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CREMS Prostate Biopsy Pain Relief Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01365871
First Posted: June 3, 2011
Last Update Posted: January 18, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Toronto
Information provided by:
University Health Network, Toronto
  Purpose
The current standard for pain relief during prostate biopsy is the injection of local anesthetic agents into or around the prostate at various sites including apex, base, lateral aspects and into the prostate itself. Despite such anesthetic injection, some men still experience severe pain and often at the base of the penis. The study audits current practices comparing the degree of pain relief provided by injection at basal versus basal+apical sites. All these injection sites are standard practice at our hospital.

Condition Intervention
Pain Procedure: anesthetics injection

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Pain Relief With Local Anesthetic at Time of Prostate Biopsy: Comparing Apical and Basal Injection Versus Basal Injection Alone

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Pain scores comparing two groups. [ Time Frame: post prostate biopsy procedure up to 6 months ]
    Pain questionnaires will be asked to filled in before the procedure, within 20 minutes of the procedure, at 2-4 weeks and at 6-month post procedure.


Secondary Outcome Measures:
  • Incidence of side effects and complications. [ Time Frame: post prostate biopsy procedure up to 6 months ]
    Questionnaires will be asked to filled in to assess side effects and complications at 2-4 weeks and at 6-month post procedure.


Enrollment: 300
Study Start Date: June 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: basal injection
basal injection of anesthetics
Procedure: anesthetics injection
Basal injection of anesthetics or basal + apical injection of anesthetics.
Active Comparator: basal + apical injection
basal + apical injection of anesthetics
Procedure: anesthetics injection
Basal injection of anesthetics or basal + apical injection of anesthetics.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men who come for prostate biopsy

Exclusion Criteria:

  • Men who are unwilling or unable to consent and fill in the forms
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01365871


Sponsors and Collaborators
University Health Network, Toronto
University of Toronto
Investigators
Principal Investigator: Ants Toi, MD University Health Network, Toronto
  More Information

Responsible Party: Dr. Ants Toi, University Health Network, Toronto, Ontario, Canada
ClinicalTrials.gov Identifier: NCT01365871     History of Changes
Other Study ID Numbers: TOI-CREMS
First Submitted: May 27, 2011
First Posted: June 3, 2011
Last Update Posted: January 18, 2012
Last Verified: January 2012

Keywords provided by University Health Network, Toronto:
prostate biopsy
pain

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs