1% Lidocaine Paracervical Block for Endometrial Biopsy

Mount Sinai Hospital, Canada96 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Enrollment

Conditions

Endometrial Biopsy

Interventions

Lidocaine 1% Injectable SolutionDRUG

10 cc 1% lidocaine paracervical injection

Capped needleOTHER

Tapping the cervicovaginal junction with a capped needle

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

OPG

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

Global pain score

100 mm Visual Analogue Scale (VAS), minimum value 0 (no pain at all) and maximum value 100 (worst pain imaginable)

Time frame: Immediately after the completion of the procedure

Secondary Outcomes

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

Time frame: During the procedure

Immediate complications of endometrial biopsy and/or intervention/control

Provider reported

Time frame: 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)

Time frame: Immediately after the completion of the procedure

Length of time for analgesia

Stopwatch

Time frame: During procedure

Length of time for endometrial biopsy completion

Stopwatch

Time frame: During procedure

Number of passes with biopsy pipelle to collect sufficient tissue

Provider reported

Time frame: Immediately after the completion of the procedure

Amount of tissue obtained: scant, minimal, adequate

Provider reported

Data from ClinicalTrials.gov

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