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CREMS Prostate Biopsy Pain Relief Study

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01365871
Enrollment
300
Registered
2011-06-03
Start date
2011-06-30
Completion date
2011-12-31
Last updated
2012-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

prostate biopsy, pain

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.

Interventions

PROCEDUREanesthetics injection

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

Sponsors

University of Toronto
CollaboratorOTHER
University Health Network, Toronto
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
30 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Men who come for prostate biopsy

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Pain scores comparing two groups.post prostate biopsy procedure up to 6 monthsPain 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

MeasureTime frameDescription
Incidence of side effects and complications.post prostate biopsy procedure up to 6 monthsQuestionnaires will be asked to filled in to assess side effects and complications at 2-4 weeks and at 6-month post procedure.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026