1% Lidocaine Paracervical Block for Endometrial Biopsy

NCT06546254 | Completed

• 1 other identifier: REB 23-0078-A
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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:

1. 1.intervention (paracervical block - 10 mL 1% lidocaine with epinephrine)
2. 2.control (gently tapping the cervicovaginal junction with a capped needle)

Conditions

Endometrial Biopsy

Keywords

lidocaine

Outcome Measures

Primary Outcomes (1)

• 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 (8)

• Pain scores during procedure

  During the procedure

• Immediate complications of endometrial biopsy and/or intervention/control

  Immediately after the completion of the procedure

• Difficulty for provider to complete the biopsy

  Immediately after the completion of the procedure

• Length of time for analgesia

  During procedure

• Length of time for endometrial biopsy completion

  During procedure

Study Arms (2)

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

Lidocaine 1% Injectable Solution DRUG

10 cc 1% lidocaine paracervical injection

1% lidocaine paracervical injection

Capped needle OTHER

Tapping the cervicovaginal junction with a capped needle

control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any participant \> or = age 18 years old presenting for an endometrial biopsy
• All parities of patients are eligible
• English speaking participants only

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead

Study Sites (1)

OPG

Toronto, Ontario, M5G 1Z5, Canada

Location

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator (Dr.)

Model Details: 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.

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: August 9, 2024
• Study Start: June 19, 2025
• Primary Completion: January 22, 2026
• Study Completion: January 22, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)