Transdermal Lidocaine for Pain Control During Diagnostic... | NCT04518202

Studies
Transdermal Lidocaine for Pain Control During Diagnostic Office Hysteroscopy

NCT04518202

Sponsor

Aswan University Hospital

Status

Unknown status

Last Update Posted

Aug 19, 2020Actual

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Infertility, Female

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

Aug 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2020Estimated

Primary Completion Date

Aug 31, 2021Estimated

Completion Date

Sep 30, 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

Aug 15, 2020

Last Update Posted Date

Aug 19, 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

To compare the effectiveness of Transdermal Lidocaine for Pain Control During Diagnostic Office Hysteroscopy

Detailed Description

hysteroscopy is commonly used in the diagnosis and treatment of intrauterine lesions such as polyps, ﬁbroids, septa, and adhesions, and in the presence of abnormal bleeding and during the removal of an intrauterine device or foreign body. Cervical ripening is made possible by the use of medication through different routes.

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 6 hours before the scheduled office hysteroscopy.	Drug: lidocaine patch
Sham patch	Placebo Comparator	Sham patch applied at 6 hours before the scheduled office hysteroscopy.	Drug: Sham patch

Interventions

Name	Type	Description	Arm Group Labels	Other Names
lidocaine patch	Drug	5% lidocaine patch applied at 6 hours before the scheduled office hysteroscopy.	lidocaine patch

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain intensity will be assessed by visual analogue scale	Pain intensity will be assessed by visual analogue scale 30 minutes after the procedure. Visual analogue scale ranging from 0 to 10	10 minutes

Secondary Outcomes

Measure	Description	Time Frame
Operative time	From the introduction of hysteroscope into the vagina till compilation of hysteroscopic examination	15 minutes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with an indication for ofﬁce hysteroscopy

Exclusion Criteria:

patient refuse to participant
contraindication for lidocaine patch

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

patients with an indication for ofﬁce hysteroscopy

Minimum Age

18 Years

Maximum Age

60 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		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

Condition Browse Module

MeSH Terms

ID	Term
D007247	Infertility, Female

Ancestor Terms

ID	Term
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided