EMLA Cream as Analgesic for Outpatient Gynecological Procedures

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Pain
• Intervention / Treatment: Drug: EMLA Cream; Drug: VersaPro Cream Base for Compounding

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 Type: Interventional
• Enrollment (Estimated): 400
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Dara Seybold, MAA; Phone Number: 3049326696; Email: djseybold@camc.org
• Study Contact Backup: Name: Cassidy Crews, MPH; Email: cassidy.crews@camc.org

Study Locations

• United States
  • West Virginia
    • Charleston, West Virginia, United States, 25302
      • Charleston Area Medical Center Institute for Academic Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: EMLA Cream; 5 grams will be applied to patient's cervix 7 minutes before gynecological procedure	Drug: EMLA Cream; Eutectic Mixture of Local Anesthetics (Lidocaine 2.5% and Prilocaine 2.5%)
Placebo Comparator: VersaPro Cream; 5 grams will be applied to patient's cervix 7 minutes before gynecological procedure	Drug: VersaPro Cream Base for Compounding; Placebo

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: CAMC Health System
• Investigators: Principal Investigator: Alex Poulsen, DO, West Virginia School of Medicine--Charleston Division

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2023
• Primary Completion (Estimated): February 28, 2024
• Study Completion (Estimated): February 28, 2024

Study Registration Dates

• First Submitted: July 7, 2023
• First Submitted That Met QC Criteria: July 24, 2023
• First Posted (Actual): August 1, 2023

Study Record Updates

• Last Update Posted (Estimated): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 13, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: hysteroscopy; endometrial biopsy; intra-uterine device insertion
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Anesthetics, Combined; Lidocaine, Prilocaine Drug Combination
• Other Study ID Numbers: 22-910

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes