A Double-blind Randomized Controlled Trial of 1% Lidocaine Paracervical Block for Endometrial Biopsy
Overview
- Phase
- Not Applicable
- Intervention
- Lidocaine 1% Injectable Solution
- Conditions
- Endometrial Biopsy
- Sponsor
- Mount Sinai Hospital, Canada
- Enrollment
- 96
- Locations
- 1
- Primary Endpoint
- Global pain score
- Status
- Completed
- Last Updated
- 3 months ago
Overview
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:
- intervention (paracervical block - 10 mL 1% lidocaine with epinephrine)
- 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.
Investigators
Mara Sobel
Prinicipal Investigator (Dr.)
Mount Sinai Hospital, Canada
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)
Arms & Interventions
1% lidocaine paracervical injection
10 cc 1% lidocaine with epinephrine paracervical injection
Intervention: Lidocaine 1% Injectable Solution
control
gently tapping the cervicovaginal junction with a capped needle
Intervention: Capped needle
Outcomes
Primary Outcomes
Global pain score
Time Frame: 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 Outcomes
- Immediate complications of endometrial biopsy and/or intervention/control(Immediately after the completion of the procedure)
- Difficulty for provider to complete the biopsy(Immediately after the completion of the procedure)
- Patient satisfaction(Immediately after the completion of the procedure)
- Length of time for endometrial biopsy completion(During procedure)
- Length of time for analgesia(During procedure)
- Number of passes with biopsy pipelle to collect sufficient tissue(Immediately after the completion of the procedure)
- Amount of tissue obtained: scant, minimal, adequate(Immediately after the completion of the procedure)
- Pain scores during procedure(During the procedure)