CompletedNot Applicable

1% Lidocaine Paracervical Block for Endometrial Biopsy

Canada96 participantsStarted 2025-06-19

Plain-language summary

The objective of this study is to to determine whether 1% lidocaine paracervical block reduces pain during endometrial biopsy in comparison to no intervention. The proposed study is a double-blind randomized controlled trial (RCT). Each participant will be randomly assigned to one of two arms: 1. intervention (paracervical block - 10 mL 1% lidocaine with epinephrine) 2. control (gently tapping the cervicovaginal junction with a capped needle) The primary outcome will be a global pain score, which will be patient-reported by the 100 mm Visual Analogue Scale (VAS) following the procedure.

Who can participate

Age range

18 Years

Sex

FEMALE

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 * Any participant \> or = age 18 years old presenting for an endometrial biopsy * All parities of patients are eligible * English speaking participants only Exclusion Criteria * Use of pain medication that is not an NSAID or acetaminophen (e.g. opioids, benzos) within past 24 hours * Confirmed pregnancy * Any diagnosed chronic pain syndromes (eg. fibromyalgia, vaginismus, interstitial cystitis) * Contraindication to lidocaine * Misoprostol administration within 24 hours * Previous unsuccessful office attempt at endometrial biopsy by the same practitioner (note of clarification: previous unsuccessful biopsy attempt by a different practitioner will still be eligible)

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

Global pain score

Timeframe: Immediately after the completion of the procedure

Trial details

NCT IDNCT06546254

SponsorMount Sinai Hospital, Canada

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01-22

View on ClinicalTrials.gov More Endometrial Biopsy trials