Obstetric Liposomal Bupivacaine Via Surgical Transversus... | NCT04897841

ID	Type	Description
A532860	Other Identifier	UW Madison
SMPH/OBSTET & GYNECOL	Other Identifier	UW Madison
Protocol Version 6/13/2022	Other Identifier	Meriter IRB
2021-0410	Other Identifier	UW-Madison IRB

Name	Class
Meriter Foundation	OTHER

Label	Type	Description	Intervention Names
control arm	Placebo Comparator	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).	Drug: Bupivacaine Hydrochloride Other: saline
Intervention: liposomal bupivacaine	Experimental	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).	Drug: Liposomal bupivacaine Drug: Bupivacaine Hydrochloride Other: saline

Name	Type	Description	Arm Group Labels	Other Names
Liposomal bupivacaine	Drug	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.

Measure	Description	Time Frame
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	up to 48 hours postpartum

Measure	Description	Time Frame
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.	Collected per standard of care every 4-6 hours up to 24 hours postpartum
Maximum Post-operative Pain Scores Measured on NRS

Measure	Description	Time Frame
Length of Postpartum Hospital Stay		up to 7 days postpartum
Incidence of Supplemental Oxygen Use During Hospitalization	Number of participants requiring supplemental oxygen use	up to 7 days postpartum

Name	Affiliation	Role
Kathleen M Antony, MD, MSCI	University of Wisconsin, Madison	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Unity-Point Health Meriter		Madison	Wisconsin	53715	United States

PubMed Identifier	Type	Citation	Retractions
38154599	Derived	Antony KM, McDonald RC, Gaston L, Hetzel S, Li Z. Surgical transversus abdominis plane block with liposomal bupivacaine at cesarean: a pilot randomized trial. Am J Obstet Gynecol MFM. 2024 Feb;6(2):101273. doi: 10.1016/j.ajogmf.2023.101273. Epub 2023 Dec 26.

ID	Title	Description
FG000	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
FG001

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Sep 11, 2022

ID	Title	Description
BG000	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
BG001	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
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00029 BG00131 BG00260

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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

Posted

Median

Inter-Quartile Range

morphine milligram equivalents

up to 48 hours postpartum

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants	OG00029 OG00131

Title

Denominators

Categories

Title	Measurements
	OG0008(0 to 40) OG0012(0 to 24)

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.

Posted

Median

Inter-Quartile Range

score on a scale

Collected per standard of care every 4-6 hours up to 24 hours postpartum

ID	Title	Description
OG000	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
OG001	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

Units	Counts

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.

Posted

Median

Inter-Quartile Range

score on a scale

Collected per standard of care every 4-6 hours up to 24 hours postpartum

ID	Title	Description
OG000	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
OG001	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

Units	Counts

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.

Posted

Median

Inter-Quartile Range

score on a scale

Collected per standard of care every 4-6 hours up to 24 hours postpartum

ID	Title	Description
OG000	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
OG001	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

Units	Counts

Secondary

Incidence of Opioid Side Effects

Number of patients reporting opioid-related side effects, such as pruritis, constipation, nausea, and mental clouding.

Posted

Count of Participants

Participants

up to 7 days postpartum

ID	Title	Description
OG000	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
OG001	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

Units	Counts

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

Posted

Number

% of participants with adverse events

up to 7 days postpartum

ID	Title	Description
OG000	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
OG001	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

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.

Posted

Median

Inter-Quartile Range

minutes

up to 7 days postpartum

ID	Title	Description
OG000	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
OG001	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

Units	Counts

Secondary

Total Dose of Opioids in Oral Morphine Equivalents

Posted

Median

Inter-Quartile Range

morphine milligram equivalents

at 12, 24, 72 hours postpartum and entire hospital stay

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants

Other Pre-specified

Length of Postpartum Hospital Stay

Posted

Median

Inter-Quartile Range

Days

up to 7 days postpartum

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants

Other Pre-specified

Incidence of Supplemental Oxygen Use During Hospitalization

Number of participants requiring supplemental oxygen use

Posted

Count of Participants

Participants

up to 7 days postpartum

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants

Other Pre-specified

Number of Participants Breastfeeding at Hospital Discharge

Breastfeeding rates, both exclusive and breastfeeding with supplementation at the time of discharge

Posted

Count of Participants

Participants

up to 7 days postpartum

ID	Title	Description
OG000	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
OG001	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

Units	Counts

Other Pre-specified

Amount of Opioid Prescribed at Discharge

Posted

Median

Inter-Quartile Range

number of opioid tablets

up to 7 days postpartum

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants

Other Pre-specified

Percentage of Participants With Opioid Refills Requested

Posted

Number

percentage of participants with refill

6 weeks postpartum

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants

Other Pre-specified

Number of Opioid Pills Used

Posted

Median

Inter-Quartile Range

number of pills used

6 weeks postpartum

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants

Other Pre-specified

Postnatal Depression Screen

Participants self-reported feeling down or depressed

Posted

Count of Participants

Participants

6 weeks postpartum

ID	Title	Description
OG000	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
OG001	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

Units	Counts
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

Posted

Number

percent who would recommend treatment

2 weeks postpartum

ID	Title	Description
OG000	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
OG001	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

Units	Counts

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.

Posted

Number

percent who would recommend treatment

6 weeks postpartum

ID	Title	Description
OG000	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
OG001	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

Units	Counts

Other Pre-specified

Fetal Weight

Posted

Mean

Standard Deviation

grams

at birth

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants

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.

Posted

Mean

Standard Deviation

score on a scale

5 minutes after birth

ID	Title	Description
OG000	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
OG001	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

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.

Posted

Count of Participants

Participants

up to 7 days postpartum

ID	Title	Description
OG000	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
OG001	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

Units	Counts

Other Pre-specified

Number of Participants Readmitted to the Hospital

Posted

Count of Participants

Participants

up to 6 weeks postpartum

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Post-partum hemorrhage	Reproductive system and breast disorders		Systematic Assessment		EG0000 events0 affected29 at risk EG0011 events1 affected31 at risk
Nystagmus	Eye disorders		Systematic Assessment		EG0001 events1 affected29 at risk EG0010 events0 affected31 at risk

Term	Organ System	Assessment Type	Statistical Information
Local burning or blistering	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0002 events2 affected29 at risk EG0013 events3 affected31 at risk
Dizziness	General disorders	Systematic Assessment	EG0001 events1 affected29 at risk EG0012 events2 affected31 at risk
Edema, erythema, pruritis, or irritation at site of injection	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected31 at risk
Arrythmias	Cardiac disorders	Systematic Assessment	EG0001 events1 affected29 at risk EG0011 events1 affected31 at risk
Confusion or tremors	Nervous system disorders	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected31 at risk
Any potential or definitive local anesthetic systemic toxicity or symptoms (LAST)	Investigations	Systematic Assessment	EG0002 events2 affected29 at risk EG0011 events1 affected31 at risk
Pruritis	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected31 at risk
Nausea and vomiting	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected29 at risk EG0012 events2 affected31 at risk
Mental clouding	General disorders	Systematic Assessment	EG0001 events1 affected29 at risk EG0011 events1 affected31 at risk

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D002045	Bupivacaine
D012965	Sodium Chloride

ID	Term
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814	Aniline Compounds
D000588	Amines
D002712	Chlorides
D006851	Hydrochloric Acid
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017670	Sodium Compounds

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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	0	29	1	29	8	29
EG001	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	0	31	1	31	7	31