Lidocaine for Pain Control During Intrauterine Device Insertion

A

Ain Shams University

Status and phase

Unknown
Phase 4

Conditions

IUD Insertion Complication

Treatments

Drug: Lidocaine topical

Study type

Interventional

Funder types

Other

Identifiers

NCT03362905
Lidocaine in IUD pain

Details and patient eligibility

About

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.

Enrollment

123 estimated patients

Sex

Female

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

123 participants in 3 patient groups

Lidocaine spray Arm
Experimental group
Description:
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.
Treatment:
Drug: Lidocaine topical
Lidocaine cream Arm
Active Comparator group
Description:
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.
Treatment:
Drug: Lidocaine topical
Lidocaine injection Arm
Active Comparator group
Description:
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.
Treatment:
Drug: Lidocaine topical

Trial contacts and locations

0

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Central trial contact

Hadeer Elhagri, M.B.B.Ch

Data sourced from clinicaltrials.gov

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