Topical Lidocaine vs. Traditional Management in Manual Vacuum Aspiration Pain Management.

Launched by RICARDO A GUTIERREZ RAMIREZ, MD, MSC, FACOG · Jan 16, 2025

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