Lidocaine Patch for Relief of Pain During Epidural Placement in Laboring Patients

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Controlled Trial of the Lidocaine Patch for Relief of Pain During Epidural Needle Insertion in Laboring Patients

Conditions
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Pregnant, Labor

Intervention / Treatment
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* Drug: 5% lidocaine patch
* Drug: placebo patch


Participation Criteria
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Eligibility Criteria
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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:

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 5% lidocaine patch<br>If the patient chooses to participate, the resident will place the patch over the lower lumbar area of the back. | Drug: 5% lidocaine patch<br>* 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.<br>|
| Placebo Comparator: placebo patch<br>If the patient chooses to participate, the resident will place the patch over the lower lumbar area of the back. | Drug: placebo patch<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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labor, epidural