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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01775605
Recruitment Status : Withdrawn (No participants enrolled)
First Posted : January 25, 2013
Last Update Posted : May 14, 2015
Information provided by (Responsible Party):
Northwell Health

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

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Study Type : Interventional  (Clinical Trial)
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 : November 2013
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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
Drug: Synera
Synera Pain Patch

Primary Outcome Measures :
  1. Rating of pain intensity upon lidocaine infiltration [ Time Frame: 30 minutes (following patch placement , upon lidocaine infiltration) ]

Secondary Outcome Measures :
  1. Subject anxiety [ Time Frame: 1 hour (Upon admission to surgical holding area and after epidural placement) ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01775605

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United States, New York
North Shore Unniversity Hospital
Manhasset, New York, United States, 11030
Sponsors and Collaborators
Northwell Health
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Principal Investigator: Alan Strobel, MD Northwell Health

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Responsible Party: Northwell Health Identifier: NCT01775605    
Other Study ID Numbers: 11-376
First Posted: January 25, 2013    Key Record Dates
Last Update Posted: May 14, 2015
Last Verified: May 2015
Keywords provided by Northwell Health: