Lidocaine for Endometrial Biopsy

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Mount Sinai Hospital, Canada

Must not be taking: Opioids, Benzos, Misoprostol, others

Disqualifiers: Pregnancy, Chronic pain syndromes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

96 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for English-speaking individuals who need an endometrial biopsy. It's open to people of all parities, meaning it doesn't matter if they've had children before or not.

Inclusion Criteria

This criterion does not apply to me.

I speak English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo endometrial biopsy with either a paracervical block or a control procedure

1 day

1 visit (in-person)

Follow-up

Participants are monitored for immediate complications and pain scores are recorded

Immediately after the procedure

What Are the Treatments Tested in This Trial?

Interventions

• 1% Lidocaine

Trial Overview The study tests if a painkiller called lidocaine can reduce pain during the biopsy compared to no pain relief. Participants are randomly placed in two groups: one gets a lidocaine shot near the cervix, and the other just feels a tap with a capped needle.

How Is the Trial Designed?

Group I: 1% lidocaine paracervical injection Experimental Treatment 1 Intervention

10 cc 1% lidocaine with epinephrine paracervical injection

Group II: control Placebo Group 1 Intervention

gently tapping the cervicovaginal junction with a capped needle

Who Is Running the Clinical Trial?

Mount Sinai Hospital, Canada

Lead Sponsor

Trials

210

Recruited

70,700+