EMLA Cream as Analgesic for Outpatient Gynecological Procedures

NCT ID: NCT05970354

Last Updated: 2024-08-01

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE4
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-15
• Study Completion Date: 2025-02-28

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

EMLA Cream

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

Group Type: ACTIVE_COMPARATOR

EMLA Cream

Intervention Type: DRUG

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

VersaPro Cream

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

Group Type: PLACEBO_COMPARATOR

VersaPro Cream Base for Compounding

Intervention Type: DRUG

Placebo

Interventions

EMLA Cream

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

Intervention Type: DRUG

VersaPro Cream Base for Compounding

Placebo

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

CAMC Health System

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alex Poulsen, DO

Role: PRINCIPAL_INVESTIGATOR

West Virginia School of Medicine--Charleston Division

Locations

Charleston Area Medical Center Institute for Academic Medicine

Charleston, West Virginia, United States

Countries

United States

Other Identifiers

22-910

Identifier Type: -

Identifier Source: org_study_id