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.

NCT05252117 | Unknown Phase 4

• 1 other identifier: 00001
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Contraception; IUD; Anesthesia, Local

Outcome Measures

Primary Outcomes (1)

• Pain assessment

  analog verbal scale numbered from 0 to 3

  15 minutes

Secondary Outcomes (1)

• sociodemographic data

  10 minutes

Study Arms (2)

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.

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.

Drug: Mepivacaine

Interventions

Articaine Hydrochloride 40 MG/ML DRUG

Analysis of uterovaginal plexus block with articain for intrauterine device placement

Articaine 4%

Mepivacaine DRUG

Analysis of uterovaginal plexus block with mepivacaine for intrauterine device placement

Mepivacaíne 3%

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: Women aged 20 to 40 years for insertion of the intrauterine device
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- Female patients, aged between 20 and 40 years

You may not qualify if:

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

Sponsors & Collaborators

• Universidade do Vale do Sapucai: lead

Study Sites (1)

Universidade do Vale do Sapucaí

Pouso Alegre, Minas Gerais, 37550000, Brazil

RECRUITING

MeSH Terms

Interventions

Carticaine; Mepivacaine

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperidines

Central Study Contacts

Thaise M Nery, Physician

CONTACT

+55 35 999664418; melo_nery@outlook.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 30, 2022
• First Posted: February 23, 2022
• Study Start: February 1, 2021
• Primary Completion: April 30, 2022
• Study Completion: December 10, 2022
• Last Updated: February 23, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)