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

CREMS Prostate Biopsy Pain Relief Study

Sponsors

Lead sponsor: University Health Network, Toronto

Collaborator: University of Toronto

Source 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.

Overall Status Completed
Start Date June 2011
Completion Date December 2011
Primary Completion Date December 2011
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Pain scores comparing two groups. post prostate biopsy procedure up to 6 months
Secondary Outcome
Measure Time Frame
Incidence of side effects and complications. post prostate biopsy procedure up to 6 months
Enrollment 300
Condition
Intervention

Intervention type: Procedure

Intervention name: anesthetics injection

Description: Basal injection of anesthetics or basal + apical injection of anesthetics.

Eligibility

Criteria:

Inclusion Criteria:

- Men who come for prostate biopsy

Exclusion Criteria:

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

Gender: Male

Minimum age: 30 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Ants Toi, MD Principal Investigator University Health Network, Toronto
Verification Date

January 2012

Responsible Party

Name title: Dr. Ants Toi

Organization: University Health Network, Toronto, Ontario, Canada

Keywords
Has Expanded Access No
Number Of Arms 2
Arm Group

Arm group label: basal injection

Arm group type: Active Comparator

Description: basal injection of anesthetics

Arm group label: basal + apical injection

Arm group type: Active Comparator

Description: basal + apical injection of anesthetics

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: None (Open Label)

Source: ClinicalTrials.gov