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

NCT06784024 | Completed DMC

• 1 other identifier: PGO-UNAH-48-1-2025
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Lidocaine; manual vacuum aspiration; Pain management

Outcome Measures

Primary Outcomes (1)

• Visual Analog Pain Scale

  It is a horizontal line of 10 centimeters, at the ends of which the extreme expressions of a symptom are shown. On the left side is located the absence or lower intensity and on the right side the higher intensity. The patient is then asked to mark on the line the point indicating the intensity and it is measured with a millimeter ruler. The intensity is expressed in centimeters or millimeters. The scale will be measured at 5 times: During the administration of injectable lidocaine During the placement of the Pozzi clamp During the introduction of the cannula 120 seconds after starting the procedure 2 hours after starting the procedure

  Since intervention until 2 hours

Secondary Outcomes (1)

• Adverse effects of lidocaine

  Since intervention until 24 hours

Study Arms (2)

Lidocaine

EXPERIMENTAL

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).

Drug: Lidocaine topical

Control

PLACEBO COMPARATOR

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).

Other: Saline solution

Interventions

Lidocaine topical DRUG

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).

Also known as: Lidocaine

Lidocaine

Saline solution OTHER

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).

Also known as: SSN 0.9%

Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ricardo A Gutierrez Ramirez, MD, MSc, FACOG: lead

Study Sites (1)

Hospital Escuela

Tegucigalpa, Francisco Morazán Department, 11101, Honduras

Location

Related Publications (1)

• Charoenkwan K, Nantasupha C. Methods of pain control during endometrial biopsy: A systematic review and meta-analysis of randomized controlled trials. J Obstet Gynaecol Res. 2020 Jan;46(1):9-30. doi: 10.1111/jog.14152. Epub 2019 Oct 30.

  PMID: 31667985 BACKGROUND

MeSH Terms

Conditions

Endometrial Hyperplasia; Uterine Diseases; Agnosia

Interventions

Lidocaine; Saline Solution

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Ricardo A Gutierrez Ramirez, MD, MSc

  Universidad Nacional Autonoma de Honduras

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Randomization ensures that participants are equally distributed between treatment groups (topical lidocaine and placebo), which minimizes selection bias and confounding. This allows observed differences in outcomes to be attributed to treatment rather than other variables. \- Double Blind: Keeping both participants and investigators uninformed regarding the treatment group eliminates observer bias and patient expectation bias. This is crucial for obtaining valid and objective results on the effectiveness of topical lidocaine in pain management.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Titular professor

Model Details: randomized, double-blind, placebo-controlled, parallel-group (Group A and Group B) clinical trial of superiority and efficacy.

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 20, 2025
• Study Start: January 15, 2025
• Primary Completion: July 1, 2025
• Study Completion: August 20, 2025
• Last Updated: August 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

HO (1)