Clinical trial NCT06546254: 1% Lidocaine Paracervical Block for Endometrial Biopsy
Official title: A Double-blind Randomized Controlled Trial of 1% Lidocaine Paracervical Block for Endometrial Biopsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Endometrial Biopsy
Keywords: lidocaine
Lead sponsor: Mount Sinai Hospital, Canada
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 96
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The proposed study is a double-blind randomized controlled trial. Participants will be recruited from Mount Sinai Hospital outpatient gynecology clinics. Recruitment, consent, randomization, procedure, and post-procedure survey will occur during the same visit. Each participant will be randomly assigned to one of two arms:

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.
Primary purpose: OTHER

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.


Eligibility 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)

Primary outcomes:
measure: Global pain score
timeFrame: Immediately after the completion of the procedure
Secondary outcomes:
measure: Pain scores during procedure
timeFrame: During the procedure
measure: Immediate complications of endometrial biopsy and/or intervention/control
timeFrame: Immediately after the completion of the procedure
measure: Difficulty for provider to complete the biopsy
timeFrame: Immediately after the completion of the procedure
measure: Length of time for analgesia
timeFrame: During procedure
measure: Length of time for endometrial biopsy completion
timeFrame: During procedure
measure: Number of passes with biopsy pipelle to collect sufficient tissue
timeFrame: Immediately after the completion of the procedure
measure: Amount of tissue obtained: scant, minimal, adequate
timeFrame: Immediately after the completion of the procedure
measure: Patient satisfaction
timeFrame: Immediately after the completion of the procedure
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: OPG
state: Ontario
Study officials:
References: