Transdermal Lidocaine Administration Prior to Insertion Levonorgestrel-releasing Intrauterine System

Clinical Outcomes of Transdermal Lidocaine Administration Prior to Levonorgestrel Releasing Intrauterine System Insertion in Women Delivered Only by Elective Cesarean Section: a Randomized Double Blinded Clinical Trial

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

Study Overview

• Status: Unknown
• Conditions: IUCD Complication
• Intervention / Treatment: Drug: lidocaine patch; Drug: Sham patch

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Aswan, Egypt, 81528
    • Recruiting
    • Aswan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: lidocaine patch; 5% lidocaine patch applied at 3 hours before the procedure	Drug: lidocaine patch; 5% lidocaine patch applied at 3 hours before the procedure; Other Names: Experimental
Placebo Comparator: Sham patch; Sham patch containing no study medication applied 3 hours before the procedure	Drug: Sham patch; Sham patch containing no study medication applied 3 hours before the procedure; Other Names: Placebo Comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
duration of IUD insertion	duration of IUD insertion measured in minutes	15 minutes

Collaborators and Investigators

• Sponsor: Aswan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Anticipated): August 31, 2021
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: August 15, 2020
• First Submitted That Met QC Criteria: August 15, 2020
• First Posted (Actual): August 19, 2020

Study Record Updates

• Last Update Posted (Actual): September 21, 2020
• Last Update Submitted That Met QC Criteria: September 18, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: aswu/297/3/19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No