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

Completed

• Conditions: IUD; Contraception; Pain
• Interventions: Other: with NT/TLA (NT or also referred to as therapy with local anesthetics (TLA) )

• Registration Number: NCT04379102
• Lead Sponsor: Kanuni Sultan Suleyman Training and Research Hospital

Brief Summary

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

Not available

Study Timeline

• Study Start: 2018-01-20
• Primary Completion: 2019-06-20
• Study Completion: 2019-07-01
• Status Verified: 2020-05
• Study First Submitted: 2020-05-04
• Study First Submitted QC: 2020-05-04
• Last Update Submitted: 2020-05-06
• Study First Posted: 2020-05-07
• Last Update Posted: 2020-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
IUD patients	with NT/TLA (NT or also referred to as therapy with local anesthetics (TLA) )	80 patients who matched the inclusion criteria and received IUDs

Primary Outcome Measures

Name	Time	Method
The VAS scores of patients after the application of IUDs	1 month	The VAS scores of patients in both groups reported one month after the application of IUDs (Patients mark their pain intensity from 1 to 10 in vas scoring. In scoring, 1 point is the lowest score and shows that the patient has low pain, 10 is the highest score and shows severe pain.)

Trial Locations

Locations (1)

Pinar Yalcin Bahat; 🇹🇷 Istanbul, İ̇stanbul, Turkey