Endometrial HyperplasiaENDOLIDNCT06784024
Topical Lidocaine vs. Traditional Management in Manual Vacuum Aspiration Pain Management.
A study testing Lidocaine topical and Saline solution in people with Endometrial Hyperplasia and Endometrial Diseases, run by Ricardo A Gutierrez Ramirez, MD, MSc, FACOG at 1 site in Honduras.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometrial Hyperplasia, Endometrial Diseases
- What is being tested?
- Lidocaine topical and Saline solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 129 participants
- Where
- 1 siteHonduras
- Study dates
- 15 Jan 2025to 20 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 16Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Honduras1 site
Hospital Escuela
Tegucigalpa, Francisco Morazán Department, 11101
About this study
Official title: Topical Lidocaine vs. Traditional Management in Manual Vacuum Aspiration Pain Management, for Endometrial Thickness. Randomized Double-blind Clinical Trial.
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.
Read the detailed description
The Manual Vacuum Aspiration (MVA) procedure consists of extracting residual or retained tissues from the uterine cavity through a cannula connected to a portable aspirator that creates a manual vacuum. It is characterized for being simple, safe, effective and accepted by patients, since it is economical, fast and does not require hospitalization in comparison to "Instrumental Uterine Curettage".
Worldwide, abnormal uterine bleeding, endometrial thickening and abortion are considered a public health problem. These conditions put women's lives at risk and because of this, the manual vacuum aspiration technique (MVA) was developed to provide more humane care to women who come to hospitals for incomplete abortions. MVA uses flexible plastic hoses (Karman) of various sizes (4 to 12 mm). It can be adapted to the woman's needs, eliminating the need to dilate the cervix.
Among the important points to consider for the performance of this protocol is pain management, which, in a standardized way, is treated with paracervical block with local anesthesia, which is an effective method for pain management and should be part of all vacuum aspiration procedures. This, considering that about 97% of women who undergo it report pain during and after the procedure. Therefore, non-steroidal anti-inflammatory drugs are also widely used 30 minutes prior to the procedure.
In a Swedish study of 200 patients who underwent MVA for incomplete abortion and uterine size less than eight weeks gestation, patients were allowed to choose between general anesthesia or paracervical block. Of the 37 patients who chose MVA with paracervical block, none requested conversion to general anesthesia. Therefore, it can be deduced that there are satisfactory results with paracervical block.
Studies in Latin America have shown that Manual Vacuum Aspiration is a safe technique, clinically effective, fast, with less blood loss and less painful than LUI. Mexico and Colombia are two of the countries that use this technique the most, since it has been shown to be less associated with complications, such as uterine perforation, hemorrhage, infections and traumatic injuries that may exist in comparison with instrumental curettage. In several studies, the effectiveness of MVA has been shown to be greater than 98%.
It should be noted that MVA has proven to be a highly effective and safe procedure, even at the first level of care. Most women recover within a few hours.
In Honduras, the Women's Rights Center describes MVA as a considerable alternative to curettage, because it is safer and just as effective, without the need for general anesthesia, and can be performed in healthcare settings that are not strictly hospitals, for example, in health centers, if trained professionals are available. This allows the optimization of limited resources and a significant increase in women's access to treatment services. It is worth mentioning that the recovery period is shorter, so there is a substantial saving in the occupation of beds and hospital supplies and the time of incapacity is reduced in each patient.
MVA is considered by both the WHO and FIGO to be modern, versatile, safe and effective as long as the personnel trained in this medical technique and the correct equipment are available.
Pain management is an important aspect to consider when carrying out this procedure, which is why this study has special relevance, since, in our country, it constitutes one of the main treatment options for several gynecological-obstetric conditions, as it is a cost-effective tool that optimizes available resources. To know if there is any change when using topical lidocaine vs. placebo in a double-blind study, this, as a coadjuvant to standardized management, would significantly broaden the perspective and the knowledge we have about this practice, giving the possibility of improving the quality of the service offered by the hospital centers, by knowing the reality regarding the patient's perception of pain and being able to offer new analgesia alternatives or also, it is possible to contemplate the possibility of reducing costs in the performance of the procedure. Therefore, we consider that it would be very useful to obtain the results of this research, in addition to the fact that there are no related studies in the region.
- Conditions
- Endometrial Hyperplasia, Endometrial Diseases
- Being tested
- Lidocaine topical, Saline solution
- Keywords
- Lidocaine, manual vacuum aspiration, Pain management
- Medical subject headings
- Endometrial Hyperplasia, Uterine Diseases, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine topicalDrug
Also called Lidocaine
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).
Saline solutionOther
Also called SSN 0.9%
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Other: Saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Since intervention until 2 hours
Secondary outcomes (1)
Adverse effects of lidocaine
incidence of Adverse effects of lidocaine
Measured: Since intervention until 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start15 Jan 2025
- Primary completion1 Jul 2025
- Study completion20 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Endometrial HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, double-blind, placebo-controlled, parallel-group (Group A and Group B) clinical trial of superiority and efficacy.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ricardo A Gutierrez Ramirez, MD, MSc, FACOG
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ricardo A Gutierrez Ramirez, MD, MSc, FACOG, Universidad Nacional Autonoma de Honduras
- Investigators
- Ricardo A Gutierrez Ramirez, MD, MSc, Study director, Universidad Nacional Autonoma de Honduras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06784024
- Sponsor's protocol ID
- PGO-UNAH-48-1-2025
- Acronym
- ENDOLID
- Status last verified
- Feb 2025
- First submitted
- 13 Jan 2025
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is not necessary, none of the 18 HIPAA identifiers will be placed
Publications
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.
PubMed 31667985Ortiz Aguirre MJ, Barrientos Chinchilla AC, Leon-Velasquez M, Gutierrez-Ramirez RA. Topical lidocaine spray for reducing pain during paracervical block administration in postmenopausal women undergoing manual vacuum aspiration: A randomized trial. J Gynecol Obstet Hum Reprod. 2026 Jun;55(6):103177. doi: 10.1016/j.jogoh.2026.103177. Epub 2026 Apr 7.
PubMed 41956247
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Lidocaine vs. Traditional Management in Manual Vacuum Aspiration Pain Management, for Endometrial Thickness. Randomized Double-blind Clinical Trial.
- ClinicalTrials.gov ID
- NCT06784024
- Acronym / sponsor ID
- ENDOLID / PGO-UNAH-48-1-2025
- Conditions
- Endometrial Hyperplasia, Endometrial Diseases
- Keywords
- Lidocaine, manual vacuum aspiration, Pain management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Ricardo A Gutierrez Ramirez, MD, MSc, FACOGUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 20 Aug 2025 (actual)
- First posted
- 20 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Manual Vacuum Aspiration (MVA) procedure consists of extracting residual or retained tissues from the uterine cavity through a cannula connected to a portable aspirator that creates a manual vacuum. It is characterized for being simple, safe, effective and accepted by patients, since it is economical, fast and does not require hospitalization in comparison to "Instrumental Uterine Curettage".
Worldwide, abnormal uterine bleeding, endometrial thickening and abortion are considered a public health problem. These conditions put women's lives at risk and because of this, the manual vacuum aspiration technique (MVA) was developed to provide more humane care to women who come to hospitals for incomplete abortions. MVA uses flexible plastic hoses (Karman) of various sizes (4 to 12 mm). It can be adapted to the woman's needs, eliminating the need to dilate the cervix.
Among the important points to consider for the performance of this protocol is pain management, which, in a standardized way, is treated with paracervical block with local anesthesia, which is an effective method for pain management and should be part of all vacuum aspiration procedures. This, considering that about 97% of women who undergo it report pain during and after the procedure. Therefore, non-steroidal anti-inflammatory drugs are also widely used 30 minutes prior to the procedure.
In a Swedish study of 200 patients who underwent MVA for incomplete abortion and uterine size less than eight weeks gestation, patients were allowed to choose between general anesthesia or paracervical block. Of the 37 patients who chose MVA with paracervical block, none requested conversion to general anesthesia. Therefore, it can be deduced that there are satisfactory results with paracervical block.
Studies in Latin America have shown that Manual Vacuum Aspiration is a safe technique, clinically effective, fast, with less blood loss and less painful than LUI. Mexico and Colombia are two of the countries that use this technique the most, since it has been shown to be less associated with complications, such as uterine perforation, hemorrhage, infections and traumatic injuries that may exist in comparison with instrumental curettage. In several studies, the effectiveness of MVA has been shown to be greater than 98%.
It should be noted that MVA has proven to be a highly effective and safe procedure, even at the first level of care. Most women recover within a few hours.
In Honduras, the Women's Rights Center describes MVA as a considerable alternative to curettage, because it is safer and just as effective, without the need for general anesthesia, and can be performed in healthcare settings that are not strictly hospitals, for example, in health centers, if trained professionals are available. This allows the optimization of limited resources and a significant increase in women's access to treatment services. It is worth mentioning that the recovery period is shorter, so there is a substantial saving in the occupation of beds and hospital supplies and the time of incapacity is reduced in each patient.
MVA is considered by both the WHO and FIGO to be modern, versatile, safe and effective as long as the personnel trained in this medical technique and the correct equipment are available.
Pain management is an important aspect to consider when carrying out this procedure, which is why this study has special relevance, since, in our country, it constitutes one of the main treatment options for several gynecological-obstetric conditions, as it is a cost-effective tool that optimizes available resources. To know if there is any change when using topical lidocaine vs. placebo in a double-blind study, this, as a coadjuvant to standardized management, would significantly broaden the perspective and the knowledge we have about this practice, giving the possibility of improving the quality of the service offered by the hospital centers, by knowing the reality regarding the patient's perception of pain and being able to offer new analgesia alternatives or also, it is possible to contemplate the possibility of reducing costs in the performance of the procedure. Therefore, we consider that it would be very useful to obtain the results of this research, in addition to the fact that there are no related studies in the region.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- randomized, double-blind, placebo-controlled, parallel-group (Group A and Group B) clinical trial of superiority and efficacy.
| Arm | Type | Receives |
|---|---|---|
| Lidocaine | Experimental | Drug: Lidocaine topicalTopical 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). |
| Control | Placebo comparator | Other: Saline solutionPlacebo (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). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (7 listed)
- Pregnant or breastfeeding women.
- Patients with severe cardiovascular diseases.
- Presence of active gynecological infections.
- History of severe adverse reactions to lidocaine.
- Acute pelvic pain.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine topicalAlso: LidocaineTopical 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 |
| Saline solutionAlso: SSN 0.9%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 | Control |
Primary outcome
Visual Analog Pain Scale
Time frame: Since intervention until 2 hours
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
1 secondary outcome
Adverse effects of lidocaine
Time frame: Since intervention until 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Background: PubMed 31667985Charoenkwan 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.
- Derived from this study: PubMed 41956247Ortiz Aguirre MJ, Barrientos Chinchilla AC, Leon-Velasquez M, Gutierrez-Ramirez RA. Topical lidocaine spray for reducing pain during paracervical block administration in postmenopausal women undergoing manual vacuum aspiration: A randomized trial. J Gynecol Obstet Hum Reprod. 2026 Jun;55(6):103177. doi: 10.1016/j.jogoh.2026.103177. Epub 2026 Apr 7.
- Individual participant dataSharing planned: No. It is not necessary, none of the 18 HIPAA identifiers will be placed
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricardo A Gutierrez Ramirez, MD, MSc study director
Universidad Nacional Autonoma de Honduras
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine topical and Saline solution in people with Endometrial Hyperplasia and Endometrial Diseases, run by Ricardo A Gutierrez Ramirez, MD, MSc, FACOG at 1 site in Honduras.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Honduras. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Pain Scale (time frame: Since intervention until 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06784024, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.