicalMedicine. 2023 Mar 23;58:101919. doi: 10.1016/j.eclinm.2023.101919. eCollection 2023 Apr.

    PubMed 37007736

  • He BM, Li RB, Wang HF. Anaesthesia in PROstate Biopsy Pain Obstruction Study: A Study Protocol for a Multicentre Randomised Controlled Study Evaluating the Efficacy of Perineal Nerve Block in Controlling Pain in Patients Undergoing Transperineal Prostate Biopsy. Front Surg. 2021 Oct 6;8:649822. doi: 10.3389/fsurg.2021.649822. eCollection 2021.

    PubMed 34692757

Questions about this trial

What is this clinical trial studying?

A study testing perineal nerve block and periprostatic block in people with Prostate Cancer, run by Shanghai East Hospital 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 3 inclusion and 4 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 28 Oct 2022. 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?

The pain of the biopsy procedure (time frame: within10 minutes after the prostate biopsy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04501055, which also lists 2 linked publications.

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 28 Oct 2022.

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Anesthesia in PROstate Biopsy Pain Obstruction Study | AzTrials