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

Pain Clinical Trial

Official title:

The Role Of Local Anesthetics Effects During Intrauterine Device Application

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04379102
• Other study ID #: ntria
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Contraception
• IUD
• Pain

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