Comparison of Transrectal prescription of Liddocain Jel and Liddocain Jel with diltiazem and Liddocain Jel with meperidine upon Pain during Prostate Biopsy

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201211153773N7

Enrollment

Registered

2013-01-29

Start date

2012-04-18

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Pain during Prostate biopsy. Pelvic and perineal pain

Interventions

Intervention 1: First group 50 gr intrarectal Lidocaine is administrated. During insertion of probe and biopsy pain is evaluated by VAS score. Meantime Blood pressure & Heart rate will be monitored. A

Treatment - Drugs

First group 50 gr intrarectal Lidocaine is administrated. During insertion of probe and biopsy pain is evaluated by VAS score. Meantime Blood pressure & Heart rate will be monitored. After biopsy aler

Secnd group 1 gr Diltiazem around Anus & 50 gr intrarectal Lidocaine is administrated. During insertion of probe and biopsy pain is evaluated by VAS score. Meantime Blood pressure & Heart rate will be

Third group 1 gr Diltiazem & 50 gr Lidocaine & 25 mg Meperidin intrarectal is administrated. During insertion of probe and biopsy pain is evaluated by VAS score. Meantime Blood pressure & Heart rate w

Eligibility

Sex/Gender

Male

Age

30 Years to 99 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Patients candidate for Prostate Biopsy (high PSA or abnormal rectal biopsy), least weigh 40 kg. Exclusion criteria: uncontrolled high blood pressure, prohibition of local anesthesia drug, advanced cardiac, renal, liver disease

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Pain. Timepoint: during insertion of Probe & biopsy of Prostate. Method of measurement: VAS Questionare.	—

Secondary

Measure	Time frame
Arterial Blood Pressure. Timepoint: during insertion of Probe & biopsy of Prostate. Method of measurement: Non invasive Blood pressure monitoring.;Heart Rate. Timepoint: during insertion of Probe & biopsy of Prostate. Method of measurement: Monitoring.;Alertness. Timepoint: After biopsy. Method of measurement: Miller Questionare.;Vomiting / Nausea. Timepoint: During & after Biopsy. Method of measurement: Observation.	—

Measure

Time frame

Arterial Blood Pressure. Timepoint: during insertion of Probe & biopsy of Prostate. Method of measurement: Non invasive Blood pressure monitoring.;Heart Rate. Timepoint: during insertion of Probe & biopsy of Prostate. Method of measurement: Monitoring.;Alertness. Timepoint: After biopsy. Method of measurement: Miller Questionare.;Vomiting / Nausea. Timepoint: During & after Biopsy. Method of measurement: Observation.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactFarsad Imani

Tehran University of Medical Sciences

imanifar@tums.ac.ir+98 21 63120

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026