Not provided
Not provided
Not provided
Not provided
Not provided
No participants enrolled
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Synera | Active Comparator | Synera Pain Patch |
|
| No patch control | No Intervention | No intervention group | |
| Control | Sham Comparator | Sham |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Synera | Drug | Synera Pain Patch |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rating of pain intensity upon lidocaine infiltration | 30 minutes (following patch placement , upon lidocaine infiltration) |
| Measure | Description | Time Frame |
|---|---|---|
| Subject anxiety | 1 hour (Upon admission to surgical holding area and after epidural placement) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alan Strobel, MD | Northwell Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Shore Unniversity Hospital | Manhasset | New York | 11030 | United States |
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided