Lidocaine for Pain Control During Intrauterine Device Insertion: A Randomized Clinical Trial
Overview
- Phase
- Phase 4
- Intervention
- Lidocaine topical
- Conditions
- IUD Insertion Complication
- Sponsor
- Ain Shams University
- Enrollment
- 123
- Primary Endpoint
- Pain scores assessed by 10-point VAS scale
- Last Updated
- 8 years ago
Overview
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.
Investigators
Hadeer Abd-El Shafy Fouad
Resident physician
Ain Shams University
Eligibility Criteria
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.
- •History of failed intrauterine device insertion (uterine perforation, acute expulsion).
- •Copper allergy.
- •Uterine anomaly.
- •Post-partum endometritis or septic abortion in the past three months.
- •Untreated cervicitis/vaginitis, including bacterial vaginosis.
- •Immunosuppression.
- •History of lidocaine ,prilocaine allergy.
- •Analgesic or anxiolytic use within the last 24 hours before the procedure.
- •Wilson's disease.
Arms & Interventions
Lidocaine spray Arm
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.
Intervention: Lidocaine topical
Lidocaine cream Arm
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.
Intervention: Lidocaine topical
Lidocaine injection Arm
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.
Intervention: Lidocaine topical
Outcomes
Primary Outcomes
Pain scores assessed by 10-point VAS scale
Time Frame: 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 Outcomes
- Patient satisfaction to IUD insertion(1 year)