EMLA Cream as Analgesic for Outpatient Gynecological Procedures

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pain

Intervention / Treatment
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* Drug: EMLA Cream
* Drug: VersaPro Cream Base for Compounding


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intra-uterine device insertion, hysteroscopy, endometrial biopsy