Transdermal Lidocaine Administration Prior to Insertion Levonorgestrel-releasing Intrauterine System

Not Applicable

• Conditions: IUCD Complication
• Interventions: Drug: Sham patch; Drug: lidocaine patch

• Registration Number: NCT04517890
• Lead Sponsor: Aswan University Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2020-08-15
• Study First Submitted QC: 2020-08-15
• Study First Posted: 2020-08-19
• Status Verified: 2020-09
• Study Start: 2020-09-01
• Last Update Submitted: 2020-09-18
• Last Update Posted: 2020-09-21
• Primary Completion: 2021-08-31
• Study Completion: 2021-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham patch	Sham patch	Sham patch containing no study medication applied 3 hours before the procedure
lidocaine patch	lidocaine patch	5% lidocaine patch applied at 3 hours before the procedure

Primary Outcome Measures

Name	Time	Method
The difference in pain scores during intrauterine device insertion	10 minutes	The difference in pain scores during intrauterine device insertion using visual analog scale from 0 to 10

Secondary Outcome Measures

Name	Time	Method
duration of IUD insertion	15 minutes	duration of IUD insertion measured in minutes

Trial Locations

Locations (1)

Aswan University Hospital; 🇪🇬 Aswan, Egypt