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



Status:Not yet recruiting
Conditions:Anxiety, Chronic Pain
Therapuetic Areas:Musculoskeletal, Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:7/11/2015
Start Date:November 2013
Contact:Alan Strobel, MD
Email:astrobel@nshs.edu
Phone:516-562-4887

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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.

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.


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;
We found this trial at
1
site
Manhasset, New York 11030
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mi
from
Manhasset, NY
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