Trial Outcomes & Findings for Efficacy and Safety of EXPAREL Versus Standard of Care (SoC) in Subjects Undergoing Elective Cesarean Section (NCT NCT03853694)

NCT ID: NCT03853694

Last Updated: 2022-07-18

Results Overview

To Compare total opioid consumption through 72 hours following EXPAREL infiltration into the Transversus abdominus plane (TAP) with SOC in subjects undergoing an elective C-section

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 167 participants
• Primary outcome timeframe: Through 72 hours post-surgery
• Results posted on: 2022-07-18

Participant Flow

Participant milestones

Measure	Group 1 (Standard of Care Group) 150 mcg Duramorph® + postoperative multi-modal pain regimen. No EXPAREL TAP infiltration 150 mcg Duramorph + multi-modal pain regimen: Intrathecal injection of 150 mcg Duramorph + multi-modal pain regimen.	Group 2 (Duramorph + EXPAREL TAP) 50 mcg Duramorph + EXPAREL TAP infiltration + postoperative multi-modal pain regimen. 50 mcg Duramorph+ EXPAREL + multi-modal pain regimen: Intrathecal injection of 50 mcg Duramorph + EXPAREL administered via TAP infiltration + multi-modal pain regimen.	Group 3 (EXPAREL TAP) EXPAREL TAP infiltration + postoperative multi-modal pain regimen. No Duramorph. Exparel TAP + multi-modal pain regimen: EXPAREL administered via TAP infiltration + multi-modal pain regimen.
Overall Study STARTED	56	56	55
Overall Study COMPLETED	53	47	51
Overall Study NOT COMPLETED	3	9	4

Reasons for withdrawal

Measure	Group 1 (Standard of Care Group) 150 mcg Duramorph® + postoperative multi-modal pain regimen. No EXPAREL TAP infiltration 150 mcg Duramorph + multi-modal pain regimen: Intrathecal injection of 150 mcg Duramorph + multi-modal pain regimen.	Group 2 (Duramorph + EXPAREL TAP) 50 mcg Duramorph + EXPAREL TAP infiltration + postoperative multi-modal pain regimen. 50 mcg Duramorph+ EXPAREL + multi-modal pain regimen: Intrathecal injection of 50 mcg Duramorph + EXPAREL administered via TAP infiltration + multi-modal pain regimen.	Group 3 (EXPAREL TAP) EXPAREL TAP infiltration + postoperative multi-modal pain regimen. No Duramorph. Exparel TAP + multi-modal pain regimen: EXPAREL administered via TAP infiltration + multi-modal pain regimen.
Overall Study Protocol Violation	3	5	3
Overall Study Delivered early	0	1	0
Overall Study not suitable to proceed	0	1	0
Overall Study difficult surgery	0	0	1
Overall Study Lost to Follow-up	0	1	0
Overall Study Withdrawal by Subject	0	1	0

Baseline Characteristics

Efficacy and Safety of EXPAREL Versus Standard of Care (SoC) in Subjects Undergoing Elective Cesarean Section

Baseline characteristics by cohort

Measure	Group 1 (Standard of Care Group) n=53 Participants 150 mcg Duramorph® + postoperative multi-modal pain regimen. No EXPAREL TAP infiltration 150 mcg Duramorph + multi-modal pain regimen: Intrathecal injection of 150 mcg Duramorph + multi-modal pain regimen.	Group 2 (Duramorph + EXPAREL TAP) n=48 Participants 50 mcg Duramorph + EXPAREL TAP infiltration + postoperative multi-modal pain regimen. 50 mcg Duramorph+ EXPAREL + multi-modal pain regimen: Intrathecal injection of 50 mcg Duramorph + EXPAREL administered via TAP infiltration + multi-modal pain regimen.	Group 3 (EXPAREL TAP) n=52 Participants EXPAREL TAP infiltration + postoperative multi-modal pain regimen. No Duramorph. Exparel TAP + multi-modal pain regimen: EXPAREL administered via TAP infiltration + multi-modal pain regimen.	Total n=153 Participants Total of all reporting groups
Age, Continuous	33.2 years STANDARD_DEVIATION 4.67 • n=93 Participants	34.1 years STANDARD_DEVIATION 4.93 • n=4 Participants	32.7 years STANDARD_DEVIATION 5.03 • n=27 Participants	33.3 years STANDARD_DEVIATION 4.88 • n=483 Participants
Sex: Female, Male Female	53 Participants n=93 Participants	48 Participants n=4 Participants	52 Participants n=27 Participants	153 Participants n=483 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=93 Participants	5 Participants n=4 Participants	7 Participants n=27 Participants	18 Participants n=483 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	46 Participants n=93 Participants	43 Participants n=4 Participants	45 Participants n=27 Participants	134 Participants n=483 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Asian	3 Participants n=93 Participants	5 Participants n=4 Participants	8 Participants n=27 Participants	16 Participants n=483 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Black or African American	5 Participants n=93 Participants	3 Participants n=4 Participants	7 Participants n=27 Participants	15 Participants n=483 Participants
Race (NIH/OMB) White	41 Participants n=93 Participants	36 Participants n=4 Participants	34 Participants n=27 Participants	111 Participants n=483 Participants
Race (NIH/OMB) More than one race	1 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	2 Participants n=483 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=93 Participants	3 Participants n=4 Participants	3 Participants n=27 Participants	9 Participants n=483 Participants
Region of Enrollment United States	53 participants n=93 Participants	48 participants n=4 Participants	52 participants n=27 Participants	153 participants n=483 Participants
American Society of Anesthesiologists (ASA) Physical Status Classification ASA I	2 Participants n=93 Participants	0 Participants n=4 Participants	3 Participants n=27 Participants	5 Participants n=483 Participants
American Society of Anesthesiologists (ASA) Physical Status Classification ASA II	47 Participants n=93 Participants	45 Participants n=4 Participants	39 Participants n=27 Participants	131 Participants n=483 Participants
American Society of Anesthesiologists (ASA) Physical Status Classification ASA III	4 Participants n=93 Participants	3 Participants n=4 Participants	10 Participants n=27 Participants	17 Participants n=483 Participants
Body Mass Index (pre-pregnancy)	31.69 kg/m^2 STANDARD_DEVIATION 5.091 • n=93 Participants	31.08 kg/m^2 STANDARD_DEVIATION 5.181 • n=4 Participants	32.23 kg/m^2 STANDARD_DEVIATION 6.179 • n=27 Participants	31.68 kg/m^2 STANDARD_DEVIATION 5.490 • n=483 Participants

PRIMARY outcome

Timeframe: Through 72 hours post-surgery

To Compare total opioid consumption through 72 hours following EXPAREL infiltration into the Transversus abdominus plane (TAP) with SOC in subjects undergoing an elective C-section

Outcome measures

Measure	Group 1 (Standard of Care Group) n=53 Participants 150 mcg Duramorph® + postoperative multi-modal pain regimen. No EXPAREL TAP infiltration 150 mcg Duramorph + multi-modal pain regimen: Intrathecal injection of 150 mcg Duramorph + multi-modal pain regimen.	Group 2 (Duramorph + EXPAREL TAP) n=47 Participants 50 mcg Duramorph + EXPAREL TAP infiltration + postoperative multi-modal pain regimen. 50 mcg Duramorph+ EXPAREL + multi-modal pain regimen: Intrathecal injection of 50 mcg Duramorph + EXPAREL administered via TAP infiltration + multi-modal pain regimen.	Group 3 (EXPAREL TAP) n=51 Participants EXPAREL TAP infiltration + postoperative multi-modal pain regimen. No Duramorph. Exparel TAP + multi-modal pain regimen: EXPAREL administered via TAP infiltration + multi-modal pain regimen.
Total Postsurgical Opioid Consumption Through 72 Hours	69.3 OMED mg Standard Error 1.15	36.1 OMED mg Standard Error 1.16	22.1 OMED mg Standard Error 1.16

SECONDARY outcome

Timeframe: through 72 hours or hospital discharge, whichever came first

Population: LS Means probability from the logistic regression with treatment, site, age, and height as explanatory variables.

Percentage of opioid-free subjects. LS Means probability from the logistic regression with treatment, site, age, and height as explanatory variables.

Outcome measures

Measure	Group 1 (Standard of Care Group) n=53 Participants 150 mcg Duramorph® + postoperative multi-modal pain regimen. No EXPAREL TAP infiltration 150 mcg Duramorph + multi-modal pain regimen: Intrathecal injection of 150 mcg Duramorph + multi-modal pain regimen.	Group 2 (Duramorph + EXPAREL TAP) n=47 Participants 50 mcg Duramorph + EXPAREL TAP infiltration + postoperative multi-modal pain regimen. 50 mcg Duramorph+ EXPAREL + multi-modal pain regimen: Intrathecal injection of 50 mcg Duramorph + EXPAREL administered via TAP infiltration + multi-modal pain regimen.	Group 3 (EXPAREL TAP) n=51 Participants EXPAREL TAP infiltration + postoperative multi-modal pain regimen. No Duramorph. Exparel TAP + multi-modal pain regimen: EXPAREL administered via TAP infiltration + multi-modal pain regimen.
Percentage of Opioid-free Subjects	22.4 percentage of participants, opioid free	28.8 percentage of participants, opioid free	30 percentage of participants, opioid free

SECONDARY outcome

Timeframe: through 72 hours after surgery

Severity of itching (Numeric Rating Scale score from 0(being none)-10(being the worst))

Outcome measures

Measure	Group 1 (Standard of Care Group) n=50 Participants 150 mcg Duramorph® + postoperative multi-modal pain regimen. No EXPAREL TAP infiltration 150 mcg Duramorph + multi-modal pain regimen: Intrathecal injection of 150 mcg Duramorph + multi-modal pain regimen.	Group 2 (Duramorph + EXPAREL TAP) n=44 Participants 50 mcg Duramorph + EXPAREL TAP infiltration + postoperative multi-modal pain regimen. 50 mcg Duramorph+ EXPAREL + multi-modal pain regimen: Intrathecal injection of 50 mcg Duramorph + EXPAREL administered via TAP infiltration + multi-modal pain regimen.	Group 3 (EXPAREL TAP) n=48 Participants EXPAREL TAP infiltration + postoperative multi-modal pain regimen. No Duramorph. Exparel TAP + multi-modal pain regimen: EXPAREL administered via TAP infiltration + multi-modal pain regimen.
Severity of Itching (Numeric Rating Scale Score)	1.48 score on a scale Standard Error 0.161	0.94 score on a scale Standard Error 0.176	0.61 score on a scale Standard Error 0.167

SECONDARY outcome

Timeframe: through 72 hours after surgery

The Opioid-Related Symptom Distress Scale (ORSDS) is a 4-point scale that evaluates 3 symptom distress dimensions (frequency, severity, bothersomeness) for 10 symptoms. The symptom-specific ORSDS is the average of the 3 symptom distress dimensions. The composite ORSDS is the average of 10 symptom-specific scores. Each question will receive a score from 0-4 the composite score for each subject is the average of all scores. A higher score indicates a worse outcome.

Outcome measures

Measure	Group 1 (Standard of Care Group) n=53 Participants 150 mcg Duramorph® + postoperative multi-modal pain regimen. No EXPAREL TAP infiltration 150 mcg Duramorph + multi-modal pain regimen: Intrathecal injection of 150 mcg Duramorph + multi-modal pain regimen.	Group 2 (Duramorph + EXPAREL TAP) n=47 Participants 50 mcg Duramorph + EXPAREL TAP infiltration + postoperative multi-modal pain regimen. 50 mcg Duramorph+ EXPAREL + multi-modal pain regimen: Intrathecal injection of 50 mcg Duramorph + EXPAREL administered via TAP infiltration + multi-modal pain regimen.	Group 3 (EXPAREL TAP) n=51 Participants EXPAREL TAP infiltration + postoperative multi-modal pain regimen. No Duramorph. Exparel TAP + multi-modal pain regimen: EXPAREL administered via TAP infiltration + multi-modal pain regimen.
Opioid Related Symptom Distress Scale Score (ORSDS)	0.33 score on a scale Standard Error 0.055	0.23 score on a scale Standard Error 0.053	0.35 score on a scale Standard Error 0.051

Adverse Events

Group 1 (Standard of Care Group)

Serious events: 2 serious events

Other events: 43 other events

Deaths: 0 deaths

Group 2 (Duramorph + EXPAREL TAP)

Serious events: 2 serious events

Other events: 41 other events

Deaths: 0 deaths

Group 3 (EXPAREL TAP)

Serious events: 2 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Measure	Group 1 (Standard of Care Group) n=53 participants at risk 150 mcg Duramorph® + postoperative multi-modal pain regimen. No EXPAREL TAP infiltration 150 mcg Duramorph + multi-modal pain regimen: Intrathecal injection of 150 mcg Duramorph + multi-modal pain regimen.	Group 2 (Duramorph + EXPAREL TAP) n=48 participants at risk 50 mcg Duramorph + EXPAREL TAP infiltration + postoperative multi-modal pain regimen. 50 mcg Duramorph+ EXPAREL + multi-modal pain regimen: Intrathecal injection of 50 mcg Duramorph + EXPAREL administered via TAP infiltration + multi-modal pain regimen.	Group 3 (EXPAREL TAP) n=52 participants at risk EXPAREL TAP infiltration + postoperative multi-modal pain regimen. No Duramorph. Exparel TAP + multi-modal pain regimen: EXPAREL administered via TAP infiltration + multi-modal pain regimen.
Injury, poisoning and procedural complications Postpartum hemorrhage	0.00% 0/53 • Adverse events and serious adverse events (SAEs) were recorded from the time the ICF was signed through Day 14.	0.00% 0/48 • Adverse events and serious adverse events (SAEs) were recorded from the time the ICF was signed through Day 14.	1.9% 1/52 • Number of events 1 • Adverse events and serious adverse events (SAEs) were recorded from the time the ICF was signed through Day 14.
Injury, poisoning and procedural complications Abdominal wall hematoma	0.00% 0/53 • Adverse events and serious adverse events (SAEs) were recorded from the time the ICF was signed through Day 14.	0.00% 0/48 • Adverse events and serious adverse events (SAEs) were recorded from the time the ICF was signed through Day 14.	1.9% 1/52 • Number of events 1 • Adverse events and serious adverse events (SAEs) were recorded from the time the ICF was signed through Day 14.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/53 • Adverse events and serious adverse events (SAEs) were recorded from the time the ICF was signed through Day 14.	2.1% 1/48 • Number of events 1 • Adverse events and serious adverse events (SAEs) were recorded from the time the ICF was signed through Day 14.	0.00% 0/52 • Adverse events and serious adverse events (SAEs) were recorded from the time the ICF was signed through Day 14.
Gastrointestinal disorders Constipation	0.00% 0/53 • Adverse events and serious adverse events (SAEs) were recorded from the time the ICF was signed through Day 14.	2.1% 1/48 • Number of events 1 • Adverse events and serious adverse events (SAEs) were recorded from the time the ICF was signed through Day 14.	0.00% 0/52 • Adverse events and serious adverse events (SAEs) were recorded from the time the ICF was signed through Day 14.
Injury, poisoning and procedural complications Incision Site Pain	1.9% 1/53 • Number of events 1 • Adverse events and serious adverse events (SAEs) were recorded from the time the ICF was signed through Day 14.	0.00% 0/48 • Adverse events and serious adverse events (SAEs) were recorded from the time the ICF was signed through Day 14.	0.00% 0/52 • Adverse events and serious adverse events (SAEs) were recorded from the time the ICF was signed through Day 14.
Pregnancy, puerperium and perinatal conditions Pre-eclampsia	1.9% 1/53 • Number of events 1 • Adverse events and serious adverse events (SAEs) were recorded from the time the ICF was signed through Day 14.	0.00% 0/48 • Adverse events and serious adverse events (SAEs) were recorded from the time the ICF was signed through Day 14.	0.00% 0/52 • Adverse events and serious adverse events (SAEs) were recorded from the time the ICF was signed through Day 14.

Other adverse events

Measure	Group 1 (Standard of Care Group) n=53 participants at risk 150 mcg Duramorph® + postoperative multi-modal pain regimen. No EXPAREL TAP infiltration 150 mcg Duramorph + multi-modal pain regimen: Intrathecal injection of 150 mcg Duramorph + multi-modal pain regimen.	Group 2 (Duramorph + EXPAREL TAP) n=48 participants at risk 50 mcg Duramorph + EXPAREL TAP infiltration + postoperative multi-modal pain regimen. 50 mcg Duramorph+ EXPAREL + multi-modal pain regimen: Intrathecal injection of 50 mcg Duramorph + EXPAREL administered via TAP infiltration + multi-modal pain regimen.	Group 3 (EXPAREL TAP) n=52 participants at risk EXPAREL TAP infiltration + postoperative multi-modal pain regimen. No Duramorph. Exparel TAP + multi-modal pain regimen: EXPAREL administered via TAP infiltration + multi-modal pain regimen.
Gastrointestinal disorders Abdominal distention	11.3% 6/53 • Adverse events and serious adverse events (SAEs) were recorded from the time the ICF was signed through Day 14.	12.5% 6/48 • Adverse events and serious adverse events (SAEs) were recorded from the time the ICF was signed through Day 14.	3.8% 2/52 • Adverse events and serious adverse events (SAEs) were recorded from the time the ICF was signed through Day 14.
Gastrointestinal disorders Constipation	11.3% 6/53 • Adverse events and serious adverse events (SAEs) were recorded from the time the ICF was signed through Day 14.	4.2% 2/48 • Adverse events and serious adverse events (SAEs) were recorded from the time the ICF was signed through Day 14.	13.5% 7/52 • Adverse events and serious adverse events (SAEs) were recorded from the time the ICF was signed through Day 14.
Gastrointestinal disorders Flatulence	3.8% 2/53 • Adverse events and serious adverse events (SAEs) were recorded from the time the ICF was signed through Day 14.	0.00% 0/48 • Adverse events and serious adverse events (SAEs) were recorded from the time the ICF was signed through Day 14.	7.7% 4/52 • Adverse events and serious adverse events (SAEs) were recorded from the time the ICF was signed through Day 14.
Gastrointestinal disorders Nausea	30.2% 16/53 • Adverse events and serious adverse events (SAEs) were recorded from the time the ICF was signed through Day 14.	18.8% 9/48 • Adverse events and serious adverse events (SAEs) were recorded from the time the ICF was signed through Day 14.	3.8% 2/52 • Adverse events and serious adverse events (SAEs) were recorded from the time the ICF was signed through Day 14.
Gastrointestinal disorders Vomiting	7.5% 4/53 • Number of events 7 • Adverse events and serious adverse events (SAEs) were recorded from the time the ICF was signed through Day 14.	4.2% 2/48 • Adverse events and serious adverse events (SAEs) were recorded from the time the ICF was signed through Day 14.	0.00% 0/52 • Adverse events and serious adverse events (SAEs) were recorded from the time the ICF was signed through Day 14.
Injury, poisoning and procedural complications Incision site pruritus	1.9% 1/53 • Adverse events and serious adverse events (SAEs) were recorded from the time the ICF was signed through Day 14.	8.3% 4/48 • Adverse events and serious adverse events (SAEs) were recorded from the time the ICF was signed through Day 14.	3.8% 2/52 • Adverse events and serious adverse events (SAEs) were recorded from the time the ICF was signed through Day 14.
Nervous system disorders Dizziness	3.8% 2/53 • Adverse events and serious adverse events (SAEs) were recorded from the time the ICF was signed through Day 14.	8.3% 4/48 • Adverse events and serious adverse events (SAEs) were recorded from the time the ICF was signed through Day 14.	1.9% 1/52 • Adverse events and serious adverse events (SAEs) were recorded from the time the ICF was signed through Day 14.
Nervous system disorders Headache	5.7% 3/53 • Adverse events and serious adverse events (SAEs) were recorded from the time the ICF was signed through Day 14.	2.1% 1/48 • Adverse events and serious adverse events (SAEs) were recorded from the time the ICF was signed through Day 14.	5.8% 3/52 • Adverse events and serious adverse events (SAEs) were recorded from the time the ICF was signed through Day 14.
Skin and subcutaneous tissue disorders Pruritus	47.2% 25/53 • Number of events 74 • Adverse events and serious adverse events (SAEs) were recorded from the time the ICF was signed through Day 14.	58.3% 28/48 • Adverse events and serious adverse events (SAEs) were recorded from the time the ICF was signed through Day 14.	30.8% 16/52 • Adverse events and serious adverse events (SAEs) were recorded from the time the ICF was signed through Day 14.
Skin and subcutaneous tissue disorders Pruritus generalised	17.0% 9/53 • Number of events 20 • Adverse events and serious adverse events (SAEs) were recorded from the time the ICF was signed through Day 14.	12.5% 6/48 • Adverse events and serious adverse events (SAEs) were recorded from the time the ICF was signed through Day 14.	7.7% 4/52 • Adverse events and serious adverse events (SAEs) were recorded from the time the ICF was signed through Day 14.
Skin and subcutaneous tissue disorders Rash	5.7% 3/53 • Adverse events and serious adverse events (SAEs) were recorded from the time the ICF was signed through Day 14.	8.3% 4/48 • Adverse events and serious adverse events (SAEs) were recorded from the time the ICF was signed through Day 14.	0.00% 0/52 • Adverse events and serious adverse events (SAEs) were recorded from the time the ICF was signed through Day 14.

Additional Information

Pacira Medical Information

Pacira Pharmaceuticals, Inc.

Phone: 1-855-793-9727

Email: MedInfo@pacira.com

Results disclosure agreements

• Principal investigator is a sponsor employee Results conducted at Site shall not be published before 1st multicenter publication by Sponsor but can proceed if there is no such publication ≤18 months after study completion/termination at all sites and all data have been received. Before submitting manuscript/materials to an outside person/entity, site shall give Sponsor 60 days to review and comment. Site shall, upon request, further delay publication/presentation for ≤120 days to allow Sponsor to protect its interests in Inventions.
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Restriction type: OTHER