CREMS Prostate Biopsy Pain Relief Study

This study has been completed.
Sponsor:
Collaborator:
University of Toronto
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01365871
First received: May 27, 2011
Last updated: January 17, 2012
Last verified: January 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   30 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01365871

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

No publications provided

Responsible Party: Dr. Ants Toi, University Health Network, Toronto, Ontario, Canada
ClinicalTrials.gov Identifier: NCT01365871     History of Changes
Other Study ID Numbers: TOI-CREMS
Study First Received: May 27, 2011
Last Updated: January 17, 2012
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 21, 2014