Transdermal Lidocaine Administration Prior to Insertion Levonorgestrel-releasing Intrauterine System

Aswan University Hospital200 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

200

Conditions

IUCD Complication

Interventions

lidocaine patchDRUG

5% lidocaine patch applied at 3 hours before the procedure

Sham patchDRUG

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (1)

Aswan University Hospital

Aswān, Egypt

RECRUITING

Outcomes

Primary Outcomes

The difference in pain scores during intrauterine device insertion

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

Time frame: 10 minutes

Secondary Outcomes

duration of IUD insertion

duration of IUD insertion measured in minutes

Time frame: 15 minutes

Central Contacts

hany f Sallam, md

CONTACT

+20102435461 hany.farouk@aswu.edu.eg

nahla w Shady, md

CONTACT

+201022336052 hanygyne@yahoo.com

Data from ClinicalTrials.gov

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