Prostatic CancerPhase 4NCT02909049
Clinical Trial to Examine Individual Pain Tolerance in the Use of Two Anesthetic Techniques to Perform Saturation Prostate Biopsy
A Phase 4 study testing MIDAZOLAM, MEPIVACAÍNE and FENTANILE in people with Prostatic Cancer, run by Complexo Hospitalario Universitario de A Coruña at 1 site in Spain.
Trial summary
To assess the effectiveness of two anesthetic techniques by measuring the pain through visual analog scale (VAS), to obtain saturation prostate biopsies. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Prostatic Cancer
- What is being tested?
- MIDAZOLAM, MEPIVACAÍNE and FENTANILE
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2016to 24 Jan 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Randomized Clinical Trial to Examine Individual Pain Tolerance in the Use of Two Anesthetic Techniques to Perform Saturation Prostate Biopsy
To assess the effectiveness of two anesthetic techniques by measuring the pain through visual analog scale (VAS), to obtain saturation prostate biopsies.
Read the 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.
- Conditions
- Prostatic Cancer
- Keywords
- Prostate Biopsy, Local Anesthesia, Pain, Biopsy of prostate
- Medical subject headings
- Prostatic Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIDAZOLAMDrug
Also called MIDAZOLAM 15mg/3ml ATC N05CD08 MAN 65319
Intravenous bolus anesthesia 5 minutes previous to saturation prostate biopsy.
MEPIVACAÍNEDrug
Also called MEPIVACAINE 2% ATC N01BB03 MAN 62606
Local periprostatic anesthesia infiltration, previous to saturation prostate biopsy.
FENTANILEDrug
Also called FENTANILE 0,05 mg/ml ATC N01AH01 MAN 41764
Intravenous bolus anesthesia 3 minutes previous to saturation prostate biopsy.
KETAMINEDrug
Also called KETAMINE 50 mg/ml ATC N01AX03 Marketing Authorisation number 47034
Intravenous bolus anesthesia 1 minute previous to saturation prostate biopsy.
| Study group | Role | What they receive |
|---|---|---|
| CONTROL | Active comparator | 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 Receives: 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. Receives: Drug: MEPIVACAÍNE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in visual analog scale (VAS)
Change in visual analog scale (VAS) from baseline and after prostate biopsy
Measured: 1 hour baseline
Secondary outcomes (1)
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.
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.
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study startApr 2016
- Primary completion24 Jan 2018
- Study completion24 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Complexo Hospitalario Universitario de A Coruña
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José Luis Ponce Díaz-Reixa, Complexo Hospitalario Universitario de A Coruña
- Investigators
- Jose L Ponce, MD, Principal investigator, Complejo Hospitalario Universitario, A Coruña
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02909049
- Sponsor's protocol ID
- URO - CHUAC - BPSat - 001.
- Status last verified
- Jan 2018
- First submitted
- 19 Apr 2016
- Last updated
- 26 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Randomized Clinical Trial to Examine Individual Pain Tolerance in the Use of Two Anesthetic Techniques to Perform Saturation Prostate Biopsy
- ClinicalTrials.gov ID
- NCT02909049
- Acronym / sponsor ID
- URO - CHUAC - BPSat - 001.
- Conditions
- Prostatic Cancer
- Keywords
- Prostate Biopsy, Local Anesthesia, Pain, Biopsy of prostate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Complexo Hospitalario Universitario de A CoruñaUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- 24 Jan 2018 (actual)
- Study completion
- 24 Jan 2018 (actual)
- First posted
- 21 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CONTROL | Active comparator | Drug: MIDAZOLAM, Drug: FENTANILE, Drug: KETAMINESaturation 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 |
| EXPERIMENTAL | Experimental | Drug: MEPIVACAÍNESaturation prostate biopsy under local anesthesia MEPIVACAÍNE 2% 10 millimeters periprostatic block at base and ápex, bilaterally. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MIDAZOLAMAlso: MIDAZOLAM 15mg/3ml ATC N05CD08 MAN 65319Intravenous bolus anesthesia 5 minutes previous to saturation prostate biopsy. | Drug | CONTROL |
| MEPIVACAÍNEAlso: MEPIVACAINE 2% ATC N01BB03 MAN 62606Local periprostatic anesthesia infiltration, previous to saturation prostate biopsy. | Drug | EXPERIMENTAL |
| FENTANILEAlso: FENTANILE 0,05 mg/ml ATC N01AH01 MAN 41764Intravenous bolus anesthesia 3 minutes previous to saturation prostate biopsy. | Drug | CONTROL |
| KETAMINEAlso: KETAMINE 50 mg/ml ATC N01AX03 Marketing Authorisation number 47034Intravenous bolus anesthesia 1 minute previous to saturation prostate biopsy. | Drug | CONTROL |
Primary outcome
Change in visual analog scale (VAS)
Time frame: 1 hour baseline
Change in visual analog scale (VAS) from baseline and after prostate biopsy
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2018.
- Individual participant dataSharing planned: No
Related trials for Prostatic Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose L Ponce, MD principal investigator
Complejo Hospitalario Universitario, A Coruña
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MIDAZOLAM, MEPIVACAÍNE and FENTANILE in people with Prostatic Cancer, run by Complexo Hospitalario Universitario de A Coruña at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in visual analog scale (VAS) (time frame: 1 hour baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2018.