Anxiety, Pain
Conditions
Keywords
Subject
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.
Interventions
DRUGSynera
Synera Pain Patch
Sponsors
Northwell Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rating of pain intensity upon lidocaine infiltration | 30 minutes (following patch placement , upon lidocaine infiltration) |
Secondary
| Measure | Time frame |
|---|---|
| Subject anxiety | 1 hour (Upon admission to surgical holding area and after epidural placement) |
Countries
United States
Outcome results
None listed