Post-Op Lidocaine Patch

Study Overview
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Brief Summary
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Randomized control trial evaluating use of lidocaine vs placebo patch for post-operative cesarean incision pain.

Detailed Description
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The purpose of this study is to determine if lidocaine patches decrease post-operative pain associated with cesarean births. While the Lidoderm lidocaine patch has been FDA approved for the treatment of skin pain, it has not been studied in women undergoing cesarean birth who experience postoperative pain. Even though this medication has been used in post-operative pain in published studies, the use of this medicine under these circumstances is still considered experimental. A lidocaine patch may provide added benefit for pain control in addition to standard medicines participants would receive after surgery, such as spinal, intravenous, and oral pain medications following cesarean delivery.

Official Title
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Lidocaine Patch for Adjunct Analgesia for Postoperative Cesarean Birth Patients

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Lidoderm 5 % Topical Patch
* Other: Sham Topical Patch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant patients who require a scheduled or non-urgent cesarean birth Patient able to receive neuraxial analgesia Patient able to give verbal and written consent for both cesarean birth and study Exclusion Criteria: Patients requiring emergent cesarean birth Patients allergic to lidocaine or adhesive Patients who have already received an epidural during this admission or requiring general anesthesia for cesarean birth Patients using chronic oral neuromodulators Patients with cardiac disease or using anti-arrhythmic agents Patients with fibromyalgia or chronic pain syndromes such as rheumatoid arthritis, osteoarthritis, or lupus. Daily narcotic or opiate use for greater than the 2 months prior to enrollment in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidoderm 5% Topical Patch<br>5% lidocaine patch applied at 12 hours after cesarean delivery and removed 24 hours after delivery. A second 5% lidocaine patch applied at 36 hours after cesarean delivery and removed at 48 hours after delivery. | Drug: Lidoderm 5 % Topical Patch<br>* Lidocaine patch after cesarean section delivery.<br>* Other names: lidocaine patch;|
| Sham Comparator: Sham Topical Patch<br>Sham patch containing no study medication applied at 12 hours after cesarean delivery and removed 24 hours after delivery. A second sham patch containing no study medication applied at 36 hours after cesarean delivery and removed at 48 hours after delivery. | Other: Sham Topical Patch<br>* Sham patch after cesarean section delivery.<br>* Other names: sham patch;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 12-hour Postoperative Pain Scores | To determine if lidocaine patch is superior to placebo as an adjunctive therapy for acute postoperative pain. Average pain score in women who have undergone cesarean delivery at 12 hours postoperatively. Measured using a Visual Analog Scale (VAS), a scale which measures pain from 0 to 100 with 0=no pain and 100=the worst pain you have ever felt. | Postoperative (12 hours) | 
| 24-hour Postoperative Pain Scores | To determine if lidocaine patch is superior to placebo as an adjunctive therapy for acute postoperative pain. Average pain score in women who have undergone cesarean delivery at 24 hours postoperatively. Measured using a Visual Analog Scale (VAS), a scale which measures pain from 0 to 100 with 0=no pain and 100=the worst pain you have ever felt. | Postoperative (24 hours) | 
| 36-hour Postoperative Pain Scores | To determine if lidocaine patch is superior to placebo as an adjunctive therapy for acute postoperative pain. Average pain score in women who have undergone cesarean delivery at 36 hours postoperatively. Measured using a Visual Analog Scale (VAS), a scale which measures pain from 0 to 100 with 0=no pain and 100=the worst pain you have ever felt. | Postoperative (36 hours) | 
| 48-hour Postoperative Pain Scores | To determine if lidocaine patch is superior to placebo as an adjunctive therapy for acute postoperative pain. Average pain score in women who have undergone cesarean delivery at 48 hours postoperatively. Measured using a Visual Analog Scale (VAS), a scale which measures pain from 0 to 100 with 0=no pain and 100=the worst pain you have ever felt. | Postoperative (48 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5-days Postoperative Narcotic Use | To determine if narcotic use changes when patients use lidocaine patches by counting amount and frequency of narcotic use over admission. Average number of 5 mg oxycodone pills used in women who have undergone cesarean delivery assessed through questionnaire at 5 days postoperatively. | Postoperative (5 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cesarean section, Postoperative pain