Endometrial BiopsyNCT06546254
1% Lidocaine Paracervical Block for Endometrial Biopsy
A study testing Lidocaine 1% Injectable Solution and Capped needle in people with Endometrial Biopsy, run by Mount Sinai Hospital, Canada at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometrial Biopsy
- What is being tested?
- Lidocaine 1% Injectable Solution and Capped needle
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteCanada
- Study dates
- 19 Jun 2025to 22 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any participant > or = age 18 years old presenting for an endometrial biopsy
- All parities of patients are eligible
- English speaking participants only
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind Randomized Controlled Trial of 1% Lidocaine Paracervical Block for Endometrial Biopsy
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:
- intervention (paracervical block - 10 mL 1% lidocaine with epinephrine)
- 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.
- Conditions
- Endometrial Biopsy
- Being tested
- Lidocaine 1% Injectable Solution, Capped needle
- Keywords
- lidocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine 1% Injectable SolutionDrug
10 cc 1% lidocaine paracervical injection
Capped needleOther
Tapping the cervicovaginal junction with a capped needle
| Study group | Role | What they receive |
|---|---|---|
| 1% lidocaine paracervical injection | Experimental | 10 cc 1% lidocaine with epinephrine paracervical injection Receives: Drug: Lidocaine 1% Injectable Solution |
| control | Sham comparator | gently tapping the cervicovaginal junction with a capped needle Receives: Other: Capped needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global pain score
100 mm Visual Analogue Scale (VAS), minimum value 0 (no pain at all) and maximum value 100 (worst pain imaginable)
Measured: Immediately after the completion of the procedure
Secondary outcomes (8)
Pain scores during procedure
Pain rating on scale of 0 - 10 at the following time points: baseline, after injection/control, placement of tenaculum, endometrial biopsy completion, 1-minute post-biopsy
Measured: During the procedure
Immediate complications of endometrial biopsy and/or intervention/control
Provider reported
Measured: Immediately after the completion of the procedure
Difficulty for provider to complete the biopsy
Provider reported on Likert scale, minimum 1 (least difficult) and maximum 5 (most difficult)
Measured: Immediately after the completion of the procedure
Length of time for analgesia
Stopwatch
Measured: During procedure
Length of time for endometrial biopsy completion
Stopwatch
Measured: During procedure
Number of passes with biopsy pipelle to collect sufficient tissue
Provider reported
Measured: Immediately after the completion of the procedure
Amount of tissue obtained: scant, minimal, adequate
Provider reported
Measured: Immediately after the completion of the procedure
Patient satisfaction
Survey
Measured: Immediately after the completion of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start19 Jun 2025
- Primary completion22 Jan 2026
- Study completion22 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial BiopsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The proposed study is a double-blind randomized controlled trial. Participants will be recruited from Mount Sinai Hospital outpatient gynecology clinics. Recruitment, consent, randomization, procedure, and post-procedure survey will occur during the same visit. Each participant will be randomly assigned to one of two arms: 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mara Sobel, Mount Sinai Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06546254
- Sponsor's protocol ID
- REB 23-0078-A
- Status last verified
- Jan 2026
- First submitted
- 1 Aug 2024
- Last updated
- 27 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind Randomized Controlled Trial of 1% Lidocaine Paracervical Block for Endometrial Biopsy
- ClinicalTrials.gov ID
- NCT06546254
- Acronym / sponsor ID
- REB 23-0078-A
- Conditions
- Endometrial Biopsy
- Keywords
- lidocaine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Study start
- 19 Jun 2025 (actual)
- Primary completion
- 22 Jan 2026 (actual)
- Study completion
- 22 Jan 2026 (actual)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- intervention (paracervical block - 10 mL 1% lidocaine with epinephrine)
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- The proposed study is a double-blind randomized controlled trial. Participants will be recruited from Mount Sinai Hospital outpatient gynecology clinics. Recruitment, consent, randomization, procedure, and post-procedure survey will occur during the same visit. Each participant will be randomly assigned to one of two arms: 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.
| Arm | Type | Receives |
|---|---|---|
| 1% lidocaine paracervical injection | Experimental | Drug: Lidocaine 1% Injectable Solution10 cc 1% lidocaine with epinephrine paracervical injection |
| control | Sham comparator | Other: Capped needlegently tapping the cervicovaginal junction with a capped needle |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Any participant > or = age 18 years old presenting for an endometrial biopsy
- All parities of patients are eligible
- English speaking participants only
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine 1% Injectable Solution10 cc 1% lidocaine paracervical injection | Drug | 1% lidocaine paracervical injection |
| Capped needleTapping the cervicovaginal junction with a capped needle | Other | control |
Primary outcome
Global pain score
Time frame: Immediately after the completion of the procedure
100 mm Visual Analogue Scale (VAS), minimum value 0 (no pain at all) and maximum value 100 (worst pain imaginable)
8 secondary outcomes
Pain scores during procedure
Time frame: During the procedure
Immediate complications of endometrial biopsy and/or intervention/control
Time frame: Immediately after the completion of the procedure
Difficulty for provider to complete the biopsy
Time frame: Immediately after the completion of the procedure
Length of time for analgesia
Time frame: During procedure
Length of time for endometrial biopsy completion
Time frame: During procedure
Number of passes with biopsy pipelle to collect sufficient tissue
Time frame: Immediately after the completion of the procedure
Amount of tissue obtained: scant, minimal, adequate
Time frame: Immediately after the completion of the procedure
Patient satisfaction
Time frame: Immediately after the completion of the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: No
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Endometrial Biopsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine 1% Injectable Solution and Capped needle in people with Endometrial Biopsy, run by Mount Sinai Hospital, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global pain score (time frame: Immediately after the completion of the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.