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Completed

NCT Number: NCT04501055

Anesthesia in PROstate Biopsy Pain Obstruction Study

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai East Hospital, Tongji University School of Medicine

Shanghai, Shanghai Municipality, 200120, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;

Exclusion criteria

  • 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;

Treatment and study plan

perineal nerve block

Behavioral

An anesthesia method to block perineal nerve

periprostatic block

Behavioral

An anesthesia method to block periprostate

Primary outcomes

  1. The pain of the biopsy procedure

    Time frame: within10 minutes after the prostate biopsy

    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.

Secondary outcomes

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

    Time frame: 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.

  2. Changes in blood pressure during biopsy procedure

    Time frame: During the biopsy procedure

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

  3. Changes in heart rate during biopsy procedure

    Time frame: During the biopsy procedure

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

  4. Changes in breath rate during biopsy procedure

    Time frame: During the biopsy procedure

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

  5. The detection rate for prostate cancer

    Time frame: within 1 month after the biopsy

    The detection rate for any of the prostate cancer

  6. The detection rate for clinically significant prostate cancer

    Time frame: within 1 month after the biopsy

    The detection rate for prostate cancer with a ISUP>2

  7. External manifestation of pain

    Time frame: 10 minutes within biopsy

    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).

  8. Anaesthesia satisfaction

    Time frame: 24 hours after the biopsy

    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).

  9. Adverse event

    Time frame: Within 1 week after the biopsy

    Any of the adverse events during the trial

  10. The number of biopsy cores

    Time frame: 10 minutes within biopsy

    The number of biopsy cores

  11. The location of each biopsy core

    Time frame: 10 minutes within biopsy

    The location of each biopsy core

  12. Prostate volume

    Time frame: within 3 months before the biopsy procedure

    The prostate volume will be measured by MRI before biopsy

Sponsors and collaborators

Lead sponsor

Shanghai East Hospital

Other

Collaborators

  • Chinese University of Hong Kong
  • Chongqing Medical University
  • Guang'an people's hospital of Sichuan province
  • People's Hospital of Yiyuan County
  • Shi Shi Municipal General Hospital
  • The First Affiliated Hospital of University of Science and Technology of China

Registry information

Official study 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

Acronym: APROPOS

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 6, 2020
Registry last updated
Oct 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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