CREMS Prostate Biopsy Pain Relief Study

Not Applicable

Completed

• Conditions: Pain
• Interventions: Procedure: anesthetics injection

• Registration Number: NCT01365871
• Lead Sponsor: University Health Network, Toronto

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-05-27
• Study Start: 2011-06
• Study First Submitted QC: 2011-06-01
• Study First Posted: 2011-06-03
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-17
• Last Update Posted: 2012-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 300

Inclusion Criteria

• Men who come for prostate biopsy

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
basal injection	anesthetics injection	basal injection of anesthetics
basal + apical injection	anesthetics injection	basal + apical injection of anesthetics

Primary Outcome Measures

Name	Time	Method
Pain scores comparing two groups.	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

Name	Time	Method
Incidence of side effects and complications.	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.