CREMS Prostate Biopsy Pain Relief Study

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Men who come for prostate biopsy

Exclusion criteria

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

Treatment and study plan

anesthetics injection

Procedure

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

Primary outcomes

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.

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

University of Toronto

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2011
Study completion: 2011
First posted: Jun 3, 2011
Registry last updated: Jan 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed