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Study was stopped due to non-availability of the lidocaine placebo patches.
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Infiltration of the skin with lidocaine is standard practice prior to lumbar epidural placement in laboring parturients1. Skin infiltration, although brief, can be very stressful and painful for patients.2 This initial discomfort may cause patient anxiety, thus increasing the pain and decreasing the satisfaction with the procedure. To reduce this discomfort, various topical alternatives have been investigated with varying degrees of success.1-4 Now that a topical mixture of lidocaine that is safe and effective is available, the investigators would like to determine if it can reduce the pain of skin infiltration in particular and epidural placement as a whole.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5% lidocaine patch | Active Comparator | If the patient chooses to participate, the resident will place the patch over the lower lumbar area of the back. |
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| placebo patch | Placebo Comparator | If the patient chooses to participate, the resident will place the patch over the lower lumbar area of the back. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5% lidocaine patch | Drug | Research intervention: After consent has been given, either an active 5% lidocaine patch or an inactive placebo patch will be placed on the lumbar spine of the patient. Both patches appear identical to the physician. The team will then wait for the patient to request an epidural due to labor pain, a minimum of 30 minutes from patch placement and a maximum of 12 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| To determine if the 5% lidocaine patch can decrease the pain from epidural placement. | a minimum of 30 minutes from patch placement and a maximum of 12 hours |
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Inclusion Criteria:
1. Laboring patients between the ages of 18 and 45 with a BMI of less than 45
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard L Applegate, MD | Loma Linda University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University | Loma Linda | California | 92354 | United States |
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| placebo patch | Drug | Research intervention: After consent has been given, either an active 5% lidocaine patch or an inactive placebo patch will be placed on the lumbar spine of the patient. Both patches appear identical to the physician. The team will then wait for the patient to request an epidural due to labor pain, a minimum of 30 minutes from patch placement and a maximum of 12 hours |
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