CREMS Prostate Biopsy Pain Relief Study

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01365871
• Other study ID #: TOI-CREMS
• Status: Completed
• Phase: N/A
• First received: May 27, 2011
• Last updated: January 17, 2012
• Start date: June 2011
• Est. completion date: December 2011

Study information

• Verified date: January 2012
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

• Men who come for prostate biopsy

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pain

Intervention

Procedure:
• anesthetics injection
Basal injection of anesthetics or basal + apical injection of anesthetics.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	University of Toronto

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain scores comparing two groups.	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	No
Secondary	Incidence of side effects and complications.	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	Yes