NCT01365871

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Jun 2011

Shorter than P25 for not_applicable pain

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2011

Completed
5 days until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

January 18, 2012

Status Verified

January 1, 2012

Enrollment Period

6 months

First QC Date

May 27, 2011

Last Update Submit

January 17, 2012

Conditions

Pain

Keywords

prostate biopsypain

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Incidence of side effects and complications.

    post prostate biopsy procedure up to 6 months

Study Arms (2)

basal injection

ACTIVE COMPARATOR

basal injection of anesthetics

Procedure: anesthetics injection

basal + apical injection

ACTIVE COMPARATOR

basal + apical injection of anesthetics

Procedure: anesthetics injection

Interventions

anesthetics injectionPROCEDURE

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

basal + apical injectionbasal injection

Eligibility Criteria

Age30 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men who come for prostate biopsy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain

Interventions

Anesthetics

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Central Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesCentral Nervous System AgentsTherapeutic Uses

Study Officials

  • Ants Toi, MD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 27, 2011

First Posted

June 3, 2011

Study Start

June 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

January 18, 2012

Record last verified: 2012-01