ClinicalTrials.gg
Status unknownNCT05252117Updated Feb 23, 2022

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 interventional study of Articaine Hydrochloride 40 MG/ML and Mepivacaine in Contraception, IUD and Anesthesia, Local, sponsored by Universidade do Vale do Sapucai. Status unknown at 1 site in Brazil. Open to female participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-23.

Sponsored by Universidade do Vale do Sapucai · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2022), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Feb 2021, registered Jan 2022).
Phase
Phase 4
Study type
Interventional
Enrollment
240
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
Female
01

Study 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 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.

02

Conditions studied

  • Contraception
  • IUD
  • Anesthesia, Local
03

In context

Lead sponsor

Universidade do Vale do Sapucai is the lead sponsor of 28 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Female patients, aged between 20 and 40 years

Exclusion criteria

Exclusion Criteria:

  • Diabetes (type I or II)
  • Chronic Kidney
  • Urogenital infections
  • Psychiatric disesas
  • Surgery during the study period
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
240 participants (estimated)

Study arms

  • Experimental
    Articaine 4%

    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.

    Drug: Articaine Hydrochloride 40 MG/ML

  • Experimental
    Mepivacaíne 3%

    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.

    Drug: Mepivacaine

Interventions

  • DrugArticaine Hydrochloride 40 MG/ML

    Drug page: Articaine hydrochloride

    Analysis of uterovaginal plexus block with articain for intrauterine device placement

  • Analysis of uterovaginal plexus block with mepivacaine for intrauterine device placement

06

What researchers measure

Primary outcomes

  1. Pain assessment

    analog verbal scale numbered from 0 to 3

    Time frame: 15 minutes

Secondary outcomes

  1. sociodemographic data

    data collection questionnaire

    Time frame: 10 minutes

07

Study locations

1 of 1 sites recruiting
  • Universidade do Vale do Sapucaí
    Pouso Alegre, Minas Gerais 37550000, Brazil
    Recruiting
    • Taylor B Schnaider, Physician · Contact
    • Thaise M Nery, Physician · Principal investigator
08

References and documents

Individual participant data

Plan to share: No — IPD under discussion

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 23, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05252117
Lead sponsor
Universidade do Vale do Sapucai
Responsible party
Thaise de Melo Nery (Principal investigator, Universidade do Vale do Sapucai) — Principal investigator
First posted
Feb 23, 2022
Start date
Feb 1, 2021
Primary completion
Apr 30, 2022 (estimated)
Completion
Dec 10, 2022 (estimated)
Last update
Feb 23, 2022

Study contacts

Thaise M Nery, Physician
Contact
melo_nery@outlook.com
+55 35 999664418

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Articaine hydrochloride · Mepivacaine

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