400 Participants Needed

EMLA Cream for Pain Management During Gynecological Procedures

DS
CC
Overseen ByCassidy Crews, MPH
Age: 18+
Sex: Female
Trial Phase: Phase 4
Sponsor: CAMC Health System
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to compare pain perception in the study participant population undergoing the following gynecological procedures: Intra Uterine Device (IUD) insertion, hysteroscopy, and endometrial biopsy and given either Eutectic Mixture of Local Anesthetics (EMLA) cream or a placebo. The main question to answer is: • Does EMLA cream reduce pain when administered during the following gynecological procedures: IUD insertion, hysteroscopy, and endometrial biopsy? Participants will be asked to do assess their pain on the Visual Analogue Scale through 3 times during the procedure. Researchers will compare the study group with those receiving placebo group to see if there is a difference in pain scores.

Research Team

AP

Alex Poulsen, DO

Principal Investigator

West Virginia School of Medicine--Charleston Division

Eligibility Criteria

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

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

Treatment Details

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.
Participant Groups
2Treatment groups
Active Control
Placebo Group
Group I: EMLA CreamActive Control1 Intervention
5 grams will be applied to patient's cervix 7 minutes before gynecological procedure
Group II: VersaPro CreamPlacebo Group1 Intervention
5 grams will be applied to patient's cervix 7 minutes before gynecological procedure

Find a Clinic Near You

Who Is Running the Clinical Trial?

CAMC Health System

Lead Sponsor

Trials
47
Recruited
8,000+
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