Lidocaine for Pain Control During Intrauterine Device Insertion

Ain Shams University123 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

123

Conditions

IUD Insertion Complication

Interventions

Lidocaine topicalDRUG

Local anesthetic for reduction of IUD associated pain

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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. 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.

Outcomes

Primary Outcomes

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.

Time frame: 1 year

Secondary Outcomes

Patient satisfaction to IUD insertion

Satisfaction will be assessed post-procedure using patient directed survey

Time frame: 1 year

Central Contacts

Hadeer Elhagri, M.B.B.Ch

CONTACT

01098357256 hadeer.elhagri@med.asu.edu.eg

Data from ClinicalTrials.gov

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