Clinical Trial to Examine Individual Pain Tolerance in the Use of Two Anesthetic Techniques to Perform Saturation Prostate Biopsy

Open Randomized Clinical Trial to Examine Individual Pain Tolerance in the Use of Two Anesthetic Techniques to Perform Saturation Prostate Biopsy

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02909049

Enrollment

100

Registered

2016-09-21

Start date

2016-04-30

Completion date

2018-01-24

Last updated

2018-01-26

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

Conditions

Prostatic Cancer

Keywords

Prostate Biopsy, Local Anesthesia, Pain, Biopsy of prostate

Brief summary

To assess the effectiveness of two anesthetic techniques by measuring the pain through visual analog scale (VAS), to obtain saturation prostate biopsies.

Detailed description

To assess the effectiveness of two anesthetic techniques by measuring the pain through visual analog scale (VAS), to obtain saturation prostate biopsies. Anesthetic technique (control) - Intravenous sedation with Midazolam, Fentanile and Ketamine. Anesthetic technique (intervention) - Regional Mepivacaine infiltration of periprostatic region.

Interventions

DRUGMIDAZOLAM

Intravenous bolus anesthesia 5 minutes previous to saturation prostate biopsy.

DRUGMEPIVACAÍNE

Local periprostatic anesthesia infiltration, previous to saturation prostate biopsy.

DRUGFENTANILE

Intravenous bolus anesthesia 3 minutes previous to saturation prostate biopsy.

DRUGKETAMINE

Intravenous bolus anesthesia 1 minute previous to saturation prostate biopsy.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 75 Years

Healthy volunteers

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 \< 75 years. * Signature of informed consent to perform prostate biopsy. * Signature of informed consent for the study.

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	Description
Change in visual analog scale (VAS)	1 hour baseline	Change in visual analog scale (VAS) from baseline and after prostate biopsy

Secondary

Measure	Time frame	Description
Number of patients with complications after anesthesic procedure and prostate biopsy procedure, after 24 hours of the procedure and at end of study visit. All units will be measured as numbers.	One week	To assess the safety of the procedure and complications in the use of each of the anesthetic techniques during saturation prostate biopsy. Safety events will be measured during saturation prostate biopsy and after recovery, during 24 hours. Number of patients with complications after anesthesic procedure and prostate biopsy procedure. Number of patients with complications after 24 hours of the procedure. Number of patients with complications at end of study visit.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026