The Role Of Local Anesthetics in the Management of Adverse Effects Associated With Intrauterine Device Application

NCT ID: NCT04379102

Last Updated: 2020-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-20

Study Completion Date

2019-07-01

Brief Summary

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Patients who visited our family planning clinic and opted for IUD application for contraception purposes were also offered NT/TLA treatments simultaneously. 40 patients who matched the inclusion criteria and received IUDs and NT/TLA treatments were included in the study group and 41 patients who only received IUDs were included in the control group. All patients received copper IUDs and none of them were on additional hormonal treatment. Before the insertion of IUD, women in the therapy group received NT treatment with 6ml of 1% procaine injected transvaginal into the cervix at 5 and 7 o'clock localizations. Following IUD insertion, another 6ml of 1% procaine was injected into the Frankenhauser ganglia bilaterally. A final dose of 8ml of 1% procaine was injected into the abdominal trigger points and intracutaneously into the L4-S4 dermatomes as quaddles.

Detailed Description

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Conditions

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IUD Contraception Pain

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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IUD patients

80 patients who matched the inclusion criteria and received IUDs

with NT/TLA (NT or also referred to as therapy with local anesthetics (TLA) )

Intervention Type OTHER

Patients who visited our family planning clinic and opted for IUD application for contraception purposes were also offered NT/TLA treatments simultaneously. 40 patients who matched the inclusion criteria and received IUDs and NT/TLA treatments were included in the study group and 41 patients who only received IUDs were included in the control group. All patients received copper IUDs and none of them were on additional hormonal treatment. Before the insertion of IUD, women in the therapy group received NT treatment with 6ml of 1% procaine injected transvaginal into the cervix at 5 and 7 o'clock localizations.

Interventions

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with NT/TLA (NT or also referred to as therapy with local anesthetics (TLA) )

Patients who visited our family planning clinic and opted for IUD application for contraception purposes were also offered NT/TLA treatments simultaneously. 40 patients who matched the inclusion criteria and received IUDs and NT/TLA treatments were included in the study group and 41 patients who only received IUDs were included in the control group. All patients received copper IUDs and none of them were on additional hormonal treatment. Before the insertion of IUD, women in the therapy group received NT treatment with 6ml of 1% procaine injected transvaginal into the cervix at 5 and 7 o'clock localizations.

Intervention Type OTHER

Other Intervention Names

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without NT/TLA (NT or also referred to as therapy with local anesthetics (TLA) )

Eligibility Criteria

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Inclusion Criteria

* not pregnant women
* healty women age between 18- 45 years old

Exclusion Criteria

* chronic diseases which could cause chronic pelvic pain such as endometriosis
* which makes them prone to infections such as diabetes mellitus
* complication had arised during the IUD insertion, such as uterine perforation
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Kanuni Sultan Suleyman Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Pınar Yalcin bahat

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Pinar Yalcin Bahat

Istanbul, İ̇stanbul, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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ntria

Identifier Type: -

Identifier Source: org_study_id

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