NCT01775605

Brief Summary

Local infiltration with lidocaine prior to epidural placement for cesarean section, although brief, can be painful. This pain can lead to increased anxiety and distress, adversely affecting patient's overall experience. This study proposes to examine the application of Synera pain patch prior to lidocaine infiltration to reduce this pain and anxiety. The primary objective of this study is to determine the effect of the Synera on maternal experience during epidural placement. The efficacy of Synera pain patch in reducing subject pain during skin infiltration with lidocaine prior to epidural placement in subjects presenting for scheduled cesarean section will be assessed.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 25, 2013

Completed
9 months until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

May 14, 2015

Status Verified

May 1, 2015

Enrollment Period

1 year

First QC Date

December 10, 2012

Last Update Submit

May 13, 2015

Conditions

PainAnxiety

Keywords

Subject

Outcome Measures

Primary Outcomes (1)

  • Rating of pain intensity upon lidocaine infiltration

    30 minutes (following patch placement , upon lidocaine infiltration)

Secondary Outcomes (1)

  • Subject anxiety

    1 hour (Upon admission to surgical holding area and after epidural placement)

Study Arms (3)

Synera

ACTIVE COMPARATOR

Synera Pain Patch

Drug: Synera

No patch control

NO INTERVENTION

No intervention group

Control

SHAM COMPARATOR

Sham

Drug: Synera

Interventions

SyneraDRUG

Synera Pain Patch

ControlSynera

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Over 18 years old;
  • Undergoing pre-scheduled cesarean section;
  • Expected singleton birth;
  • BMI \<=35kg.m-2;

You may not qualify if:

  • Undergoing emergency cesarean section;
  • Complications during pregnancy;
  • History of hypersensitivity to study medication(lidocaine or tetracaine) or para-aminobenzoic acid;
  • Allergies to bird proteins, feathers, or egg products; or any other skin allergies; dermatitis an open wound at the patch site or a history of difficult epidural placement;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Shore Unniversity Hospital

Manhasset, New York, 11030, United States

Location

MeSH Terms

Conditions

PainAnxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Alan Strobel, MD

    Northwell Health

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2012

First Posted

January 25, 2013

Study Start

November 1, 2013

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

May 14, 2015

Record last verified: 2015-05

Locations

US(1)