Study of Use of Synera for Pain During Local Skin Infiltration With Lidocaine Before Epidural Placement

Sponsor

Northwell Health (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01775605

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain Anxiety	Drug: Synera	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Official Title:

Randomized Study of the Use of Synera for Pain Relief During Local Lidocaine Needle Skin Infiltration for Epidural Placement in Subjects Undergoing Elective Cesarean Section.

Study Start Date :

Nov 1, 2013

Actual Primary Completion Date :

Nov 1, 2014

Actual Study Completion Date :

Nov 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Synera Synera Pain Patch	Drug: Synera Synera Pain Patch
No Intervention: No patch control No intervention group
Sham Comparator: Control Sham	Drug: Synera Synera Pain Patch

Arm

Intervention/Treatment

Active Comparator: Synera

Synera Pain Patch

Drug: Synera

Synera Pain Patch

No Intervention: No patch control

No intervention group

Sham Comparator: Control

Sham

Drug: Synera

Synera Pain Patch

Outcome Measures

Primary Outcome Measures

Rating of pain intensity upon lidocaine infiltration [30 minutes (following patch placement , upon lidocaine infiltration)]

Secondary Outcome Measures

Subject anxiety [1 hour (Upon admission to surgical holding area and after epidural placement)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	North Shore Unniversity Hospital	Manhasset	New York	United States	11030

Sponsors and Collaborators

Northwell Health

Investigators

Principal Investigator: Alan Strobel, MD, Northwell Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Northwell Health

ClinicalTrials.gov Identifier:

NCT01775605

Other Study ID Numbers:

11-376

First Posted:

Jan 25, 2013

Last Update Posted:

May 14, 2015

Last Verified:

May 1, 2015

Keywords provided by Northwell Health

Subject

Study Results

No Results Posted as of May 14, 2015