EMLA Cream as Analgesic for Outpatient Gynecological Procedures

Phase 4

• Conditions: Pain
• Interventions: Drug: EMLA Cream; Drug: VersaPro Cream Base for Compounding

• Registration Number: NCT05970354
• Lead Sponsor: CAMC Health System

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-07-07
• Study First Submitted QC: 2023-07-24
• Study First Posted: 2023-08-01
• Study Start: 2023-09-15
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-31
• Last Update Posted: 2024-08-01
• Primary Completion: 2024-12-31
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EMLA Cream	EMLA Cream	5 grams will be applied to patient's cervix 7 minutes before gynecological procedure
VersaPro Cream	VersaPro Cream Base for Compounding	5 grams will be applied to patient's cervix 7 minutes before gynecological procedure

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale Pain Score 3	2 minutes after speculum removal	Scale of 0-10 on a self-reported pain score
Visual Analogue Scale Pain Score 1	At time of speculum placement for procedure	Scale of 0-10 on a self-reported pain score
Visual Analogue Scale Pain Score 2	At start of cervical manipulation	Scale of 0-10 on a self-reported pain score

Trial Locations

Locations (1)

Charleston Area Medical Center Institute for Academic Medicine; 🇺🇸 Charleston, West Virginia, United States