Lidocaine for Pain Control During Intrauterine Device Insertion

Phase 4

• Conditions: IUD Insertion Complication
• Interventions: Drug: Lidocaine topical

• Registration Number: NCT03362905
• Lead Sponsor: Ain Shams University

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2017-11
• Study First Submitted: 2017-11-30
• Study First Submitted QC: 2017-11-30
• Last Update Submitted: 2017-11-30
• Study Start: 2017-12-03
• Study First Posted: 2017-12-05
• Last Update Posted: 2017-12-05
• Primary Completion: 2018-12-05
• Study Completion: 2019-01-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 123

Inclusion Criteria

1. Multiparous women.
2. Over 18 years of age and eligible for IUD insertion.
3. Application of IUD will be done in postmenstrual period.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lidocaine spray Arm	Lidocaine topical	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.
Lidocaine cream Arm	Lidocaine topical	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.
Lidocaine injection Arm	Lidocaine topical	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.

Primary Outcome Measures

Name	Time	Method
Pain scores assessed by 10-point VAS scale	1 year	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.

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction to IUD insertion	1 year	Satisfaction will be assessed post-procedure using patient directed survey