The effect of heated lidocaine gel to reduce pain during prostate biopsy

Comparison of intrarectal heated lidocaine gel and periprostatic nerve block for pain control in transrectal ultrasound-guided prostate biopsy: a randomized controlled noninferiority trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0004584

Enrollment

100

Registered

2019-12-24

Start date

2019-10-24

Completion date

Unknown

Last updated

2020-01-14

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

Conditions

None listed

Interventions

Drug : In group 1 (heated lidocaine gel grooup) ten minutes before the biopsy,20 cc of 2&#37

heated (35-40 degree) lidocain gel was administered intrarectally In group 2, before the biopsy,periprostatic nerve block with 2&#37

lidocain inject was performed.

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: The indications of prostate biopsy were abnormally elevated PSA level (>4.0 ng/mL), abnormal digital rectal examination, or a combination of these.

Exclusion criteria

Exclusion criteria: Those who had had a previous TRUS-guided biopsy, chronic prostatitis/pelvic pain, neurological conditions, bleeding diathesis, anticoagulation/antiplatelet therapy, active UTI,haemorrhoids/anal fissure/anal fistula, or known allergy to lignocaine were excluded from the study.

Design outcomes

Primary

Measure	Time frame
VAS (Visual analog scale) score	—

Secondary

Measure	Time frame
bleeding complications (hematuria, rectal bleeding, hematospermia);infection complications (fever, sepsis);lidocaine gel complications (hypotesion, hypersensitvity, sleepiness)	—

Countries

Korea, Republic of

Contacts

Public ContactBong Hee Park

The Catholic University of Korea, Uijeongbu St. Mary’s Hospital

Outcome results