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

The Role Of Local Anesthetics Effects During Intrauterine Device Application

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Turkey
  • İ̇stanbul
    • Istanbul, İ̇stanbul, Turkey, 34000
      • Pinar Yalcin Bahat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Women with underlying chronic diseases which could cause chronic pelvic pain such as endometriosis and which makes them prone to infections such as diabetes mellitus were excluded from the study. Furthermore, women by whom a complication had arised during the IUD insertion, such as uterine perforation, were also excluded from the study.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

IUD patients; 80 patients who matched the inclusion criteria and received IUDs

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.; Other Names: without NT/TLA (NT or also referred to as therapy with local anesthetics (TLA) )

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Kanuni Sultan Suleyman Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2018
• Primary Completion (Actual): June 20, 2019
• Study Completion (Actual): July 1, 2019

Study Registration Dates

• First Submitted: May 4, 2020
• First Submitted That Met QC Criteria: May 4, 2020
• First Posted (Actual): May 7, 2020

Study Record Updates

• Last Update Posted (Actual): May 8, 2020
• Last Update Submitted That Met QC Criteria: May 6, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local
• Other Study ID Numbers: ntria

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No