CREMS Prostate Biopsy Pain Relief Study

NCT ID: NCT01365871

Last Updated: 2012-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2011-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

basal injection

basal injection of anesthetics

Group Type ACTIVE_COMPARATOR

anesthetics injection

Intervention Type PROCEDURE

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

basal + apical injection

basal + apical injection of anesthetics

Group Type ACTIVE_COMPARATOR

anesthetics injection

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

anesthetics injection

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Men who come for prostate biopsy

Exclusion Criteria

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

30 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Toronto

OTHER

Sponsor Role collaborator

University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

University Health Network, Toronto, Ontario, Canada

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ants Toi, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TOI-CREMS

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Anti-tumour Activity of (177Lu) rhPSMA-10.1 Injection
NCT05413850 RECRUITING PHASE1/PHASE2