ContraceptionPhase 4NCT05252117
Uterovaginal Plexus Block With Articaine for Intrauterine Device Placement Patients Who Are Indicated for the Use of Copper IUD as a Contraceptive Method Will be Invited to Participate in This Research.
A Phase 4 study testing Articaine Hydrochloride 40 MG/ML and Mepivacaine in people with Contraception and IUD, run by Universidade do Vale do Sapucai at 1 site in Brazil.
Trial summary
The use of intrauterine device (IUD) in Brazil is still not very significant and one of the reasons is the fear of feeling pain during its insertion procedure. Articaine is an amide-linked local anesthetic, its plasma half-life is shorter than that of most other amide-type anesthetics, which makes it theoretically… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception, IUD, Anesthesia, Local
- What is being tested?
- Articaine Hydrochloride 40 MG/ML and Mepivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Feb 2021to 10 Dec 2022
- Phase
- Phase 4
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female patients, aged between 20 and 40 years
Who cannot join
- Diabetes (type I or II)
- Chronic Kidney
- Urogenital infections
- Psychiatric disesas
- Surgery during the study period
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Universidade do Vale do Sapucaí
Pouso Alegre, Minas Gerais, 37550000
Taylor B Schnaider, Physician
Thaise M Nery, Physician
About this study
Official title: Blocking the Uterovaginal Plexus With Artacine for Placement of the Intra Uterine Device
The use of intrauterine device (IUD) in Brazil is still not very significant and one of the reasons is the fear of feeling pain during its insertion procedure. Articaine is an amide-linked local anesthetic, its plasma half-life is shorter than that of most other amide-type anesthetics, which makes it theoretically favorable in relation to systemic toxicity.
Read the detailed description
Currently, 55% of pregnancies in Brazil are classified as unwanted and approximately only 3% of women use long-term contraception. Intrauterine devices (IUD) are among the most effective long-acting reversible contraceptives, with a failure rate ranging from 0.6 to 0.8% and a duration of 10 years, In Brazil, copper, copper with silver, mirena (levonorgestrel 52mg) and Keelyna (levonorgestrel 13.5mg) IUDs are available. The copper device (T380A) is provided free of charge by the municipal health department. In this sense, they are appropriate methods for most women, including nulliparous women.
Copper IUD, a non-hormonal contraceptive method, causes an inflammatory reaction in the endometrium, with important histological and biochemical changes (increase in cytotoxic cytokines), which interfere with the normal physiology of spermomigration, egg fertilization and blastocyst implantation. Copper ions interfere with vitality and sperm motility, harming them, and also decrease the egg's survival in the genital tract. Copper is responsible for an increase in the production of prostaglandins and inhibition of endometrial enzymes. These changes adversely affect sperm transport so that fertilization rarely occurs. Ovulation is not affected in copper IUD users. Thus, according to available scientific data, copper-containing IUDs act not only in the uterine cavity, but also outside it, interfering with various stages of the reproductive process.
The use of an IUD requires insertion by a duly qualified professional. It is essential that the patient is healthy. Therefore, it is essential: normal gynecological examination; oncotic colpocytology within normal limits; absence of vaginitis, infectious cervicitis, acute or chronic pelvic inflammatory disease, uterine malformations; absence of heart disease, hematological diseases, especially hemorrhagic ones, immune deficiencies; not be pregnant.
The IUD insertion technique is described as follows: Patient in lithotomy position, performing a bimanual vaginal touch and correct assessment of the position of the uterus; vaginal speculum introduction with good exposure of the cervix; antisepsis; clamping of the anterior labrum of the cervix with Pozzi clamp; performing hysterometry - reassessing uterine position and cavity size; place, only at this moment, the IUD inside the applicator shirt; note that the horizontal branches are in the same direction as the lateral diameter of the uterus; insert the applicator with the IUD into the uterus until you feel it has reached the uterine fundus; hold the applicator plunger and pull the shirt, causing the device to extrude into the uterine cavity; carefully remove the applicator; cut the strands, which were left in the vagina, about 2 cm from the external orifice of the cervix. The fear of feeling pain during insertion is one of the reasons for the low acceptance of the method in Brazil. The pain reported by women who undergo IUD insertion without sedation occurs when clamping the cervix, so that the gynecologist can rectify the uterus and when the hysterometer and later the IUD pass through the cervix. Innervation to the uterus and cervix is provided via S2-S4, and visceral pain via afferent fibers from T10-L1. It is believed that the anesthetic instilled in the uterus acts on these nerve endings.
The phenomenon of pain and its concept has often been the subject of several scientific studies. According to the International Association for the Study of Pain, this phenomenon is characterized by an unpleasant sensory and emotional experience, in which there is the perception of a harmful stimulus associated with actual or potential tissue damage.
Anesthesia is the loss of sense or sensation, and local anesthetics are substances that, in contact with a nerve fiber, have the property of interrupting all modalities of nerve inflow. Properly applied local anesthetics are a useful tool to effect a reversible blockade of stimulus conduction (action potential) by nerve fibers (sensory and motor) in the vicinity where they are administered. Local anesthetics are divided into two broad groups: esters and amides. The main structural difference between esters and amides is the bond between the side chain and the saturated ring. When compared to esters, amides are more stable (they can be autoclaved without changing their properties), their hypersensitivity reactions are very rare and, as they undergo hepatic metabolism, they have a longer duration of action.
Articaine, an amide-linked local anesthetic, was approved for use in Brazil in 1999 and has been available in Europe since 1976 and in Canada since 1984. Its plasma half-life is shorter than that of most other amide-type anesthetics. like the other factors, they would be theoretically favorable in relation to systemic toxicity. The potential side effect of the administration of large doses of articaine is methaemoglobinaemia, a reaction perceived after accidental intravenous administration, when performing regional anesthesia. It is a drug biotransformed by plasma and tissue cholinesterases and generates an inactive metabolite, with irrelevant cardiac and neurological toxicity. Because of this, it is an appropriate drug to be used in patients with hepatic and renal dysfunction. Articaine is contraindicated in patients with idiopathic or congenital methaemoglobinaemia, anemia, or cardiac or respiratory failure evidenced by hypoxia.
- Conditions
- Contraception, IUD, Anesthesia, Local
- Being tested
- Articaine Hydrochloride 40 MG/ML, Mepivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Articaine Hydrochloride 40 MG/MLDrug
Analysis of uterovaginal plexus block with articain for intrauterine device placement
MepivacaineDrug
Analysis of uterovaginal plexus block with mepivacaine for intrauterine device placement
| Study group | Role | What they receive |
|---|---|---|
| Articaine 4% | Experimental | With the patient in the lithotomy position, asepsis of the thighs, vulva and vagina will be performed with aqueous chlorhexidine; insertion of vaginal speculum; puncture in the uterine cervix, at the 12h point, injecting 1.8 ml of articaine. After a latency of five minutes, the procedure to insert the IUD will start with clamping the cervix at 12 hours with the Pozzi clamp, followed by rectification of the uterus and hysterometry with the hysterometer. After confirming the hysterometry, the IUD will be inserted with its own applicator and the excess wire will be cut. Receives: Drug: Articaine Hydrochloride 40 MG/ML |
| Mepivacaíne 3% | Experimental | With the patient in the lithotomy position, asepsis of the thighs, vulva and vagina will be performed with aqueous chlorhexidine; insertion of vaginal speculum; puncture in the uterine cervix, at the 12h point, injecting 1.8 ml of Mepivacaine. After a latency of five minutes, the procedure to insert the IUD will start with clamping the cervix at 12 hours with the Pozzi clamp, followed by rectification of the uterus and hysterometry with the hysterometer. After confirming the hysterometry, the IUD will be inserted with its own applicator and the excess wire will be cut. Receives: Drug: Mepivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessment
analog verbal scale numbered from 0 to 3
Measured: 15 minutes
Secondary outcomes (1)
sociodemographic data
data collection questionnaire
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start1 Feb 2021
- Primary completion30 Apr 2022 (estimated)
- Study completion10 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be allocated, according to randomization into one of two groups, after gynecological evaluation at the Gynecology Outpatient Clinic of Hospital das Clínicas Samuel Libânio, in Pouso Alegre. They will be informed about the study and invited to participate and, accepting, signing the Informed Consent Form. Randomization will be followed to define which drug will be used in the patient who will undergo the procedure determined by the study, in a modified lithotomy position, always by the same examiner.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Vale do Sapucai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thaise de Melo Nery, Universidade do Vale do Sapucai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05252117
- Sponsor's protocol ID
- 00001
- Status last verified
- Feb 2022
- First submitted
- 30 Jan 2022
- Last updated
- 23 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD under discussion
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blocking the Uterovaginal Plexus With Artacine for Placement of the Intra Uterine Device
- ClinicalTrials.gov ID
- NCT05252117
- Acronym / sponsor ID
- 00001
- Conditions
- Contraception, IUD, Anesthesia, Local
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Universidade do Vale do SapucaiUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 10 Dec 2022 (estimated)
- First posted
- 23 Feb 2022 (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 use of intrauterine device (IUD) in Brazil is still not very significant and one of the reasons is the fear of feeling pain during its insertion procedure. Articaine is an amide-linked local anesthetic, its plasma half-life is shorter than that of most other amide-type anesthetics, which makes it theoretically favorable in relation to systemic toxicity.
Detailed description
Currently, 55% of pregnancies in Brazil are classified as unwanted and approximately only 3% of women use long-term contraception. Intrauterine devices (IUD) are among the most effective long-acting reversible contraceptives, with a failure rate ranging from 0.6 to 0.8% and a duration of 10 years, In Brazil, copper, copper with silver, mirena (levonorgestrel 52mg) and Keelyna (levonorgestrel 13.5mg) IUDs are available. The copper device (T380A) is provided free of charge by the municipal health department. In this sense, they are appropriate methods for most women, including nulliparous women.
Copper IUD, a non-hormonal contraceptive method, causes an inflammatory reaction in the endometrium, with important histological and biochemical changes (increase in cytotoxic cytokines), which interfere with the normal physiology of spermomigration, egg fertilization and blastocyst implantation. Copper ions interfere with vitality and sperm motility, harming them, and also decrease the egg's survival in the genital tract. Copper is responsible for an increase in the production of prostaglandins and inhibition of endometrial enzymes. These changes adversely affect sperm transport so that fertilization rarely occurs. Ovulation is not affected in copper IUD users. Thus, according to available scientific data, copper-containing IUDs act not only in the uterine cavity, but also outside it, interfering with various stages of the reproductive process.
The use of an IUD requires insertion by a duly qualified professional. It is essential that the patient is healthy. Therefore, it is essential: normal gynecological examination; oncotic colpocytology within normal limits; absence of vaginitis, infectious cervicitis, acute or chronic pelvic inflammatory disease, uterine malformations; absence of heart disease, hematological diseases, especially hemorrhagic ones, immune deficiencies; not be pregnant.
The IUD insertion technique is described as follows: Patient in lithotomy position, performing a bimanual vaginal touch and correct assessment of the position of the uterus; vaginal speculum introduction with good exposure of the cervix; antisepsis; clamping of the anterior labrum of the cervix with Pozzi clamp; performing hysterometry - reassessing uterine position and cavity size; place, only at this moment, the IUD inside the applicator shirt; note that the horizontal branches are in the same direction as the lateral diameter of the uterus; insert the applicator with the IUD into the uterus until you feel it has reached the uterine fundus; hold the applicator plunger and pull the shirt, causing the device to extrude into the uterine cavity; carefully remove the applicator; cut the strands, which were left in the vagina, about 2 cm from the external orifice of the cervix. The fear of feeling pain during insertion is one of the reasons for the low acceptance of the method in Brazil. The pain reported by women who undergo IUD insertion without sedation occurs when clamping the cervix, so that the gynecologist can rectify the uterus and when the hysterometer and later the IUD pass through the cervix. Innervation to the uterus and cervix is provided via S2-S4, and visceral pain via afferent fibers from T10-L1. It is believed that the anesthetic instilled in the uterus acts on these nerve endings.
The phenomenon of pain and its concept has often been the subject of several scientific studies. According to the International Association for the Study of Pain, this phenomenon is characterized by an unpleasant sensory and emotional experience, in which there is the perception of a harmful stimulus associated with actual or potential tissue damage.
Anesthesia is the loss of sense or sensation, and local anesthetics are substances that, in contact with a nerve fiber, have the property of interrupting all modalities of nerve inflow. Properly applied local anesthetics are a useful tool to effect a reversible blockade of stimulus conduction (action potential) by nerve fibers (sensory and motor) in the vicinity where they are administered. Local anesthetics are divided into two broad groups: esters and amides. The main structural difference between esters and amides is the bond between the side chain and the saturated ring. When compared to esters, amides are more stable (they can be autoclaved without changing their properties), their hypersensitivity reactions are very rare and, as they undergo hepatic metabolism, they have a longer duration of action.
Articaine, an amide-linked local anesthetic, was approved for use in Brazil in 1999 and has been available in Europe since 1976 and in Canada since 1984. Its plasma half-life is shorter than that of most other amide-type anesthetics. like the other factors, they would be theoretically favorable in relation to systemic toxicity. The potential side effect of the administration of large doses of articaine is methaemoglobinaemia, a reaction perceived after accidental intravenous administration, when performing regional anesthesia. It is a drug biotransformed by plasma and tissue cholinesterases and generates an inactive metabolite, with irrelevant cardiac and neurological toxicity. Because of this, it is an appropriate drug to be used in patients with hepatic and renal dysfunction. Articaine is contraindicated in patients with idiopathic or congenital methaemoglobinaemia, anemia, or cardiac or respiratory failure evidenced by hypoxia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients will be allocated, according to randomization into one of two groups, after gynecological evaluation at the Gynecology Outpatient Clinic of Hospital das Clínicas Samuel Libânio, in Pouso Alegre. They will be informed about the study and invited to participate and, accepting, signing the Informed Consent Form. Randomization will be followed to define which drug will be used in the patient who will undergo the procedure determined by the study, in a modified lithotomy position, always by the same examiner.
| Arm | Type | Receives |
|---|---|---|
| Articaine 4% | Experimental | Drug: Articaine Hydrochloride 40 MG/MLWith the patient in the lithotomy position, asepsis of the thighs, vulva and vagina will be performed with aqueous chlorhexidine; insertion of vaginal speculum; puncture in the uterine cervix, at the 12h point, injecting 1.8 ml of articaine. After a latency of five minutes, the procedure to insert the IUD will start with clamping the cervix at 12 hours with the Pozzi clamp, followed by rectification of the uterus and hysterometry with the hysterometer. After confirming the hysterometry, the IUD will be inserted with its own applicator and the excess wire will be cut. |
| Mepivacaíne 3% | Experimental | Drug: MepivacaineWith the patient in the lithotomy position, asepsis of the thighs, vulva and vagina will be performed with aqueous chlorhexidine; insertion of vaginal speculum; puncture in the uterine cervix, at the 12h point, injecting 1.8 ml of Mepivacaine. After a latency of five minutes, the procedure to insert the IUD will start with clamping the cervix at 12 hours with the Pozzi clamp, followed by rectification of the uterus and hysterometry with the hysterometer. After confirming the hysterometry, the IUD will be inserted with its own applicator and the excess wire will be cut. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Female patients, aged between 20 and 40 years
Key exclusion criteria (5 listed)
- Diabetes (type I or II)
- Chronic Kidney
- Urogenital infections
- Psychiatric disesas
- Surgery during the study period
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 |
|---|---|---|
| Articaine Hydrochloride 40 MG/MLAnalysis of uterovaginal plexus block with articain for intrauterine device placement | Drug | Articaine 4% |
| MepivacaineAnalysis of uterovaginal plexus block with mepivacaine for intrauterine device placement | Drug | Mepivacaíne 3% |
Primary outcome
Pain assessment
Time frame: 15 minutes
analog verbal scale numbered from 0 to 3
1 secondary outcome
sociodemographic data
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2022.
- Individual participant dataSharing planned: No. IPD under discussion
Related trials for Contraception
Enrolling by invitation
Flo Digital Contraceptive Study
Contraception Use
Recruiting
Estimating the Impact of Sexuality Education and Mobile Health Services on Reproductive Health and Empowerment Among Adolescents in Sierra Leone for the Family Planning Impact Lab
Reproductive Health, Sexual Health
RecruitingPhase 4
Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease
Sickle Cell Disease (SCD), Vaso-Occlusive Pain Episode in Sickle Cell Disease
Not yet recruitingObservational study
FLOW: Influence of the Menstrual Cycle on Alcohol Use in Women
Alcohol Use, Alcohol Consumption
Not yet recruiting
Impact of Gender-Transformative Interventions on Contraceptive Use and Reproductive Autonomy in Somalia
Contraceptive Behavior, Social Norms
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Articaine Hydrochloride 40 MG/ML and Mepivacaine in people with Contraception and IUD, run by Universidade do Vale do Sapucai at 1 site in Brazil.
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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 23 Feb 2022. 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 Brazil. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thaise M Nery, Physician (+55 35 999664418, melo_nery@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain assessment (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Feb 2022.