Synera™ for Epidural Needle Insertion | NCT00564785

Studies
Synera™ for Epidural Needle Insertion

NCT00564785

Sponsor

IWK Health Centre

Status

Completed

Last Update Posted

Nov 28, 2007Estimated

Enrollment

33Actual

Phase

Phase 4

Conditions

Pain Associated With Epidural Needle Insertion

Interventions

Synera(TM)
Placebo patch

Countries

United States

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

Jan 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2007

Primary Completion Date

Not provided

Completion Date

Mar 2007Actual

First Submitted Date

Nov 27, 2007

First Submission Date that Met QC Criteria

Nov 27, 2007

First Posted Date

Nov 28, 2007Estimated

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

Nov 27, 2007

Last Update Posted Date

Nov 28, 2007Estimated

Name	Class
Duke University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

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

We hypothesized that the analgesic effect of Synera™ analgesic patch would be superior to traditional infiltration with lidocaine for pain of epidural needle insertion in laboring parturients.

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

33Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator		Other: Placebo patch
Synera(TM)	Experimental		Drug: Synera(TM)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Synera(TM)	Drug	Synera(TM) patch applied 20 minutes prior to epidural	Synera(TM)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Subject VRS (0 - 11) with epidural needle insertion		1 hour

Secondary Outcomes

Measure	Description	Time Frame
Anesthesia provider perceived VRS		1 hour
Need for deep infiltration with local anesthesia		1 hour

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

older than 18 years, body mass index less than 45 kg•m-2, requesting a labor epidural

Exclusion Criteria:

hypersensitivity to any study medications

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ronald B George, MD FRCPC	IWK Health Centre	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Duke University Medical Center		Durham	North Carolina	27710	United States