CREMS Prostate Biopsy Pain Relief Study

January 17, 2012 updated by: University Health Network, Toronto

Pain Relief With Local Anesthetic at Time of Prostate Biopsy: Comparing Apical and Basal Injection Versus Basal Injection Alone

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Men who come for prostate biopsy

Exclusion Criteria:

  • Men who are unwilling or unable to consent and fill in the forms

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
post prostate biopsy procedure up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
post prostate biopsy procedure up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Collaborators

University of Toronto

Investigators

  • Principal Investigator: Ants Toi, MD, University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

May 27, 2011

First Submitted That Met QC Criteria

June 1, 2011

First Posted (Estimate)

June 3, 2011

Study Record Updates

Last Update Posted (Estimate)

January 18, 2012

Last Update Submitted That Met QC Criteria

January 17, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TOI-CREMS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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