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

• ClinicalTrials.gov Identifier: NCT02909049
• Recruitment Status: Completed
• First Posted: September 21, 2016
• Last Update Posted: January 26, 2018
• Sponsor: Complexo Hospitalario Universitario de A Coruña
• Information provided by (Responsible Party): José Luis Ponce Díaz-Reixa, Complexo Hospitalario Universitario de A Coruña

Tracking Information

• First Submitted Date: April 19, 2016
• First Posted Date: September 21, 2016
• Last Update Posted Date: January 26, 2018
• Study Start Date: April 2016
• Actual Primary Completion Date: January 24, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 23, 2016)

Change in visual analog scale (VAS) [ Time Frame: 1 hour baseline ]

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

Original Primary Outcome Measures (submitted: September 19, 2016)

Change in visual analog scale (VAS) [ Time Frame: 1 hour ]

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

Current Secondary Outcome Measures (submitted: September 19, 2016)

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. [ Time Frame: 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Clinical Trial to Examine Individual Pain Tolerance in the Use of Two Anesthetic Techniques to Perform Saturation Prostate Biopsy
• Official Title: Open Randomized Clinical Trial to Examine Individual Pain Tolerance in the Use of Two Anesthetic Techniques to Perform Saturation Prostate Biopsy
• 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.

• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Prostatic Cancer

Intervention

• Drug: MIDAZOLAM
  Intravenous bolus anesthesia 5 minutes previous to saturation prostate biopsy.
  Other Name: MIDAZOLAM 15mg/3ml ATC N05CD08 MAN 65319
• Drug: MEPIVACAÍNE
  Local periprostatic anesthesia infiltration, previous to saturation prostate biopsy.
  Other Name: MEPIVACAINE 2% ATC N01BB03 MAN 62606
• Drug: FENTANILE
  Intravenous bolus anesthesia 3 minutes previous to saturation prostate biopsy.
  Other Name: FENTANILE 0,05 mg/ml ATC N01AH01 MAN 41764
• Drug: KETAMINE
  Intravenous bolus anesthesia 1 minute previous to saturation prostate biopsy.
  Other Name: KETAMINE 50 mg/ml ATC N01AX03 Marketing Authorisation number 47034

Study Arms

• Active Comparator: 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
  Interventions:

  • Drug: MIDAZOLAM
  • Drug: FENTANILE
  • Drug: KETAMINE
• Experimental: EXPERIMENTAL
  Saturation prostate biopsy under local anesthesia MEPIVACAÍNE 2% 10 millimeters periprostatic block at base and ápex, bilaterally.
  Intervention: Drug: MEPIVACAÍNE

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 19, 2016): 100
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: January 24, 2018
• Actual Primary Completion Date: January 24, 2018 (Final data collection date for primary outcome measure)

Eligibility 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 < 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.

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT02909049
• Other Study ID Numbers: URO - CHUAC - BPSat - 001.
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: José Luis Ponce Díaz-Reixa, Complexo Hospitalario Universitario de A Coruña
• Study Sponsor: Complexo Hospitalario Universitario de A Coruña
• Collaborators: Not Provided

Investigators

• Principal Investigator: Jose L Ponce, MD; Complejo Hospitalario Universitario A Coruña

• PRS Account: Complexo Hospitalario Universitario de A Coruña
• Verification Date: January 2018