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Enrolling by Invitation

NCT Number: NCT05970354

EMLA Cream as Analgesic for Outpatient Gynecological Procedures

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Charleston Area Medical Center Institute for Academic Medicine

Charleston, West Virginia, 25302, United States

About this study

Gynecologic outpatient procedures such as intra-uterine device (IUD) insertion, hysteroscopy and endometrial biopsies (EMB) have no standard of care for pain management. This has resulted in acute pain for patients. One local anesthetic, Eutectic Mixture of Local Anesthetics (EMLA) cream (Lidocaine 2.5%/Prilocaine 2.5%), has shown to decrease perceived pain during hysteroscopy and IUD placement when compared to a placebo. The purpose of this study is to evaluate whether EMLA cream reduces pain during the following outpatient procedures: EMB, hysteroscopy, and IUD placement. Through a randomized control double-blind trial, study participants will have either 5 grams of EMLA cream or 5 grams of placebo applied to their cervix 7 minutes prior to the procedure. Patients' intensity of pain will be assessed using the Visual Analogue Scale (VAS) immediately after speculum placement, during the procedure, and immediately after completion of the procedure. Pain scores will be compared between the study and placebo group.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient will undergo one of the following procedures: intra-uterine device insertion, hysteroscopy, or endometrial biopsies

Exclusion criteria

  • Known hypersensitivity to amide anesthetics
  • Pre-existing methemoglobinemia

Treatment and study plan

EMLA cream

Drug

Eutectic Mixture of Local Anesthetics (Lidocaine 2.5% and Prilocaine 2.5%)

VersaPro Cream Base for Compounding

Drug

Placebo

Primary outcomes

  1. Visual Analogue Scale Pain Score 1

    Time frame: At time of speculum placement for procedure

    Scale of 0-10 on a self-reported pain score

  2. Visual Analogue Scale Pain Score 2

    Time frame: At start of cervical manipulation

    Scale of 0-10 on a self-reported pain score

  3. Visual Analogue Scale Pain Score 3

    Time frame: 2 minutes after speculum removal

    Scale of 0-10 on a self-reported pain score

Sponsors and collaborators

Lead sponsor

CAMC Health System

Other

Registry information

Official study title

Lidocaine-Prilocaine Cream as Analgesic for Outpatient Gynecological Procedures; A Randomized-Control Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Aug 1, 2023
Registry last updated
Aug 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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