Clinical Trial to Examine Individual Pain Tolerance in the Use of Two Anesthetic Techniques to Perform Saturation Prostate Biopsy
NCT ID: NCT02909049
Last Updated: 2018-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
100 participants
INTERVENTIONAL
2016-04-30
2018-01-24
Brief Summary
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Detailed Description
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Anesthetic technique (control) - Intravenous sedation with Midazolam, Fentanile and Ketamine.
Anesthetic technique (intervention) - Regional Mepivacaine infiltration of periprostatic region.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CONTROL
Saturation prostate biopsy under intravenous sedation MIDAZOLAM 1,5 mg per kilogram intravenous, 5 minutes prior to biopsy FENTANILE 0,05 mg per kilogram intravenous, 3 minutes prior to biopsy KETAMINE 0.5 mg per kilogram intravenous, 1 minute prior to biopsy
MIDAZOLAM
Intravenous bolus anesthesia 5 minutes previous to saturation prostate biopsy.
FENTANILE
Intravenous bolus anesthesia 3 minutes previous to saturation prostate biopsy.
KETAMINE
Intravenous bolus anesthesia 1 minute previous to saturation prostate biopsy.
EXPERIMENTAL
Saturation prostate biopsy under local anesthesia MEPIVACAÍNE 2% 10 millimeters periprostatic block at base and ápex, bilaterally.
MEPIVACAÍNE
Local periprostatic anesthesia infiltration, previous to saturation prostate biopsy.
Interventions
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MIDAZOLAM
Intravenous bolus anesthesia 5 minutes previous to saturation prostate biopsy.
MEPIVACAÍNE
Local periprostatic anesthesia infiltration, previous to saturation prostate biopsy.
FENTANILE
Intravenous bolus anesthesia 3 minutes previous to saturation prostate biopsy.
KETAMINE
Intravenous bolus anesthesia 1 minute previous to saturation prostate biopsy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
MALE
No
Sponsors
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Complexo Hospitalario Universitario de A Coruña
OTHER
Responsible Party
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José Luis Ponce Díaz-Reixa
MD
Principal Investigators
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Jose L Ponce, MD
Role: PRINCIPAL_INVESTIGATOR
Complejo Hospitalario Universitario, A Coruña
Locations
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Jose Luis Ponce Diaz-Reixa
A Coruña, , Spain
Countries
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Other Identifiers
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URO - CHUAC - BPSat - 001.
Identifier Type: -
Identifier Source: org_study_id
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