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A method of pain reduction during prostate biopsy

Compare the effect of intrarectal lidocaine gel and lidocaine gel in combination with fentanyl in pain reduction during in patients undergoing prostate biopsy: a clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201612013773N17
Enrollment
96
Registered
2017-01-22
Start date
2016-05-21
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

Dysplasia of prostate. Dysplasia of Prostate, Low grade dysplasia

Interventions

Intervention 1: Intervention Group: intrarectal administration of 50 gr lidocaine gel (2%) produced by Sina daro company and 50 mcg fentanyl produced by Rasht-Iran company. Intervention 2: Control Gro
Treatment - Drugs
Prevention
Intervention Group: intrarectal administration of 50 gr lidocaine gel (2%) produced by Sina daro company and 50 mcg fentanyl produced by Rasht-Iran company.
Control Group: intrarectal administration of 50 gr lidocaine gel 2% prodused by Sina daro company.

Sponsors

Vice chancellor for research of Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
30 Years to 80 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Patients candidate for prostate biopsy; Minimum weight 40 kg Exclusion criteria: uncontrolled blood pressure; sensitivity to local anesthetics; advanced heart, renal or hepatic disease; opioid addiction.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Pain. Timepoint: Before and During Biopsy. Method of measurement: VAS Score.;Blood Pressure. Timepoint: Before and During Biopsy. Method of measurement: Monitoring.;Heart Rate. Timepoint: Before and During Biopsy. Method of measurement: Pulse Oximetry.

Secondary

MeasureTime frame
Level of consciousness. Timepoint: Before and during biopsy. Method of measurement: Miller Score.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.Farsad Imani

Tehran University of Medical Sciences

imanifar@tums.ac.ir+98 21 4469 0816

Outcome results

None listed

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