Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
96 participants
INTERVENTIONAL
2025-06-19
2025-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
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.
OTHER
TRIPLE
Provider A will then enter the patient's room and introduce themselves. Provider A will place the speculum, and administer either the intervention or control and then leave the room after injection-related bleeding has stopped. After 3 minutes, the second provider (Provider B) will enter the room to place the tenaculum and perform the endometrial biopsy and will be unaware of the participant's treatment arm.
A standardized script will be used with all participants: "You may or not may feel a poke."
Both lidocaine and the control are odorless and clear, minimizing the risk of unblinding. All data will remain blinded until data analysis.
Study Groups
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1% lidocaine paracervical injection
10 cc 1% lidocaine with epinephrine paracervical injection
Lidocaine 1% Injectable Solution
10 cc 1% lidocaine paracervical injection
control
gently tapping the cervicovaginal junction with a capped needle
Capped needle
Tapping the cervicovaginal junction with a capped needle
Interventions
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Lidocaine 1% Injectable Solution
10 cc 1% lidocaine paracervical injection
Capped needle
Tapping the cervicovaginal junction with a capped needle
Eligibility Criteria
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Inclusion Criteria
* All parities of patients are eligible
* English speaking participants only
Exclusion Criteria
* 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)
18 Years
FEMALE
Yes
Sponsors
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Mount Sinai Hospital, Canada
OTHER
Responsible Party
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Mara Sobel
Prinicipal Investigator (Dr.)
Locations
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OPG
Toronto, Ontario, Canada
Countries
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Facility Contacts
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Other Identifiers
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REB 23-0078-A
Identifier Type: -
Identifier Source: org_study_id
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