1% Lidocaine Paracervical Block for Endometrial Biopsy

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:

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.

Study Overview

• Status: Completed
• Conditions: Endometrial Biopsy
• Intervention / Treatment: Drug: Lidocaine 1% Injectable Solution; Other: Capped needle

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1Z5
      • OPG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1% lidocaine paracervical injection; 10 cc 1% lidocaine with epinephrine paracervical injection	Drug: Lidocaine 1% Injectable Solution; 10 cc 1% lidocaine paracervical injection
Sham Comparator: control; gently tapping the cervicovaginal junction with a capped needle	Other: Capped needle; Tapping the cervicovaginal junction with a capped needle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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	Provider reported	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)	Immediately after the completion of the procedure
Length of time for analgesia	Stopwatch	During procedure
Length of time for endometrial biopsy completion	Stopwatch	During procedure
Number of passes with biopsy pipelle to collect sufficient tissue	Provider reported	Immediately after the completion of the procedure
Amount of tissue obtained: scant, minimal, adequate	Provider reported	Immediately after the completion of the procedure
Patient satisfaction	Survey	Immediately after the completion of the procedure

Collaborators and Investigators

• Sponsor: Mount Sinai Hospital, Canada

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2025
• Primary Completion (Actual): January 22, 2026
• Study Completion (Actual): January 22, 2026

Study Registration Dates

• First Submitted: August 1, 2024
• First Submitted That Met QC Criteria: August 6, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Actual): January 27, 2026
• Last Update Submitted That Met QC Criteria: January 24, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: lidocaine
• Additional Relevant MeSH Terms: Organic Chemicals; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Lidocaine
• Other Study ID Numbers: REB 23-0078-A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes