Endometrial Biopsy
Conditions
Keywords
lidocaine
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.
Interventions
10 cc 1% lidocaine paracervical injection
OTHERCapped needle
Tapping the cervicovaginal junction with a capped needle
Sponsors
Mount Sinai Hospital, Canada
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
The investigators will employ a two provider system to ensure a double-blinded set-up. The first provider (Provider A) will open the allocation envelopes without the presence of the participant or second provider (Provider B). Provider A will then enter the patient's room and introduce themselves. Provider A will place the speculum, and administer either the intervention or control and then leave the room after injection-related bleeding has stopped. After 3 minutes, the second provider (Provider B) will enter the room to place the tenaculum and perform the endometrial biopsy and will be unaware of the participant's treatment arm. A standardized script will be used with all participants: "You may or not may feel a poke." Both lidocaine and the control are odorless and clear, minimizing the risk of unblinding. All data will remain blinded until data analysis.
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Global pain score | 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
| Measure | Time frame | Description |
|---|---|---|
| Pain scores during procedure | During the 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 |
| Immediate complications of endometrial biopsy and/or intervention/control | Immediately after the completion of the procedure | Provider reported |
| Difficulty for provider to complete the biopsy | Immediately after the completion of the procedure | Provider reported on Likert scale, minimum 1 (least difficult) and maximum 5 (most difficult) |
| Length of time for analgesia | During procedure | Stopwatch |
| Length of time for endometrial biopsy completion | During procedure | Stopwatch |
| Number of passes with biopsy pipelle to collect sufficient tissue | Immediately after the completion of the procedure | Provider reported |
| Amount of tissue obtained: scant, minimal, adequate | Immediately after the completion of the procedure | Provider reported |
| Patient satisfaction | Immediately after the completion of the procedure | Survey |
Countries
Canada
Outcome results
None listed