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.

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.

Study Overview

• Status: Recruiting
• Conditions: Anesthesia, Local; Contraception; IUD
• Intervention / Treatment: Drug: Articaine Hydrochloride 40 MG/ML; Drug: Mepivacaine

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 Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Thaise M Nery, Physician; Phone Number: +55 35 999664418; Email: melo_nery@outlook.com

Study Locations

• Brazil
  • Minas Gerais
    • Pouso Alegre, Minas Gerais, Brazil, 37550000
      • Recruiting
      • Universidade do Vale do Sapucai
      • Contact: Taylor B Schnaider, Physician
      • Principal Investigator: Thaise M Nery, Physician

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

- Female patients, aged between 20 and 40 years

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Analysis of uterovaginal plexus block with articain for intrauterine device placement
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; Analysis of uterovaginal plexus block with mepivacaine for intrauterine device placement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain assessment	analog verbal scale numbered from 0 to 3	15 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sociodemographic data	data collection questionnaire	10 minutes

Collaborators and Investigators

• Sponsor: Universidade do Vale do Sapucai

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Anticipated): April 30, 2022
• Study Completion (Anticipated): December 10, 2022

Study Registration Dates

• First Submitted: January 30, 2022
• First Submitted That Met QC Criteria: February 19, 2022
• First Posted (Actual): February 23, 2022

Study Record Updates

• Last Update Posted (Actual): February 23, 2022
• Last Update Submitted That Met QC Criteria: February 19, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Mepivacaine; Carticaine
• Other Study ID Numbers: 00001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: IPD under discussion

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No