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临床试验/NCT05252117
NCT05252117Unknown4 期

Blocking the Uterovaginal Plexus With Artacine for Placement of the Intra Uterine Device

Universidade do Vale do Sapucai1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2021年2月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
发起方
入组人数
240
试验地点
1
主要终点
Pain assessment

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Female patients, aged between 20 and 40 years

排除标准

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

研究组 & 干预措施

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.

干预措施: Articaine Hydrochloride 40 MG/ML (Drug)

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.

干预措施: Mepivacaine (Drug)

结局指标

主要结局

Pain assessment

时间窗: 15 minutes

analog verbal scale numbered from 0 to 3

次要结局

  • sociodemographic data(10 minutes)

研究者

发起方
Universidade do Vale do Sapucai
申办方类型
Other
责任方
Principal Investigator
主要研究者

Thaise de Melo Nery

Principal investigator

Universidade do Vale do Sapucai

研究点 (1)

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