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1% Lidocaine Paracervical Block for Endometrial Biopsy

Mount Sinai Hospital, Canada logo

Mount Sinai Hospital, Canada

Status

Enrolling

Conditions

Endometrial Biopsy

Treatments

Other: Capped needle
Drug: Lidocaine 1% Injectable Solution

Study type

Interventional

Funder types

Other

Identifiers

NCT06546254
REB 23-0078-A

Details and patient eligibility

About

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.

Enrollment

96 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

96 participants in 2 patient groups

1% lidocaine paracervical injection
Experimental group
Description:
10 cc 1% lidocaine with epinephrine paracervical injection
Treatment:
Drug: Lidocaine 1% Injectable Solution
control
Sham Comparator group
Description:
gently tapping the cervicovaginal junction with a capped needle
Treatment:
Other: Capped needle

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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