Transdermal Lidocaine Administration Prior to Insertion Levonorgestrel-releasing Intrauterine System

Study Overview
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Brief Summary
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aims to investigate the effectiveness of Transdermal lidocaine patch for Pain Control During Levonorgestrel Releasing Intrauterine System Insertion in Women Delivered Only by Elective Cesarean Section

Detailed Description
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Long-acting reversible contraception methods are highly effective methods for reduction of the unplanned pregnancy rate worldwide. The intrauterine device is a single procedure that provides reliable, effective and long term contraception for many women. However, the insertion procedure can be associated with a troublesome degree of pain that prevent some women from choosing its use. Different interventions have been described to decrease pain perception during intrauterine device insertion with no agreement on an effective one.

Official Title
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Clinical Outcomes of Transdermal Lidocaine Administration Prior to Levonorgestrel Releasing Intrauterine System Insertion in Women Delivered Only by Elective Cesarean Section: a Randomized Double Blinded Clinical Trial

Conditions
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IUCD Complication

Intervention / Treatment
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* Drug: lidocaine patch
* Drug: Sham patch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non-pregnant women Women that did not receive any analgesics or Dinoprostone in the 24 hours prior to insertion Women who delivered only by cesarean section Exclusion Criteria: Women with any uterine abnormalities as congenital anomalies, endometrial lesions, adenomyosis, fibroids. Those with a Category 3 or 4 conditions for intrauterine device insertion according to the WHO Medical Eligibility Criteria for contraceptive use Allergy to lidocaine Women refuse to participate in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: double blind randomized controlled trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lidocaine patch<br>5% lidocaine patch applied at 3 hours before the procedure | Drug: lidocaine patch<br>* 5% lidocaine patch applied at 3 hours before the procedure<br>* Other names: Experimental;|
| Placebo Comparator: Sham patch<br>Sham patch containing no study medication applied 3 hours before the procedure | Drug: Sham patch<br>* Sham patch containing no study medication applied 3 hours before the procedure<br>* Other names: Placebo Comparator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference in pain scores during intrauterine device insertion | The difference in pain scores during intrauterine device insertion using visual analog scale from 0 to 10 | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of IUD insertion | duration of IUD insertion measured in minutes | 15 minutes |