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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04379102
Other study ID # ntria
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 20, 2018
Est. completion date July 1, 2019

Study information

Verified date May 2020
Source Kanuni Sultan Suleyman Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date July 1, 2019
Est. primary completion date June 20, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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.

Locations

Country Name City State
Turkey Pinar Yalcin Bahat Istanbul I?stanbul

Sponsors (1)

Lead Sponsor Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary The VAS scores of patients after the application of IUDs 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.) 1 month
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