The Analgesic Efficacy of Continuous Sub-fascial Bupivacaine Infusion and Lidocaine Patches in Post-cesarean Patients With Opiate Use Disorder: A Comparative Efficacy Analysis

Study Overview
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Brief Summary
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Pregnant women with a history of opioid use disorder, chronic opioid use or those who are on medication assisted treatment will be randomly assigned to receive either a sub-fascial continuous infusion of bupivacaine or lidocaine/menthol patch after Cesarean delivery. Post-operative pain scores and opioid usage in the post-operative period will be recorded.

Detailed Description
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Pregnant women 18 years or older with a history of chronic opioid use, opioid use disorder or women on medication assisted treatment (MAT), will be enrolled in the study and randomly assigned to one of two study groups. The first group will receive a Lidocaine/Menthol patch at the time of her Cesarean delivery, the second will receive placement of the Ambu ACTion infusion pain system at the time of the C-section. This device will be set up to infuse 0.125% of bupivacaine for 48-60hrs postoperatively at a rate of 8cc/hr.

Official Title
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The Analgesic Efficacy of Continuous Sub-fascial Bupivacaine Infusion and Lidocaine Patches in Post-cesarean Patients With Opiate Use Disorder: A Comparative Efficacy Analysis

Conditions
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Opioid-use Disorder, Opioid Use, Opioid Dependence, Opioid Abuse, Medication Assisted Treatment, Infusion Catheter, Wound, Lidopatch, Ambu ACTion, Pregnancy Related, Cesarean Section

Intervention / Treatment
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* Drug: Lidocaine patch
* Device: Ambu ACTion pump, 0.125% bupivacaine at 8cc/hr


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnancy undergoing a Cesarean delivery via a transverse incision at York Hospital labor and delivery Documented history of chronic opioid use or documented OUD, or currently utilizing medically assisted treatment (MAT) Exclusion Criteria: Patients with a history of clinically significant cardiovascular, hepatic, or renal disease Non-English speaking Allergy to bupivacaine, lidocaine, zinc, silver or menthol Unable to consent, due to lack of decisional capacity or need for emergent Cesarean delivery History of glucose-6-phosphate deficiency Use of anti-arrhythmic drugs such as tocainide or mexiletine

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lidoderm patch<br>Participants will receive a topical 3.6% Lidocaine/1.25% Menthol patch at the time of their Cesarean section. Patches will be replaced every 12 hours for a total of 60 hours. | Drug: Lidocaine patch<br>* Lidocaine patch will be applied at time of Cesarean delivery for post-operative pain control.<br>|
| Active Comparator: Infusion pump<br>Participants will undergo placement of Ambu ACTion drug delivery system at the time of Cesarean delivery. 0.125% of bupivacaine will be infused at a rate of 8cc/hr for a total of 48-60hrs post-operatively. | Device: Ambu ACTion pump, 0.125% bupivacaine at 8cc/hr<br>* Infusion pump will be placed at time of Cesarean delivery for post-operative pain control.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scores | Post-operative pain scores using the visual analog scale (a scale that measures pain in 1 unit increments on a scale 0-10 with 0 being no pain at all and 10 being the worst pain imaginable | post-operative until 60 hours postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rescue opioid consumption | Total opioid consumption in MME (morphine milligram equivalent) that patients received post-operatively | post-operative until 60 hours postpartum | 
| Survey of nursing staff | 1-item questionnaire to assess whether nursing felt that patient benefited from therapy. A Likert scale will be used (strongly agree, agree, neutral, disagree, strongly disagree) | between 48-60 hours post-Cesarean delivery | 
| Patient survey | 2-item questionnaire to assess whether patient felt like she benefited from therapy and whether she would elect to use it again in a future C-section. A Likert scale will be used (strongly agree, agree, neutral, disagree, strongly disagree) | between 48-60 hourrs post-Cesarean delivery |