A Comparison of the Post-C/S Analgesic Effects of Neuraxial Duramorph vs Bilateral TAP Block With Liposomal Bupivacaine

Study Overview
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Brief Summary
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The primary objective is to reduce or eliminate the use of all narcotics/opiates for post Cesarean section pain management. The investigators hypothesize that in comparison with epidural or intrathecal Duramorph, a TAP block with liposomal bupivacaine (Exparel) will provide better, longer-acting pain control and will significantly reduce the use of post-operative IV or p.o. opiates. This is a prospective, randomized clinical trial.

Detailed Description
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The investigators will compare the analgesic efficacy and duration of an ultrasound guided bilateral TAP Block (with combined bupivacaine and liposomal bupivacaine) to Duramorph (an opiate). Neuraxial duramorph provides approximately 24 hours of pain relief (analgesia), whereas a bilateral TAP block with liposomal bupivacaine is expected to provide up to 72 hours of analgesia. All participants will have neuraxial anesthesia (either a spinal or epidural) for their non-urgent or elective Cesarean section. The control group (Group 1) will receive either intrathecal or epidural Duramorph (preservative-free morphine sulfate). Post-operatively, participants will have orders to receive, on an as-needed basis, IV/oral acetaminophen and/or IV/oral non-steroidal anti-inflammatory drugs (NSAIDS) for mild-moderate pain, and narcotics for severe pain; specifically- oxycodone or hydromorphone. All patients must receive acetaminophen and NSAIDS (unless contraindicated) before receiving narcotics. This multi-modal pain management regimen is our current standard of care. The experimental group (Group 2) will also receive a spinal or epidural anesthetic. This group will not receive neuraxial Duramorph for post-operative pain. Instead, the patient will receive an ultrasound guided bilateral TAP block with a combination of bupivacaine and liposomal bupivacaine solution immediately after the Cesarean section. Additionally, all participants will receive the same post-operative analgesia orders as group 1.

Official Title
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A Comparison of the Post-cesarean Section Analgesic Effects of Neuraxial Duramorph vs. Bilateral Transverse Abdominal Plane Block With Combined Bupivacaine/Liposomal Bupivacaine (Exparel)

Conditions
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Caesarean Section

Intervention / Treatment
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* Drug: Exparel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females, aged 18-45 years inclusive and ASA physical status 1-3. Undergoing non-urgent Cesarean section with neuraxial anesthesia/analgesia. Subjects must be physically and mentally able to participate in the study and complete all study assessments. Subjects must be able to give fully informed consent to participate in this study after demonstrating a good understanding of the risks and benefits of the proposed components of the TAP infiltration. Exclusion Criteria: History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics Any subject whose anatomy, or surgical procedure, in the opinion of the Investigator, might preclude the potential successful performance of a bilateral TAP infiltration. Any subject who in the opinion of the Investigator, might be harmed or be a poor candidate for participation in the study. Any subject, who in the opinion of the Investigator, is on chronic pain medicine, including large doses of NSAIDs. Subjects who have received any investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during their participation in this study.

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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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
Interventional Model Description: This is a prospective, randomized study evaluating the effectiveness of abdominal analgesia when using 266 mg EXPAREL delivered into the bilateral TAP blocks. TAP blocks are an excellent method for providing adequate analgesia following lower abdominal surgery. Those patients who wish to participate will be asked to sign a study consent form. Patients that decide to participate in this study will be randomized to either group 1 or group 2 (like the flip of a coin). Both groups will receive standard neuraxial anesthesia for their Cesarean Section and post-operative standard of care breakthrough medications for post-operative pain control.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of Care<br>These participant will receive standard neuraxial anesthesia for their Cesarean Section and post-operative standard of care breakthrough medications for post-operative pain control. They standard neuraxial anesthesia with neuraxial Duramorph for post-operative pain. | |
| Active Comparator: Bilateral TAP Block<br>These participants will receive standard neuraxial anesthesia for their Cesarean Section and post-operative standard of care breakthrough medications for post-operative pain control. They will receive standard neuraxial anesthesia without neuraxial Duramorph and a transverse abdominal plane (TAP) blocks immediately after surgery, with a mixture of bupivacaine and Exparel, for post-operative analgesia. | Drug: Exparel<br>* Bilateral TAP Blocks with combination of regular Bupivacaine and EXPAREL<br>* Other names: TAP Block;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Assessed by Visual Analog Scale (VAS) at 48 Hours | To evaluate pain, participant will be shown a card that has a visual analogue (Faces) pains scale combined with numerical (0-10) analogue scale (0 is no pain, 10 is the worst pain imaginable). | 48 hours | 
| Pain Assessed by Visual Analog Scale (VAS) at 72 Hours | To evaluate pain, participant will be shown a card that has a visual analogue (Faces) pains scale combined with numerical (0-10) analogue scale (0 is no pain, 10 is the worst pain imaginable). | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Using Narcotics | Total use of narcotics during the post operative period | 72 hours | 
| Patient Satisfaction With Pain Control Assessed by 11 Point Satisfaction Scale | Patient satisfaction with postsurgical pain management: 0_____1_____2_____3_____4_____5_____6_____7_____8_____9_____10 0=not at all satisfied 10= extremely satisfied | 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cesarean Section, Pregnancy