CompletedNot Applicable

Anorectal Application of 5% Lidocaine Cream Reduces Pain Prior to Periprostatic Nerve Block During Transrectal Ultrasound Guided Biopsy

284 participantsStarted 2016-12

Plain-language summary

Transrectal ultrasound guided prostate biopsy is performed with a periprostatic nerve block to the neurovascular bundle bilaterally. This does not reduce the pain due to probe insertion and manipulation prior to nerve blockage. Our study goal is to assess whether topical analgesia would reduce pain during the early stages of the procedure.

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Males referred to TRUSGBx due to elevated prostate specific antigen (PSA) * Abnormal findings on digital rectal examination (DRE) * Repeat biopsies as part of Active Surveillance (AS) * Continuously elevated PSA levels despite prior negative for malignancy biopsies * Previous histological findings of significant HGPIN were enrolled Exclusion Criteria: * Known sensitivity to Lidocaine * Pre-planned biopsy under general anesthesia

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pain level before probe insertion

Timeframe: Before transrectal ultrasound probe insertion

Pain level at TRUS probe insertion

Timeframe: During transrectal ultrasound probe insertion into the rectum (defined as beginning of procedure)

Pain level during TRUS probe manipulation in the rectum

Timeframe: During transrectal ultrasound probe manipulation in the rectum (estimated at 0-2 minutes length)

Pain level during periprostatic nerve block

Timeframe: During periprostatic nerve block (rectal wall puncture with needle, estimated at 2-3 minutes after beginning of procedure)

Pain level during biopsy collection

Timeframe: During biopsy collection using an 18-gauge needle (estimated at 3-10 minutes from beginning of procedure)

Pain level at termination of procedure

Timeframe: At termination of procedure (total estimated length of procedure is 10 minutes).

Trial details

NCT IDNCT04064047

SponsorAssaf-Harofeh Medical Center

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2017-07

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