Transdermal Lidocaine Administration Prior to Insertion Levonorgestrel-releasing Intrauterine System

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2021-09-01

Brief Summary

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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

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Detailed Description

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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.

Conditions

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IUCD Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

double blind randomized controlled trial

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

double blind randomized controlled trial

Study Groups

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lidocaine patch

5% lidocaine patch applied at 3 hours before the procedure

Group Type EXPERIMENTAL

lidocaine patch

Intervention Type DRUG

5% lidocaine patch applied at 3 hours before the procedure

Sham patch

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

Group Type PLACEBO_COMPARATOR

Sham patch

Intervention Type DRUG

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

Interventions

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lidocaine patch

5% lidocaine patch applied at 3 hours before the procedure

Intervention Type DRUG

Sham patch

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

Intervention Type DRUG

Other Intervention Names

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Experimental Placebo Comparator

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No