1% Lidocaine Paracervical Block for Endometrial Biopsy

Mount Sinai Hospital, Canada

Status: Not yet enrolling

Conditions: Endometrial Biopsy

Treatments: Drug: Saline; 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 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.

Enrollment: 174 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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174 participants in 3 patient groups, including a placebo group

1% lidocaine paracervical injection

Experimental group

Description:

10 cc 1% lidocaine with epinephrine paracervical injection

Treatment:

Drug: Lidocaine 1% Injectable Solution

normal saline paracervical injection

Placebo Comparator group

Description:

10 cc normal saline paracervical injection

Treatment:

Drug: Saline

control

Sham Comparator group

Description:

gently tapping the cervicovaginal junction with a capped needle

Treatment:

Other: Capped needle