Topical Lidocaine vs. Traditional Management in Manual Vacuum Aspiration Pain Management.
Launched by RICARDO A GUTIERREZ RAMIREZ, MD, MSC, FACOG · Jan 16, 2025
Trial Information
Current as of July 24, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating whether a topical lidocaine spray can help reduce pain during a procedure called manual vacuum aspiration (MVA) for women with thickened endometrial tissue. The study involves two groups of women—one group will receive the lidocaine spray, while the other group will get a placebo (a treatment that has no active ingredient) in addition to standard pain management. Researchers will measure pain levels before, during, and after the procedure using a simple pain scale.
To participate, women must be over 40 years old, in good health, and diagnosed with endometrial thickening or abnormal uterine bleeding. They should be able to give consent and are required to complete certain health checks, including a specific ultrasound result. The trial is currently recruiting participants, and women who join can expect to receive care from trained resident doctors supervised by specialists in a hospital setting. It's important to note that women who are pregnant, breastfeeding, or have certain health conditions are not eligible to take part in this study.
Gender
FEMALE
Eligibility criteria
- Inclusion Criteria:
- • Be in good general health, as evidenced by your medical history, or have been diagnosed with endometrial thickening or have abnormal uterine bleeding.
- • Ultrasonography with endometrial line greater than 5 mm
- • Normotensive
- • Over 40 years of age
- • Able to give informed consent to participate in the study.
- • Cervical dilatation \> 2 mm
- • Cervical dilatation \< 10 mm
- • Patient without hemodynamic decompensation.
- • Submission of a signed and dated informed consent form.
- • Declared willingness to comply with all study procedures and availability for the duration of the study.
- • Menopausal woman.
- • Willingness to comply with the protocol regimen.
- • Possess a cell phone.
- • Ability to read.
- • Know how to write.
- • To reside in Francisco Morazán.
- Exclusion Criteria:
- • Pregnant or breastfeeding women.
- • Patients with severe cardiovascular diseases.
- • Presence of active gynecological infections.
- • History of severe adverse reactions to lidocaine.
- • Acute pelvic pain.
- • Mental disability preventing informed consent.
- • Hemodynamic decompensation
About Ricardo A Gutierrez Ramirez, Md, Msc, Facog
Dr. Ricardo A. Gutierrez Ramirez, MD, MSc, FACOG, is a distinguished clinical trial sponsor and expert in the field of obstetrics and gynecology. With advanced degrees and board certification, he brings a wealth of knowledge and experience in conducting clinical research aimed at improving women's health outcomes. Dr. Gutierrez Ramirez is committed to advancing medical science through rigorous study design, ethical practices, and innovative methodologies, ensuring high-quality data that contribute to the development of effective treatments and interventions. His dedication to patient safety and scientific integrity positions him as a leading figure in clinical research.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Tegucigalpa, Francisco Morazan, Honduras
Patients applied
Trial Officials
Ricardo A Gutierrez Ramirez, MD, MSc
Study Director
Universidad Nacional Autonoma de Honduras
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported