EMLA Cream for Pain Management During Gynecological Procedures

Overseen By Cassidy Crews, MPH

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: CAMC Health System

Disqualifiers: Hypersensitivity to amide anesthetics, methemoglobinemia

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: Single visit

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether EMLA cream, a topical anesthetic, can reduce pain during certain gynecological procedures such as IUD insertion, hysteroscopy, and endometrial biopsy. Participants will receive either the EMLA cream or a placebo to determine any differences in reported pain levels. This trial suits individuals scheduled for these procedures who wish to potentially ease their discomfort. As a Phase 4 trial, EMLA cream is already FDA-approved and proven effective, and this research aims to understand how it benefits more patients.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for EMLA Cream?

Research has shown that EMLA Cream, containing lidocaine and prilocaine, is usually well-tolerated by patients. Studies confirm its safety for skin application. However, its effectiveness in managing pain during surgeries is sometimes questioned. Data from 121 patients indicated that EMLA Cream might not be very effective as the sole pain reliever in surgeries. While information on its safety for specific procedures like skin peels is limited, EMLA Cream's FDA approval for certain uses suggests it is safe when used as directed. Participants in clinical trials can feel reassured about the safety of EMLA Cream based on its FDA approval and existing research. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

EMLA Cream is unique because it offers a topical solution for managing pain during gynecological procedures, unlike the standard options like oral painkillers or injectable anesthetics. Its active ingredients, lidocaine and prilocaine, work together to numb the area quickly and effectively, potentially reducing the need for more invasive pain management techniques. Researchers are excited about EMLA Cream because it can be applied directly to the cervix just minutes before the procedure, offering a fast-acting and non-invasive alternative to traditional pain management methods.

What evidence suggests that EMLA cream might be an effective treatment for pain management during gynecological procedures?

Research has shown that EMLA cream, a mix of lidocaine and prilocaine, reduces pain during certain medical procedures. In this trial, participants will receive either EMLA cream or a placebo cream before their gynecological procedure. Studies have found that applying EMLA cream on the cervix significantly decreases pain during procedures like hysteroscopy and cervical manipulation. Specifically, one study showed that EMLA cream lowered pain during tenaculum placement and uterine measurement, clearly reducing discomfort. Another study found that applying it before vaginal exams significantly eased pain for postmenopausal women. These findings suggest that EMLA cream effectively manages pain during various gynecological procedures. ^{4 6 7 8 9}

Who Is on the Research Team?

Alex Poulsen, DO

Principal Investigator

West Virginia School of Medicine--Charleston Division

Are You a Good Fit for This Trial?

This trial is for patients undergoing certain gynecological procedures: IUD insertion, hysteroscopy, or endometrial biopsy. It's not suitable for those with allergies to amide anesthetics or who have a condition called methemoglobinemia.

Inclusion Criteria

I am scheduled for a procedure related to my uterus, such as IUD insertion, hysteroscopy, or an endometrial biopsy.

Exclusion Criteria

You are allergic to certain types of anesthesia called amide anesthetics.

I have a condition that affects my blood's oxygen-carrying capacity.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either EMLA cream or placebo applied to the cervix 7 minutes before gynecological procedures

Single visit

1 visit (in-person)

Follow-up

Participants are monitored for pain perception using the Visual Analogue Scale during and after the procedure

Immediate post-procedure

What Are the Treatments Tested in This Trial?

Interventions

• EMLA Cream

Trial Overview The study tests if EMLA Cream (a local anesthetic) reduces pain compared to a placebo during specific outpatient gynecological procedures. Participants will rate their pain at different times using the Visual Analogue Scale.

How Is the Trial Designed?

Group I: EMLA Cream Active Control 1 Intervention

5 grams will be applied to patient's cervix 7 minutes before gynecological procedure

Group II: VersaPro Cream Placebo Group 1 Intervention

5 grams will be applied to patient's cervix 7 minutes before gynecological procedure

Who Is Running the Clinical Trial?

CAMC Health System

Lead Sponsor

Trials

47

Recruited

8,000+

Citations

1. 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 ... However, data support that cervical application of 5% lidocaine–prilocaine cream reduces pain associated with cervical instrumentation of ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S030121151400517X

Lidocaine–prilocaine cream as analgesia for ... Endocervical and exocervical topical application of EMLA 10 min before performing hysterosalpingography significantly reduced pain during cervical manipulation ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4930450/

Comparison of the Effects of Lidocaine Prilocaine Cream ... Conclusion: The findings of this study showed that the use of EMLA cream in the site of episiotomy incision in primiparous women can induce a level of analgesia ...

4. ebwhj.journals.ekb.eg ebwhj.journals.ekb.eg/article_391649_bf7d02c24e61e5cd952e0ffbc254485f.pdf

Efficacy and Safety of EMLA Cream in Reducing Pain ... EMLA cream significantly lowered pain at tenaculum placement(MD= -1.68, 95% CI [-2.5, -0.86], p <0.0001), uterine sounding(MD= -1.8, 95% CI[-2.51, -1.08], p < ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1553465012000064

Topical Anesthetic (Lidocaine-Prilocaine) Cream ... Topical application of EMLA 5% cream on genital mucosa of postmenopausal women before vaginal examination significantly reduces pain associated with speculum ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2018/019941s021lbl.pdf

EMLA CREAM (lidocaine 2.5% and Prilocaine 2.5%) The data from 121 patients demonstrated that EMLA Cream was not effective as a sole anesthetic agent in managing the pain from the surgical procedure.

7. medsafe.govt.nz medsafe.govt.nz/profs/datasheet/e/Emlacream.pdf

emla cream 5% emla patch Clinical trial data on the safety and efficacy of EMLA use in dermal peels is limited and. EMLA should be used with caution in these cases. Page 5. EMLA Data ...

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2000/19941s11lbl.pdf

EMLA - accessdata.fda.gov The data from 121 patients demonstrated that EMLA Cream was not effective as a sole anesthetic agent in managing the pain from the surgical procedure.

9. medicines.org.uk medicines.org.uk/emc/product/871/smpc

EMLA Cream 5% (5g pack) 110. 5.3 Preclinical safety data. In animal studies the toxicity noted after high doses of either lidocaine or prilocaine, alone or in combination, consisted ...