Transdermal Lidocaine Administration Prior to Insertion L... | NCT04517890

Studies
Transdermal Lidocaine Administration Prior to Insertion Levonorgestrel-releasing Intrauterine System

NCT04517890

Sponsor

Aswan University Hospital

Status

Unknown status

Last Update Posted

Sep 21, 2020Actual

Enrollment

200Estimated

Phase

Not Applicable

Conditions

IUCD Complication

Interventions

lidocaine patch
Sham patch

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2020Actual

Primary Completion Date

Aug 31, 2021Estimated

Completion Date

Sep 1, 2021Estimated

First Submitted Date

Aug 15, 2020

First Submission Date that Met QC Criteria

Aug 15, 2020

First Posted Date

Aug 19, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 18, 2020

Last Update Posted Date

Sep 21, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
lidocaine patch	Experimental	5% lidocaine patch applied at 3 hours before the procedure	Drug: lidocaine patch
Sham patch	Placebo Comparator	Sham patch containing no study medication applied 3 hours before the procedure	Drug: Sham patch

Interventions

Name	Type	Description	Arm Group Labels	Other Names
lidocaine patch	Drug	5% lidocaine patch applied at 3 hours before the procedure	lidocaine patch

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Non-pregnant women who delivered only by cesarean section

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
hany f Sallam, md	Contact	+20102435461	002	hany.farouk@aswu.edu.eg
nahla w Shady, md	Contact	+201022336052	002	hanygyne@yahoo.com

Overall Officials

Name	Affiliation	Role
nahla w Shady, md	Aswan universirty	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aswan University Hospital	Recruiting	Aswān		81528	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided