1% Lidocaine Paracervical Block for Endometrial Biopsy

Not Applicable

Not yet recruiting

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

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

Brief Summary

The objective of this study is to determine whether 1% lidocaine paracervical block reduces pain during endometrial biopsy in comparison to sham paracervical injection with normal saline or no intervention.

The proposed study is a double-blind, triple arm, placebo-controlled randomized controlled trial (RCT). Each participant will be randomly assigned to one of three arms:

1. intervention (paracervical block - 10 cc 1% lidocaine with epinephrine)

2. placebo (10 cc paracervical injection of normal saline)

3. 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

• Status Verified: 2024-08
• Study First Submitted: 2024-08-01
• Study Start: 2024-08-05
• Study First Submitted QC: 2024-08-06
• Last Update Submitted: 2024-08-06
• Study First Posted: 2024-08-09
• Last Update Posted: 2024-08-09
• Primary Completion: 2025-08-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 174

Inclusion Criteria

• = or > 18 years old presenting for endometrial biopsy
• All parities
• English-speaking participant

Exclusion Criteria

• Use of pain medication that is not non-steroidal anti-inflammatory (NSAID) or acetaminophen in the past 24 hours
• Confirmed pregnancy
• Any diagnosed chronic pain syndromes
• Contraindication to lidocaine
• Misoprostol administration within 24 hours
• Previous unsuccessful office attempt of endometrial biopsy by same practitioner

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
normal saline paracervical injection	Saline	10 cc normal saline paracervical injection

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
Patient satisfaction	Immediately after the completion of the procedure	Survey
Length of time for analgesia	During procedure	Stopwatch
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
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