Efficacy Study of Topical Application of Lidacaine Spray... | NCT01496105

Studies
Efficacy Study of Topical Application of Lidacaine Spray Prior to IUD Insertion

NCT01496105

Sponsor

Ain Shams University

Status

Unknown status

Last Update Posted

Dec 21, 2011Estimated

Enrollment

200Estimated

Phase

Phase 4

Conditions

Drug Usage

Interventions

Lidocaine
saline

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

Dec 2011

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

Jul 2011

Primary Completion Date

Dec 2011Estimated

Completion Date

Jan 2012Estimated

First Submitted Date

Dec 13, 2011

First Submission Date that Met QC Criteria

Dec 20, 2011

First Posted Date

Dec 21, 2011Estimated

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

Dec 20, 2011

Last Update Posted Date

Dec 21, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mohamed Saied Eldin Elsafty, Lecturer of Obstetrics and Gynecology, Ain Shams UniversityPrincipal Investigator

Lead Sponsor

Ain Shams UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The purpose of this study is to determine whether the topical use of lidocaine spray 10% on the cervix is an effective way to reduce pain during IUCD insertion.

Detailed Description

Not provided

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

Phase 4

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 spray 10%	Active Comparator		Drug: Lidocaine
Saline	Placebo Comparator		Drug: saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lidocaine	Drug		lidocaine spray 10%
saline

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
VAS score of Pain		5 minutes from lidocaine spraying ( after application of tenaculum)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18-45
Speak Arabic or English

Exclusion Criteria:

History of cervical surgery
Known hypersensitivity to topical analgesics
First trimester abortion or miscarriage in the previous six weeks
Second trimester abortion or miscarriage in the previous 12 weeks

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

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
Mohamed S.Eldin Elsafty, Lecturer	Contact	+201003922211		emeira2@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ain shams university hospital	Recruiting	Cairo			Egypt

Intervention Browse Module

MeSH Terms

ID	Term
D008012	Lidocaine
D012965	Sodium Chloride

Ancestor Terms

ID	Term
D000083	Acetanilides
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814

Browse Leaves

Not provided

Browse Branches

Not provided