1% Lidocaine Paracervical Block for Endometrial Biopsy

Not Applicable

Recruiting

• Conditions: Endometrial Biopsy
• Interventions: Drug: Lidocaine 1% Injectable Solution; Other: Capped needle

• Registration Number: NCT06546254
• Lead Sponsor: Mount Sinai Hospital, Canada

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. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-01
• Study First Submitted QC: 2024-08-06
• Study First Posted: 2024-08-09
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-10
• Study Start: 2025-06-12
• Last Update Posted: 2025-06-13
• Primary Completion: 2025-08-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 96

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1% lidocaine paracervical injection	Lidocaine 1% Injectable Solution	10 cc 1% lidocaine with epinephrine paracervical injection
control	Capped needle	gently tapping the cervicovaginal junction with a capped needle

Primary Outcome Measures

Name	Time	Method
Global pain score	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)

Secondary Outcome Measures

Name	Time	Method
Immediate complications of endometrial biopsy and/or intervention/control	Immediately after the completion of the procedure	Provider reported
Difficulty for provider to complete the biopsy	Immediately after the completion of the procedure	Provider reported on Likert scale, minimum 1 (least difficult) and maximum 5 (most difficult)
Length of time for endometrial biopsy completion	During procedure	Stopwatch
Length of time for analgesia	During procedure	Stopwatch
Number of passes with biopsy pipelle to collect sufficient tissue	Immediately after the completion of the procedure	Provider reported
Amount of tissue obtained: scant, minimal, adequate	Immediately after the completion of the procedure	Provider reported
Pain scores during procedure	During the 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
Patient satisfaction	Immediately after the completion of the procedure	Survey

Trial Locations

Locations (1)

OPG; 🇨🇦 Toronto, Ontario, Canada