Open randomized clinical trial to examine individual pain tolerance in the use of two anesthetic techniques to perform extended prostate biopsy .

Open randomized clinical trial to examine individual pain tolerance in the use of two anesthetic techniques to perform saturation prostate biopsy . - URO ? CHUAC ? BPSat ? 001.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-003740-39-ES

Enrollment

100

Registered

2016-02-24

Start date

2016-04-12

Completion date

Unknown

Last updated

2025-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate biopsy anesthesia MedDRA version: 18.1 Level: LLT Classification code 10004825 Term: Biopsy of prostate System Organ Class: 100000004848

Interventions

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Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: -Male patient -Persistence of suspected prostate cancer by altering the prostatic specific antigen and / or digital rectal examination. -Two previous negative prostate biopsies . -Age =65 years) yes F.1.3.1 Number of subjects for this age range 70

Exclusion criteria

Exclusion criteria: -Age > 75 years. -Absence of consent or refusal to the study . -Presence of prostate cancer in previous biopsy observation . -Medical-surgical patient's problems, absolutely contraindicating biopsy under local anesthesia. -Presence of any allergies to medications involved in the study . -Patient's clinical situation that does not allow an outpatient operation and aftercare required . -Medical condition of the patient, preventing the realization of outpatient biopsy. -No companion.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the effectiveness of two anesthetic techniques by measuring the pain through visual analog scale (VAS ), to obtain saturation prostate biopsies .;Secondary Objective: To assess the safety of the procedure and complications in the use of each of the anesthetic techniques during saturation prostate biopsy;Primary end point(s): To determinate a difference in pain of 1.4 ± 2.5 on the visual analog scale (pain under sedation 0.5 vs. 1.9 with locoregional), with 80 % power and 95 % confidence .;Timepoint(s) of evaluation of this end point: Basal time: Pain at baseline , before any anesthetic procedure or urological manipulation. Scale of 0-10 . End time: Pain after the procedure, the patient leaving the operating room. Scale of 0-10 .	—

Measure

Time frame

Main Objective: To assess the effectiveness of two anesthetic techniques by measuring the pain through visual analog scale (VAS ), to obtain saturation prostate biopsies .;Secondary Objective: To assess the safety of the procedure and complications in the use of each of the anesthetic techniques during saturation prostate biopsy;Primary end point(s): To determinate a difference in pain of 1.4 ± 2.5 on the visual analog scale (pain under sedation 0.5 vs. 1.9 with locoregional), with 80 % power and 95 % confidence .;Timepoint(s) of evaluation of this end point: Basal time: Pain at baseline , before any anesthetic procedure or urological manipulation. Scale of 0-10 . End time: Pain after the procedure, the patient leaving the operating room. Scale of 0-10 .

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Secondary

Measure	Time frame
Secondary end point(s): - Presence of medication side effects of the procedure : nausea or vomiting , hypotension or hypertension and / or bradycardia or tachycardia . - Presence of secondary complications to the procedure : hematuria , urinary difficulty, urinary retention, urinary tract infection and / or sepsis . The use of additional pain medication in the post- procedure is also measured.;Timepoint(s) of evaluation of this end point: Time interval between final procedure and 24 hours after the procedure.	—

Measure

Time frame

Secondary end point(s): - Presence of medication side effects of the procedure : nausea or vomiting , hypotension or hypertension and / or bradycardia or tachycardia . - Presence of secondary complications to the procedure : hematuria , urinary difficulty, urinary retention, urinary tract infection and / or sepsis . The use of additional pain medication in the post- procedure is also measured.;Timepoint(s) of evaluation of this end point: Time interval between final procedure and 24 hours after the procedure.

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Countries

Spain

Contacts

Public ContactJose Luis Ponce Díaz-Reixa

Jose Luis Ponce Díaz-Reixa

Jose.Luis.Ponce.Diaz-Reixa@sergas.es34981178057

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026