Transdermal Lidocaine Administration Prior to Insertion Levonorgestrel-releasing Intrauterine System

Aswan University Hospital

Status: Unknown

Conditions: IUCD Complication

Treatments: Drug: lidocaine patch; Drug: Sham patch

Study type: Interventional

Funder types: Other

Identifiers

NCT04517890

aswu/297/3/19

Details and patient eligibility

About

aims to investigate the effectiveness of Transdermal lidocaine patch for Pain Control During Levonorgestrel Releasing Intrauterine System Insertion in Women Delivered Only by Elective Cesarean Section

Full description

Long-acting reversible contraception methods are highly effective methods for reduction of the unplanned pregnancy rate worldwide. The intrauterine device is a single procedure that provides reliable, effective and long term contraception for many women. However, the insertion procedure can be associated with a troublesome degree of pain that prevent some women from choosing its use. Different interventions have been described to decrease pain perception during intrauterine device insertion with no agreement on an effective one.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Non-pregnant women
• Women that did not receive any analgesics or Dinoprostone in the 24 hours prior to insertion
• Women who delivered only by cesarean section

Exclusion criteria

• Women with any uterine abnormalities as congenital anomalies, endometrial lesions, adenomyosis, fibroids.
• Those with a Category 3 or 4 conditions for intrauterine device insertion according to the WHO Medical Eligibility Criteria for contraceptive use
• Allergy to lidocaine
• Women refuse to participate in the study

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

lidocaine patch

Experimental group

Description:

5% lidocaine patch applied at 3 hours before the procedure

Treatment:

Drug: lidocaine patch

Sham patch

Placebo Comparator group

Description:

Sham patch containing no study medication applied 3 hours before the procedure

Treatment:

Drug: Sham patch