This study seeks to identify whether the addition of liposomal bupivacaine to regular bupivacaine and saline administered via surgical transversus abdominis plane (TAP) block will reduce the cumulative opioid dose in the first 48 hours after cesarean. 60 women scheduled for cesarean at Unity-Point Health Meriter Hospital in Madison, Wisconsin will be enrolled and can be expect to be on study for up to 6 weeks post-partum.
The purpose of this study is to determine whether liposomal bupivacaine administered via surgical TAP block at the time of Cesarean delivery will reduce the total dose of opioids received. The hypothesis is that liposomal bupivacaine will reduce the total dose of opioids received in the immediate 48 hours post-delivery. Secondary outcomes will include participant self-reported pain scores, participant-reported incidence of side effects, and development of objective complications such as dysrhythmias. Other outcomes collected will include length of stay, time to first rescue analgesic medication, total dose of opioids at 12, 24, 36, 72 hours and during the hospital stay, use of supplemental oxygen during hospitalization, breastfeeding rates, both exclusive and in combination with formula use, amount of opioid prescribed at discharge and whether refills were requested or administered, rates of chronic pain at six weeks postpartum, and six week Edinburgh Depression Screen scores. Neonatal outcomes such as fetal weight, five-minute Apgar scores and development of adverse outcomes such as neonatal intensive care unit (NICU) admission will also be collected because NICU admission can impact maternal opioid use. Primary Objective: * To determine whether liposomal bupivacaine administered via surgical TAP block at the time of cesarean delivery will reduce the total dose of opioids received in the first 48 hours after surgery. * Hypothesis: The hypothesis is that liposomal bupivacaine administered via surgical TAP block at the time of cesarean delivery will reduce the total dose of opioids received in the first 48 hours after surgery. * Developmental Sub Aim: If liposomal bupivacaine administered via surgical TAP block does reduce the total dose of opioids received, to determine the degree of the reduction in order to allow for an adequately powered randomized-controlled trial. Secondary Objective: * To determine whether liposomal bupivacaine administered via surgical TAP block at the time of cesarean delivery will reduce patient-reported pain scores and opioid-related side effects, including respiratory compromise. * Hypothesis: The hypothesis is that liposomal bupivacaine administered via surgical TAP block at the time of cesarean will reduce patient-reported pain scores and opioid related side effects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
20 mL prior to closing fascia, the active drug (bupivacaine) is encapsulated in a liposomal platform and released slowly over the course of days with an approximate 72 hour duration.
30 mL bupivacaine hydrochloride 0.25 percent, local post-surgical anesthetic
post-surgical saline
Unity-Point Health Meriter
Madison, Wisconsin, United States
Total Opioid Usage in Oral Morphine Equivalents
Compared via Student's t-test or Mann-Whitney U test if the distribution is non-normally distributed
Time frame: up to 48 hours postpartum
Median Post-operative Pain Scores Measured on NRS
Numeric rating scale (NRS) which rates pain on a 0-10 scale where 10 is increased pain.
Time frame: Collected per standard of care every 4-6 hours up to 24 hours postpartum
Maximum Post-operative Pain Scores Measured on NRS
Numeric rating scale (NRS) which rates pain on a 0-10 scale where 10 is increased pain.
Time frame: Collected per standard of care every 4-6 hours up to 24 hours postpartum
Minimum Post-operative Pain Scores Measured on NRS
Numeric rating scale (NRS) which rates pain on a 0-10 scale where 10 is increased pain.
Time frame: Collected per standard of care every 4-6 hours up to 24 hours postpartum
Incidence of Opioid Side Effects
Number of patients reporting opioid-related side effects, such as pruritis, constipation, nausea, and mental clouding.
Time frame: up to 7 days postpartum
Percentage of Participants With Adverse Events
Percentage of complications of bupivacaine, such as local burning, nausea, dizziness, drowsiness, serious skin reactions such as blistering, confusion, blurred vision, ringing in the ears, arrhythmias, methemoglobinemia, and allergies and hypersensitivities
Time frame: up to 7 days postpartum
Time to First Rescue Analgesic Medication
Time to first rescue analgesic medication, measured in minutes from arrival in the post-anesthesia care unit (PACU) until the first as needed opioid dose is administered.
Time frame: up to 7 days postpartum
Total Dose of Opioids in Oral Morphine Equivalents
Time frame: at 12, 24, 72 hours postpartum and entire hospital stay
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