Trial Outcomes & Findings for Obstetric Liposomal Bupivacaine Via Surgical Transversus Abdominis Plane Block for Post Cesarean Pain Control (NCT NCT04897841)

NCT ID: NCT04897841

Last Updated: 2025-08-22

Results Overview

Compared via Student's t-test or Mann-Whitney U test if the distribution is non-normally distributed

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 60 participants
• Primary outcome timeframe: up to 48 hours postpartum
• Results posted on: 2025-08-22

Participant Flow

Participant milestones

Measure	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	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
Overall Study STARTED	29	31
Overall Study COMPLETED	29	31
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Obstetric Liposomal Bupivacaine Via Surgical Transversus Abdominis Plane Block for Post Cesarean Pain Control

Baseline characteristics by cohort

Measure	Control Arm n=29 Participants 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	Intervention: Liposomal Bupivacaine n=31 Participants 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	Total n=60 Participants Total of all reporting groups
Age, Continuous	33.7 years STANDARD_DEVIATION 5.3 • n=5 Participants	33.0 years STANDARD_DEVIATION 3.8 • n=7 Participants	33 years STANDARD_DEVIATION 4.2 • n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants	31 Participants n=7 Participants	60 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=5 Participants	29 Participants n=7 Participants	58 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	25 Participants n=5 Participants	28 Participants n=7 Participants	53 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	29 participants n=5 Participants	31 participants n=7 Participants	60 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 48 hours postpartum

Compared via Student's t-test or Mann-Whitney U test if the distribution is non-normally distributed

Outcome measures

Measure	Control Arm n=29 Participants 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	Intervention: Liposomal Bupivacaine n=31 Participants 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
Total Opioid Usage in Oral Morphine Equivalents	8 morphine milligram equivalents Interval 0.0 to 40.0	2 morphine milligram equivalents Interval 0.0 to 24.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Control Arm n=29 Participants 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	Intervention: Liposomal Bupivacaine n=31 Participants 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
Median Post-operative Pain Scores Measured on NRS	3.75 score on a scale Interval 2.0 to 5.0	3 score on a scale Interval 2.0 to 4.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Control Arm n=29 Participants 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	Intervention: Liposomal Bupivacaine n=31 Participants 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
Maximum Post-operative Pain Scores Measured on NRS First 12 hours postpartum	2.5 score on a scale Interval 2.0 to 5.0	2 score on a scale Interval 1.0 to 3.5
Maximum Post-operative Pain Scores Measured on NRS 12-24 hours postpartum	3.5 score on a scale Interval 2.0 to 4.5	3 score on a scale Interval 2.0 to 4.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Control Arm n=29 Participants 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	Intervention: Liposomal Bupivacaine n=31 Participants 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
Minimum Post-operative Pain Scores Measured on NRS First 12 hours postpartum	2 score on a scale Interval 1.5 to 3.5	2 score on a scale Interval 1.0 to 2.0
Minimum Post-operative Pain Scores Measured on NRS 12-24 hours postpartum	3 score on a scale Interval 2.0 to 4.0	3 score on a scale Interval 2.0 to 3.0

SECONDARY outcome

Timeframe: up to 7 days postpartum

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

Outcome measures

Measure	Control Arm n=29 Participants 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	Intervention: Liposomal Bupivacaine n=31 Participants 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
Incidence of Opioid Side Effects Respiratory events	0 Participants	0 Participants
Incidence of Opioid Side Effects Pruritis	0 Participants	1 Participants
Incidence of Opioid Side Effects Constipation	0 Participants	0 Participants
Incidence of Opioid Side Effects Nausea and/or vomiting	2 Participants	2 Participants
Incidence of Opioid Side Effects Mental clouding	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Control Arm n=29 Participants 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	Intervention: Liposomal Bupivacaine n=31 Participants 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
Percentage of Participants With Adverse Events	10 % of participants with adverse events	6 % of participants with adverse events

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Control Arm n=29 Participants 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	Intervention: Liposomal Bupivacaine n=31 Participants 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
Time to First Rescue Analgesic Medication	21.8 minutes Interval 5.1 to 29.2	18.2 minutes Interval 3.2 to 29.5

SECONDARY outcome

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

Outcome measures

Measure	Control Arm n=29 Participants 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	Intervention: Liposomal Bupivacaine n=31 Participants 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
Total Dose of Opioids in Oral Morphine Equivalents 12 hours postpartum	0 morphine milligram equivalents Interval 0.0 to 0.0	0 morphine milligram equivalents Interval 0.0 to 6.0
Total Dose of Opioids in Oral Morphine Equivalents 24 hours postpartum	0 morphine milligram equivalents Interval 0.0 to 8.0	0 morphine milligram equivalents Interval 0.0 to 8.0
Total Dose of Opioids in Oral Morphine Equivalents 72 hours postpartum	24 morphine milligram equivalents Interval 0.0 to 40.0	6 morphine milligram equivalents Interval 0.0 to 32.0
Total Dose of Opioids in Oral Morphine Equivalents entire hospital stay	24 morphine milligram equivalents Interval 0.0 to 40.0	6 morphine milligram equivalents Interval 0.0 to 46.0

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 7 days postpartum

Outcome measures

Measure	Control Arm n=29 Participants 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	Intervention: Liposomal Bupivacaine n=31 Participants 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
Length of Postpartum Hospital Stay	2.97 Days Interval 2.76 to 3.81	2.82 Days Interval 2.09 to 3.13

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 7 days postpartum

Number of participants requiring supplemental oxygen use

Outcome measures

Measure	Control Arm n=29 Participants 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	Intervention: Liposomal Bupivacaine n=31 Participants 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
Incidence of Supplemental Oxygen Use During Hospitalization	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 7 days postpartum

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

Outcome measures

Measure	Control Arm n=29 Participants 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	Intervention: Liposomal Bupivacaine n=31 Participants 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
Number of Participants Breastfeeding at Hospital Discharge Breastfeeding with supplementation	3 Participants	2 Participants
Number of Participants Breastfeeding at Hospital Discharge Exclusive breastfeeding	26 Participants	29 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 7 days postpartum

Outcome measures

Measure	Control Arm n=29 Participants 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	Intervention: Liposomal Bupivacaine n=31 Participants 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
Amount of Opioid Prescribed at Discharge	10 number of opioid tablets Interval 0.0 to 15.0	0 number of opioid tablets Interval 0.0 to 10.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 weeks postpartum

Outcome measures

Measure	Control Arm n=29 Participants 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	Intervention: Liposomal Bupivacaine n=31 Participants 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
Percentage of Participants With Opioid Refills Requested	8.33 percentage of participants with refill	3.6 percentage of participants with refill

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 weeks postpartum

Outcome measures

Measure	Control Arm n=29 Participants 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	Intervention: Liposomal Bupivacaine n=31 Participants 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
Number of Opioid Pills Used	0 number of pills used Interval 0.0 to 3.0	0 number of pills used Interval 0.0 to 1.5

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 weeks postpartum

Participants self-reported feeling down or depressed

Outcome measures

Measure	Control Arm n=29 Participants 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	Intervention: Liposomal Bupivacaine n=31 Participants 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
Postnatal Depression Screen	10 Participants	12 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 weeks postpartum

2 weeks postpartum, participants will be asked to report whether they would recommend the treatment they received

Outcome measures

Measure	Control Arm n=29 Participants 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	Intervention: Liposomal Bupivacaine n=31 Participants 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
Percentage of Participants Who Would Recommend Treatment	81.0 percent who would recommend treatment	78.6 percent who would recommend treatment

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 weeks postpartum

6 weeks postpartum, participants will be asked whether they would recommend the treatment they received.

Outcome measures

Measure	Control Arm n=29 Participants 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	Intervention: Liposomal Bupivacaine n=31 Participants 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
6 Week Postpartum Satisfaction Survey Response Percentage	70.8 percent who would recommend treatment	78.6 percent who would recommend treatment

OTHER_PRE_SPECIFIED outcome

Timeframe: at birth

Outcome measures

Measure	Control Arm n=29 Participants 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	Intervention: Liposomal Bupivacaine n=31 Participants 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
Fetal Weight	3312 grams Standard Deviation 540	3395 grams Standard Deviation 448

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Measure	Control Arm n=29 Participants 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	Intervention: Liposomal Bupivacaine n=31 Participants 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
Five-minute Apgar Scores	8.79 score on a scale Standard Deviation 0.49	8.74 score on a scale Standard Deviation .68

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 7 days postpartum

NICU admission is a potential confounding variable for maternal opioid use.

Outcome measures

Measure	Control Arm n=29 Participants 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	Intervention: Liposomal Bupivacaine n=31 Participants 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
Number of Participants With at Least One Newborn Admitted to the Neonatal Intensive Care Unit (NICU)	5 Participants	5 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 6 weeks postpartum

Outcome measures

Measure	Control Arm n=29 Participants 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	Intervention: Liposomal Bupivacaine n=31 Participants 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
Number of Participants Readmitted to the Hospital	0 Participants	2 Participants

Adverse Events

Control Arm

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Intervention: Liposomal Bupivacaine

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	Control Arm n=29 participants at risk 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	Intervention: Liposomal Bupivacaine n=31 participants at risk 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
Reproductive system and breast disorders Post-partum hemorrhage	0.00% 0/29 • 6 weeks post-partum	3.2% 1/31 • Number of events 1 • 6 weeks post-partum
Eye disorders Nystagmus	3.4% 1/29 • Number of events 1 • 6 weeks post-partum	0.00% 0/31 • 6 weeks post-partum

Other adverse events

Measure	Control Arm n=29 participants at risk 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	Intervention: Liposomal Bupivacaine n=31 participants at risk 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
Skin and subcutaneous tissue disorders Local burning or blistering	6.9% 2/29 • Number of events 2 • 6 weeks post-partum	9.7% 3/31 • Number of events 3 • 6 weeks post-partum
General disorders Dizziness	3.4% 1/29 • Number of events 1 • 6 weeks post-partum	6.5% 2/31 • Number of events 2 • 6 weeks post-partum
Skin and subcutaneous tissue disorders Edema, erythema, pruritis, or irritation at site of injection	0.00% 0/29 • 6 weeks post-partum	3.2% 1/31 • Number of events 1 • 6 weeks post-partum
Cardiac disorders Arrythmias	3.4% 1/29 • Number of events 1 • 6 weeks post-partum	3.2% 1/31 • Number of events 1 • 6 weeks post-partum
Nervous system disorders Confusion or tremors	3.4% 1/29 • Number of events 1 • 6 weeks post-partum	0.00% 0/31 • 6 weeks post-partum
Investigations Any potential or definitive local anesthetic systemic toxicity or symptoms (LAST)	6.9% 2/29 • Number of events 2 • 6 weeks post-partum	3.2% 1/31 • Number of events 1 • 6 weeks post-partum
Skin and subcutaneous tissue disorders Pruritis	0.00% 0/29 • 6 weeks post-partum	3.2% 1/31 • Number of events 1 • 6 weeks post-partum
Gastrointestinal disorders Nausea and vomiting	6.9% 2/29 • Number of events 2 • 6 weeks post-partum	6.5% 2/31 • Number of events 2 • 6 weeks post-partum
General disorders Mental clouding	3.4% 1/29 • Number of events 1 • 6 weeks post-partum	3.2% 1/31 • Number of events 1 • 6 weeks post-partum

Additional Information

Sharon Blohowiak

University of Wisconsin - Madison

Phone: 608-417-6957

Email: sblohowiak@wisc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place