Lidocaine for Pain Control During Intrauterine Device Insertion

Study Overview
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Brief Summary
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Despite being the most common method of contraception, the use of intrauterine devices (IUDs) is limited by the associated pain during insertion. Many pharmacologic interventions had been studied for their efficacy to reduce IUD insertion pain, of them, lidocaine was found to be superior over NSAIDs or other local anesthetics. This work aims at comparing the safety and efficacy of different lidocaine formulations to optimize selection in reduction of IUD associated pain.

Official Title
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Lidocaine for Pain Control During Intrauterine Device Insertion: A Randomized Clinical Trial

Conditions
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IUD Insertion Complication

Intervention / Treatment
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* Drug: Lidocaine topical


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Multiparous women. Over 18 years of age and eligible for IUD insertion. Application of IUD will be done in postmenstrual period. Exclusion Criteria: Null parity. 2. History of failed intrauterine device insertion (uterine perforation, acute expulsion). 3. Copper allergy. 4. Uterine anomaly. 5. Post-partum endometritis or septic abortion in the past three months. 6. Untreated cervicitis/vaginitis, including bacterial vaginosis. 7. Immunosuppression. 8. History of lidocaine ,prilocaine allergy. 9. Analgesic or anxiolytic use within the last 24 hours before the procedure. 10. Wilson's disease. 11. Suspicion of pregnancy. 12. Untreated abnormal uterine bleeding.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study will include 123 patients who are candidates for IUD contraception. The aim of the study will be explained to all patients and an informed written consent will be taken. After recruitment, patients will be randomized to the 3 study arms using computer generated randomization sheet using MedCalcc version 13 to receive any of: lidocaine spray, cream and injection
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidocaine spray Arm<br>This arm will receive lidocaine spray (Lidocaine topical aerosol ®, 10%, Arab drug co., Egypt) with dose four puffs (50 ml, 10 mg/puff) will be applied to the cervical canal and cervix. | Drug: Lidocaine topical<br>* Local anesthetic for reduction of IUD associated pain<br>|
| Active Comparator: Lidocaine cream Arm<br>This arm will receive topical cream (Pridocaine ®, Global Napi, Egypt) with a dose of 2g lidocaine cream will be applied to the cervix via cotton swab. | Drug: Lidocaine topical<br>* Local anesthetic for reduction of IUD associated pain<br>|
| Active Comparator: Lidocaine injection Arm<br>This arm will receive lidocaine injection (Debocaine®, 2%, Sigma-Tec, Egypt) with a dose of 80-200 mg equivalent to 10 ml lidocaine (20 mg/ml) is injected at four and eight o'clock of the cervico-vaginal junction, and 2 ml to the area to be grasped with the tenaculum for paracervical block. | Drug: Lidocaine topical<br>* Local anesthetic for reduction of IUD associated pain<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scores assessed by 10-point VAS scale | VAS scores will be assessed on at three different points; baseline after application of speculum and analgesic administration, after grasping cervix with tenaculum, then following hysterometry and IUD insertion. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction to IUD insertion | Satisfaction will be assessed post-procedure using patient directed survey | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lidocaine, Dosage forms, Pain scores