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?

This trial tests whether a lidocaine injection can reduce pain during an endometrial biopsy, a procedure that involves taking a small tissue sample from the lining of the uterus. Participants will receive either a lidocaine injection or a gentle tap at the procedure site as a control. The trial aims to determine if the lidocaine injection reduces discomfort compared to no real intervention. It is suitable for English-speaking individuals over 18 who are scheduled for an endometrial biopsy and have not recently used strong painkillers or have chronic pain conditions. As an unphased trial, this study offers participants the chance to contribute to research that could enhance comfort during medical procedures.

Will I have to stop taking my current medications?

You may need to stop taking certain pain medications like opioids or benzodiazepines 24 hours before the trial. However, NSAIDs and acetaminophen are allowed.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using lidocaine for procedures like an endometrial biopsy is generally safe. In past studies, no negative effects were reported with lidocaine use. For instance, one study with 140 patients found that a paracervical block with lidocaine significantly reduced pain without any side effects.

These results suggest that lidocaine is well-tolerated for procedures similar to an endometrial biopsy. This safety record can reassure those considering joining a trial that uses lidocaine. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for discomfort during endometrial biopsy, which typically involves oral pain relievers or topical anesthetics, the use of 1% lidocaine with epinephrine offers a more direct pain management approach. This treatment is administered via a paracervical injection, delivering the anesthetic right where it's needed, potentially offering quicker and more effective pain relief. Researchers are excited about this method because it could provide targeted relief with minimal systemic absorption, reducing overall discomfort and improving patient experience during the procedure.

What evidence suggests that 1% lidocaine might be an effective treatment for reducing pain during endometrial biopsy?

Research has shown that lidocaine can reduce pain during an endometrial biopsy. In this trial, one group of participants will receive a paracervical injection of 1% lidocaine with epinephrine. Studies indicate this method significantly lessens pain compared to no treatment. One study found it more effective than oral painkillers. By targeting the area around the cervix, this approach better manages pain during the procedure. While some studies focus on using lidocaine inside the uterus, the paracervical method still promises to make the biopsy experience more comfortable. ^{2 3 4 6 7}

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3939147/

Comparison of the efficacy of intrauterine lidocaine ... Intrauterine lidocaine anesthesia technique decreases pain in endometrial sampling with pipelle more efficiently than paracervical block or oral etodolac.

2. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/10.1111/jog.16148

Optimizing analgesia for endometrial biopsy: A prospective ... Intrauterine lidocaine and paracervical block are more effective than lidocaine spray and oral dexketoprofen in reducing procedural pain during EMB.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0029784499005578

Anesthetic efficacy of intrauterine lidocaine for endometrial ... 01). Conclusion: Intrauterine lidocaine is simple and effective for decreasing pain associated with the Pipelle endometrial biopsy.

4. journals.lww.com journals.lww.com/greenjournal/fulltext/2000/03000/anesthetic_efficacy_of_intrauterine_lidocaine_for.6.aspx

Anesthetic Efficacy of Intrauterine Lidocaine for... Intrauterine instillation of lidocaine before endometrial biopsy resulted in significant reduction of median (range) pain scale responses compared with placebo ...

5. acog.org acog.org/clinical/clinical-guidance/clinical-consensus/articles/2025/05/pain-management-for-in-office-uterine-and-cervical-procedures

Pain Management for In-Office Uterine and Cervical ... An RTC of 140 patients demonstrated significant pain reduction with the use of a paracervical block with divided dosing injections of 20 mL 1% ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3493155/

Intrauterine Anesthesia for Gynecologic Procedures No studies included in this review reported any adverse outcomes. One study has clearly demonstrated that the use of intrauterine lidocaine does not impact the ...

7. withpower.com withpower.com/trial/phase-endometrial-biopsy-7-2024-8d2f5

Lidocaine for Endometrial Biopsy The objective of this study is to to determine whether 1% lidocaine paracervical block reduces pain during endometrial biopsy in comparison to no intervention.