EMLA Cream as Analgesic for Outpatient Gynecological Procedures

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05970354
• Other study ID #: 22-910
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: September 15, 2023
• Est. completion date: February 28, 2024

Study information

• Verified date: November 2023
• Source: CAMC Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 400
• Est. completion date: February 28, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• EMLA Cream
Eutectic Mixture of Local Anesthetics (Lidocaine 2.5% and Prilocaine 2.5%)
• VersaPro Cream Base for Compounding
Placebo

Locations

Country	Name	City	State
United States	Charleston Area Medical Center Institute for Academic Medicine	Charleston	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
CAMC Health System

Country where clinical trial is conducted

United States, 

Outcome

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