CREMS Prostate Biopsy Pain Relief Study

University Health Network, Toronto

Status: Completed

Conditions: Pain

Treatments: Procedure: anesthetics injection

Study type: Interventional

Funder types: Other

Identifiers

NCT01365871

TOI-CREMS

Details and patient eligibility

About

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.

Enrollment: 300 patients

Sex: Male

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men who come for prostate biopsy

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

basal injection

Active Comparator group

Description:

basal injection of anesthetics

Treatment:

Procedure: anesthetics injection

basal + apical injection

Active Comparator group

Description:

basal + apical injection of anesthetics

Treatment:

Procedure: anesthetics injection