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

NCT06784024 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2025-08-26

No results posted yet for this study

Summary

The main objective of this study is to evaluate the effect of lidocaine versus placebo according to the visual analog pain scale, during manual uterine aspiration in patients with endometrial thickening, by means of a prospective, randomized, double-blind, placebo-controlled clinical trial, taking into account women with a diagnosis of endometrial thickening, requiring MVA, which will be performed in the emergency area of Obstetrics and Gynecology of the Hospital Materno Infantil, by resident physicians of the second year of the residency of said postgraduate course supervised by specialist physicians. A sample of 126 participants will be studied, divided into 2 groups of 63 patients each (control and intervention), the first group will be given placebo and the second group will be given lidocaine 10%, 20 sprays, in addition to the pre-established pain management for MVA, and the pain perception before, during and after the procedure will be evaluated by means of the visual analog pain scale. The data will be tabulated and analyzed in Redcap (software) using descriptive statistics.

Conditions

  • Endometrial Hyperplasia
  • Endometrial Diseases

Interventions

DRUG

Lidocaine topical

Topical lidocaine (SPRAY SOLUTION 10 g) 10% will be applied to the cervix and cervical canal prior to the MVA procedure in a number of 20 sprays separated by 3 seconds between each spray (0.06 ml/spray).

OTHER

Saline solution

Placebo (0.9% saline) will be applied topically to the cervix and cervical canal prior to the MVA procedure in a number of 20 sprays separated by 3 seconds between each spray (0.06 ml / spray).

Sponsors & Collaborators

  • Ricardo A Gutierrez Ramirez, MD, MSc, FACOG

    lead OTHER

Principal Investigators

  • Ricardo A Gutierrez Ramirez, MD, MSc · Universidad Nacional Autonoma de Honduras

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-15
Primary Completion
2025-07-01
Completion
2025-08-20

Countries

  • Honduras

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06784024 on ClinicalTrials.gov