Cesarean Section Complications, Opioid Use, Pain
Conditions
Keywords
cesarean
Brief summary
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.
Detailed description
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.
Interventions
DRUGLiposomal bupivacaine
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.
DRUGBupivacaine Hydrochloride
30 mL bupivacaine hydrochloride 0.25 percent, local post-surgical anesthetic
OTHERsaline
post-surgical saline
Sponsors
Meriter Foundation
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Maternal age greater than or equal to 18 * Singleton or multifetal pregnancy * Able to receive neuraxial analgesia * Planned/ scheduled Cesarean delivery OR non-urgent Cesarean delivery at UnityPoint-Health Meriter with adequate time to consider and consent to the study * Able to provide consent in English
Exclusion criteria
* Known hypersensitivity to bupivacaine (defined as a history of a reaction or allergy to bupivacaine (injectable, intravenous, or transdermal) reported by patient or documented in the medical record * Contraindication to regional analgesia * Positive urine drug screen at admission to the hospital, if ordered for clinical purposes. * Current opioid use or opioid use disorder per patient report or documented in the medical record * Chronic opioid use or opioid use disorder, either patient reported or documented in the medical record, defined as opioid use on most days for greater than 3 months * Planned cesarean hysterectomy (excluded due to anticipated blood loss and alternative pain control measures, possible prolonged intubation) * Planned vertical midline incision (excluded due to possible different postpartum pain) * Presence of renal dysfunction precluding the use of NSAIDs (NSAIDs are part of the usual postpartum pain regimen/ hospital protocol) per discretion of the treating physician or PI * Ischemic heart disease, congestive heart failure, or cardiomyopathy of pregnancy precluding the use of NSAIDs (NSAIDs are part of the usual postpartum pain regimen/ hospital protocol) per discretion of the treating physician or PI * Significant liver dysfunction precluding the use of acetaminophen (acetaminophen is part of the usual postpartum pain regimen/ hospital protocol) per discretion of the treating physician or PI * Coagulopathy * Planned discharge from the hospital less than 48 hours postpartum * Unable to receive post-operative scheduled acetaminophen for any reason, such as allergy to acetaminophen or elevated liver function tests precluding acetaminophen use * Unable to receive post-operative scheduled NSAIDs for any reason, such as allergy to ketorolac or ibuprofen, or renal dysfunction precluding NSAID use * Seizure disorder: Specifically, poorly controlled seizure disorder defined as having had a seizure within the last three years despite antiepileptic use or poorly managed seizure disorder due to medication non-compliance. * Cardiac disease or arrhythmia: Defined as ischemic heart disease, peripartum cardiomyopathy, heart failure (with reduced or preserved ejection fraction, compensated or decompensated). Patients with a remote history of non-cyanotic pediatric cardiac surgery (like a VSD closure or PDA ligation as a child) do not need to be excluded. History of adult cardiac surgery without ongoing problems or treatments other than chronic anticoagulation (mitral valve repair for MVP or aortic valve replacement for bicuspid aortic valve for example) would not need to be excluded. History of repaired congenital cyanotic heart disease should be considered for exclusion, ultimately up to the anesthesiologist that day. A patient with a history of arrhythmias not requiring medication or ablation would NOT need to be excluded and could be included in the study. History of ablation or active anti-arrhythmic medication should be considered for exclusion. * Hypoxia: Defined as requiring supplemental oxygen during the day. * Acidosis. This will be uncommon in our population, but if someone has active diabetic ketoacidosis will exclude.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Opioid Usage in Oral Morphine Equivalents | up to 48 hours postpartum | Compared via Student's t-test or Mann-Whitney U test if the distribution is non-normally distributed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Post-operative Pain Scores Measured on NRS | Collected per standard of care every 4-6 hours up to 24 hours postpartum | Numeric rating scale (NRS) which rates pain on a 0-10 scale where 10 is increased pain. |
| Minimum Post-operative Pain Scores Measured on NRS | Collected per standard of care every 4-6 hours up to 24 hours postpartum | Numeric rating scale (NRS) which rates pain on a 0-10 scale where 10 is increased pain. |
| Incidence of Opioid Side Effects | up to 7 days postpartum | Number of patients reporting opioid-related side effects, such as pruritis, constipation, nausea, and mental clouding. |
| Median Post-operative Pain Scores Measured on NRS | Collected per standard of care every 4-6 hours up to 24 hours postpartum | Numeric rating scale (NRS) which rates pain on a 0-10 scale where 10 is increased pain. |
| Time to First Rescue Analgesic Medication | up to 7 days postpartum | 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. |
| Total Dose of Opioids in Oral Morphine Equivalents | at 12, 24, 72 hours postpartum and entire hospital stay | — |
| Percentage of Participants With Adverse Events | up to 7 days postpartum | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Would Recommend Treatment | 2 weeks postpartum | 2 weeks postpartum, participants will be asked to report whether they would recommend the treatment they received |
| 6 Week Postpartum Satisfaction Survey Response Percentage | 6 weeks postpartum | 6 weeks postpartum, participants will be asked whether they would recommend the treatment they received. |
| Fetal Weight | at birth | — |
| Number of Participants With at Least One Newborn Admitted to the Neonatal Intensive Care Unit (NICU) | up to 7 days postpartum | NICU admission is a potential confounding variable for maternal opioid use. |
| Number of Participants Readmitted to the Hospital | up to 6 weeks postpartum | — |
| Five-minute Apgar Scores | 5 minutes after birth | The Apgar Score is a measure of fetal health status immediately after birth. It comprises five components: 1) color, 2) heart rate, 3) reflexes, 4) muscle tone, and 5) respiration, each of which is given a score of 0, 1, or 2 for a total possible score of 0-10, where higher scores indicate better health. |
| Length of Postpartum Hospital Stay | up to 7 days postpartum | — |
| Incidence of Supplemental Oxygen Use During Hospitalization | up to 7 days postpartum | Number of participants requiring supplemental oxygen use |
| Number of Participants Breastfeeding at Hospital Discharge | up to 7 days postpartum | Breastfeeding rates, both exclusive and breastfeeding with supplementation at the time of discharge |
| Amount of Opioid Prescribed at Discharge | up to 7 days postpartum | — |
| Percentage of Participants With Opioid Refills Requested | 6 weeks postpartum | — |
| Number of Opioid Pills Used | 6 weeks postpartum | — |
| Postnatal Depression Screen | 6 weeks postpartum | Participants self-reported feeling down or depressed |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Arm The control arm will receive 30 mL of bupivacaine HCl plus 50 mL of saline injected into the lateral transversus abdominis plane via surgical approach (abdominal approach).
Bupivacaine Hydrochloride: 30 mL bupivacaine hydrochloride 0.25 percent, local post-surgical anesthetic
saline: post-surgical saline | 29 |
| Intervention: Liposomal Bupivacaine The intervention arm will receive 30 mL of bupivacaine HCl plus 30 mL of saline plus 20 mL of liposomal bupivacaine injected into the lateral transversus abdominis plane via surgical approach (abdominal approach).
Liposomal bupivacaine: 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.
Bupivacaine Hydrochloride: 30 mL bupivacaine hydrochloride 0.25 percent, local post-surgical anesthetic
saline: post-surgical saline | 31 |
| Total | 60 |
Baseline characteristics
| Characteristic | Control Arm | Total | Intervention: Liposomal Bupivacaine |
|---|---|---|---|
| Age, Continuous | 33.7 years STANDARD_DEVIATION 5.3 | 33 years STANDARD_DEVIATION 4.2 | 33.0 years STANDARD_DEVIATION 3.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants | 58 Participants | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) White | 25 Participants | 53 Participants | 28 Participants |
| Region of Enrollment United States | 29 participants | 60 participants | 31 participants |
| Sex: Female, Male Female | 29 Participants | 60 Participants | 31 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 31 |
| other Total, other adverse events | 8 / 29 | 7 / 31 |
| serious Total, serious adverse events | 1 / 29 | 1 / 31 |
Outcome results
Primary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control Arm | Total Opioid Usage in Oral Morphine Equivalents | 8 morphine milligram equivalents |
| Intervention: Liposomal Bupivacaine | Total Opioid Usage in Oral Morphine Equivalents | 2 morphine milligram equivalents |
Secondary
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control Arm | Incidence of Opioid Side Effects | Pruritis | 0 Participants |
| Control Arm | Incidence of Opioid Side Effects | Nausea and/or vomiting | 2 Participants |
| Control Arm | Incidence of Opioid Side Effects | Constipation | 0 Participants |
| Control Arm | Incidence of Opioid Side Effects | Mental clouding | 1 Participants |
| Control Arm | Incidence of Opioid Side Effects | Respiratory events | 0 Participants |
| Intervention: Liposomal Bupivacaine | Incidence of Opioid Side Effects | Mental clouding | 1 Participants |
| Intervention: Liposomal Bupivacaine | Incidence of Opioid Side Effects | Respiratory events | 0 Participants |
| Intervention: Liposomal Bupivacaine | Incidence of Opioid Side Effects | Pruritis | 1 Participants |
| Intervention: Liposomal Bupivacaine | Incidence of Opioid Side Effects | Constipation | 0 Participants |
| Intervention: Liposomal Bupivacaine | Incidence of Opioid Side Effects | Nausea and/or vomiting | 2 Participants |
Secondary
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
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control Arm | Maximum Post-operative Pain Scores Measured on NRS | First 12 hours postpartum | 2.5 score on a scale |
| Control Arm | Maximum Post-operative Pain Scores Measured on NRS | 12-24 hours postpartum | 3.5 score on a scale |
| Intervention: Liposomal Bupivacaine | Maximum Post-operative Pain Scores Measured on NRS | First 12 hours postpartum | 2 score on a scale |
| Intervention: Liposomal Bupivacaine | Maximum Post-operative Pain Scores Measured on NRS | 12-24 hours postpartum | 3 score on a scale |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control Arm | Median Post-operative Pain Scores Measured on NRS | 3.75 score on a scale |
| Intervention: Liposomal Bupivacaine | Median Post-operative Pain Scores Measured on NRS | 3 score on a scale |
Secondary
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
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control Arm | Minimum Post-operative Pain Scores Measured on NRS | First 12 hours postpartum | 2 score on a scale |
| Control Arm | Minimum Post-operative Pain Scores Measured on NRS | 12-24 hours postpartum | 3 score on a scale |
| Intervention: Liposomal Bupivacaine | Minimum Post-operative Pain Scores Measured on NRS | First 12 hours postpartum | 2 score on a scale |
| Intervention: Liposomal Bupivacaine | Minimum Post-operative Pain Scores Measured on NRS | 12-24 hours postpartum | 3 score on a scale |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Arm | Percentage of Participants With Adverse Events | 10 % of participants with adverse events |
| Intervention: Liposomal Bupivacaine | Percentage of Participants With Adverse Events | 6 % of participants with adverse events |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control Arm | Time to First Rescue Analgesic Medication | 21.8 minutes |
| Intervention: Liposomal Bupivacaine | Time to First Rescue Analgesic Medication | 18.2 minutes |
Secondary
Total Dose of Opioids in Oral Morphine Equivalents
Time frame: at 12, 24, 72 hours postpartum and entire hospital stay
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control Arm | Total Dose of Opioids in Oral Morphine Equivalents | 12 hours postpartum | 0 morphine milligram equivalents |
| Control Arm | Total Dose of Opioids in Oral Morphine Equivalents | 24 hours postpartum | 0 morphine milligram equivalents |
| Control Arm | Total Dose of Opioids in Oral Morphine Equivalents | 72 hours postpartum | 24 morphine milligram equivalents |
| Control Arm | Total Dose of Opioids in Oral Morphine Equivalents | entire hospital stay | 24 morphine milligram equivalents |
| Intervention: Liposomal Bupivacaine | Total Dose of Opioids in Oral Morphine Equivalents | entire hospital stay | 6 morphine milligram equivalents |
| Intervention: Liposomal Bupivacaine | Total Dose of Opioids in Oral Morphine Equivalents | 12 hours postpartum | 0 morphine milligram equivalents |
| Intervention: Liposomal Bupivacaine | Total Dose of Opioids in Oral Morphine Equivalents | 72 hours postpartum | 6 morphine milligram equivalents |
| Intervention: Liposomal Bupivacaine | Total Dose of Opioids in Oral Morphine Equivalents | 24 hours postpartum | 0 morphine milligram equivalents |
Other Pre-specified
6 Week Postpartum Satisfaction Survey Response Percentage
6 weeks postpartum, participants will be asked whether they would recommend the treatment they received.
Time frame: 6 weeks postpartum
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Arm | 6 Week Postpartum Satisfaction Survey Response Percentage | 70.8 percent who would recommend treatment |
| Intervention: Liposomal Bupivacaine | 6 Week Postpartum Satisfaction Survey Response Percentage | 78.6 percent who would recommend treatment |
Other Pre-specified
Amount of Opioid Prescribed at Discharge
Time frame: up to 7 days postpartum
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control Arm | Amount of Opioid Prescribed at Discharge | 10 number of opioid tablets |
| Intervention: Liposomal Bupivacaine | Amount of Opioid Prescribed at Discharge | 0 number of opioid tablets |
Other Pre-specified
Fetal Weight
Time frame: at birth
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Arm | Fetal Weight | 3312 grams | Standard Deviation 540 |
| Intervention: Liposomal Bupivacaine | Fetal Weight | 3395 grams | Standard Deviation 448 |
Other Pre-specified
Five-minute Apgar Scores
The Apgar Score is a measure of fetal health status immediately after birth. It comprises five components: 1) color, 2) heart rate, 3) reflexes, 4) muscle tone, and 5) respiration, each of which is given a score of 0, 1, or 2 for a total possible score of 0-10, where higher scores indicate better health.
Time frame: 5 minutes after birth
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Arm | Five-minute Apgar Scores | 8.79 score on a scale | Standard Deviation 0.49 |
| Intervention: Liposomal Bupivacaine | Five-minute Apgar Scores | 8.74 score on a scale | Standard Deviation 0.68 |
Other Pre-specified
Incidence of Supplemental Oxygen Use During Hospitalization
Number of participants requiring supplemental oxygen use
Time frame: up to 7 days postpartum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Arm | Incidence of Supplemental Oxygen Use During Hospitalization | 0 Participants |
| Intervention: Liposomal Bupivacaine | Incidence of Supplemental Oxygen Use During Hospitalization | 0 Participants |
Other Pre-specified
Length of Postpartum Hospital Stay
Time frame: up to 7 days postpartum
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control Arm | Length of Postpartum Hospital Stay | 2.97 Days |
| Intervention: Liposomal Bupivacaine | Length of Postpartum Hospital Stay | 2.82 Days |
Other Pre-specified
Number of Opioid Pills Used
Time frame: 6 weeks postpartum
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control Arm | Number of Opioid Pills Used | 0 number of pills used |
| Intervention: Liposomal Bupivacaine | Number of Opioid Pills Used | 0 number of pills used |
Other Pre-specified
Number of Participants Breastfeeding at Hospital Discharge
Breastfeeding rates, both exclusive and breastfeeding with supplementation at the time of discharge
Time frame: up to 7 days postpartum
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control Arm | Number of Participants Breastfeeding at Hospital Discharge | Exclusive breastfeeding | 26 Participants |
| Control Arm | Number of Participants Breastfeeding at Hospital Discharge | Breastfeeding with supplementation | 3 Participants |
| Intervention: Liposomal Bupivacaine | Number of Participants Breastfeeding at Hospital Discharge | Exclusive breastfeeding | 29 Participants |
| Intervention: Liposomal Bupivacaine | Number of Participants Breastfeeding at Hospital Discharge | Breastfeeding with supplementation | 2 Participants |
Other Pre-specified
Number of Participants Readmitted to the Hospital
Time frame: up to 6 weeks postpartum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Arm | Number of Participants Readmitted to the Hospital | 0 Participants |
| Intervention: Liposomal Bupivacaine | Number of Participants Readmitted to the Hospital | 2 Participants |
Other Pre-specified
Number of Participants With at Least One Newborn Admitted to the Neonatal Intensive Care Unit (NICU)
NICU admission is a potential confounding variable for maternal opioid use.
Time frame: up to 7 days postpartum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Arm | Number of Participants With at Least One Newborn Admitted to the Neonatal Intensive Care Unit (NICU) | 5 Participants |
| Intervention: Liposomal Bupivacaine | Number of Participants With at Least One Newborn Admitted to the Neonatal Intensive Care Unit (NICU) | 5 Participants |
Other Pre-specified
Percentage of Participants Who Would Recommend Treatment
2 weeks postpartum, participants will be asked to report whether they would recommend the treatment they received
Time frame: 2 weeks postpartum
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Arm | Percentage of Participants Who Would Recommend Treatment | 81.0 percent who would recommend treatment |
| Intervention: Liposomal Bupivacaine | Percentage of Participants Who Would Recommend Treatment | 78.6 percent who would recommend treatment |
Other Pre-specified
Percentage of Participants With Opioid Refills Requested
Time frame: 6 weeks postpartum
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Arm | Percentage of Participants With Opioid Refills Requested | 8.33 percentage of participants with refill |
| Intervention: Liposomal Bupivacaine | Percentage of Participants With Opioid Refills Requested | 3.6 percentage of participants with refill |
Other Pre-specified
Postnatal Depression Screen
Participants self-reported feeling down or depressed
Time frame: 6 weeks postpartum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Arm | Postnatal Depression Screen | 10 Participants |
| Intervention: Liposomal Bupivacaine | Postnatal Depression Screen | 12 Participants |