EMLA Cream as Analgesic for Outpatient Gynecological Procedures
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- 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
- Visual Analogue Scale Pain Score 3 [2 minutes after speculum removal]
Scale of 0-10 on a self-reported pain score
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Charleston Area Medical Center Institute for Academic Medicine | Charleston | West Virginia | United States | 25302 |
Sponsors and Collaborators
- CAMC Health System
Investigators
- Principal Investigator: Alex Poulsen, DO, West Virginia School of Medicine--Charleston Division
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 22-910