Comparing Lidocaine and Placebo for Pain Relief During Manual Vacuum Aspiration
Topical Lidocaine vs. Traditional Management in Manual Vacuum Aspiration Pain Management, for Endometrial Thickness. Randomized Double-blind Clinical Trial.
NA · Universidad Nacional Autonoma de Honduras · NCT06784024
This study is testing if a numbing cream called lidocaine can help reduce pain for women having a manual vacuum aspiration procedure compared to a placebo.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 126 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Female |
| Sponsor | Universidad Nacional Autonoma de Honduras (other) |
| Locations | 1 site (Tegucigalpa, Francisco Morazan) |
| Trial ID | NCT06784024 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of topical lidocaine compared to a placebo in managing pain during manual vacuum aspiration (MVA) for patients with endometrial thickening. It is a prospective, randomized, double-blind, placebo-controlled trial involving 126 participants, divided into two groups. The study will assess pain perception using a visual analog pain scale before, during, and after the MVA procedure, which is performed in the emergency area of Obstetrics and Gynecology. The trial aims to improve pain management protocols for women undergoing this common procedure.
Who should consider this trial
Good fit: Ideal candidates include women over 40 years old with endometrial thickening or abnormal uterine bleeding who can provide informed consent.
Not a fit: Patients who are pregnant, breastfeeding, or have severe cardiovascular diseases will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for women undergoing manual vacuum aspiration.
How similar studies have performed: Previous studies have shown the effectiveness of lidocaine in pain management during similar procedures, suggesting a positive outlook for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Tegucigalpa, Francisco Morazan
- Hospital Escuela — Tegucigalpa, Francisco Morazan, Honduras (RECRUITING)
Study contacts
- Study coordinator: Ricardo A. Gutierrez Ramirez, MD, MSc
- Email: ricardo.gutierrez@unah.edu.hn
- Phone: 50497546940
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Endometrial Hyperplasia, Endometrial Diseases, Lidocaine, manual vacuum aspiration, Pain management