1% Lidocaine Paracervical Block for Endometrial Biopsy | NCT06546254

Studies
1% Lidocaine Paracervical Block for Endometrial Biopsy

NCT06546254

Sponsor

Mount Sinai Hospital, Canada

Status

Completed

Last Update Posted

Jan 27, 2026Actual

Enrollment

96Actual

Phase

Not Applicable

Conditions

Endometrial Biopsy

Interventions

Lidocaine 1% Injectable Solution
Capped needle

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 19, 2025Actual

Primary Completion Date

Jan 22, 2026Actual

Completion Date

Jan 22, 2026Actual

First Submitted Date

Aug 1, 2024

First Submission Date that Met QC Criteria

Aug 6, 2024

First Posted Date

Aug 9, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 24, 2026

Last Update Posted Date

Jan 27, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mara Sobel, Prinicipal Investigator (Dr.), Mount Sinai Hospital, CanadaPrincipal Investigator

Lead Sponsor

Mount Sinai Hospital, CanadaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief 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:

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

96Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1% lidocaine paracervical injection	Experimental	10 cc 1% lidocaine with epinephrine paracervical injection	Drug: Lidocaine 1% Injectable Solution
control	Sham Comparator	gently tapping the cervicovaginal junction with a capped needle	Other: Capped needle

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lidocaine 1% Injectable Solution	Drug	10 cc 1% lidocaine paracervical injection	1% lidocaine paracervical injection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Global pain score	100 mm Visual Analogue Scale (VAS), minimum value 0 (no pain at all) and maximum value 100 (worst pain imaginable)	Immediately after the completion of the procedure

Secondary Outcomes

Measure	Description	Time Frame
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	During the procedure
Immediate complications of endometrial biopsy and/or intervention/control

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
OPG		Toronto	Ontario	M5G 1Z5	Canada

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008012	Lidocaine

Ancestor Terms

ID	Term
D000083	Acetanilides
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention 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:

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.

Masking Info

Masking

Triple

Masking Description

The investigators will employ a two provider system to ensure a double-blinded set-up. The first provider (Provider A) will open the allocation envelopes without the presence of the participant or second provider (Provider B).

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.

Who Masked

ParticipantCare ProviderInvestigator