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The purpose of this study is to compare total opioid consumption by subjects in different treatment groups.
Another purpose of this study is to assess how well EXPAREL works, collect any safety data and assess your satisfaction using EXPAREL.
This is a Phase-4, multicenter, randomized, active-controlled study in approximately 182 adult women undergoing elective C-section. All subjects will remain in the hospital for up to 72 hours post surgery.
Subjects will be screened within 30 days prior to surgery. During the screening visit, subjects will be assessed for any past or present medical conditions that in the opinion of the investigator would preclude them from study participation.
After the Informed Consent Form (ICF) is signed, a medical history, surgical history, physical examination, 12-lead electrocardiogram (ECG), vital sign measurements, alcohol breath test and urine drug screen, and clinical laboratory tests (hematology and chemistry) will be performed.
On Day 1, prior to the C-section, eligible subjects will be randomized in a 1:1:1 ratio into one of the three treatment groups listed below:
Rescue Medication will be provided, as needed, for all subjects.
Subjects will remain in the hospital for up to 72 hours after surgery.
Total opioid burden and Pain intensity scores using a 10 cm Visual Analog Scale (VAS) will be collected.
Daily pain intensity score (VAS) and all pain medications will be collected through Day 14.
A phone call will be made to each subject on Day 14 and Day 30.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (Standard of Care Group) | Active Comparator | 150 mcg Duramorph® + postoperative multi-modal pain regimen. No EXPAREL TAP infiltration |
|
| Group 2 (Duramorph + EXPAREL TAP) | Experimental | 50 mcg Duramorph + EXPAREL TAP infiltration + postoperative multi-modal pain regimen. |
|
| Group 3 (EXPAREL TAP) | Experimental | EXPAREL TAP infiltration + postoperative multi-modal pain regimen. No Duramorph. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 50 mcg Duramorph+ EXPAREL + multi-modal pain regimen | Drug | Intrathecal injection of 50 mcg Duramorph + EXPAREL administered via TAP infiltration + multi-modal pain regimen. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Postsurgical Opioid Consumption Through 72 Hours | 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 | Through 72 hours post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Opioid-free Subjects | Percentage of opioid-free subjects. LS Means probability from the logistic regression with treatment, site, age, and height as explanatory variables. | through 72 hours or hospital discharge, whichever came first |
| Severity of Itching (Numeric Rating Scale Score) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nayana Nagaraj, MD, PhD, MPH | Pacira Pharmaceuticals, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States | ||
| University of Florida- Gainesville |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34626927 | Derived | Habib AS, Nedeljkovic SS, Horn JL, Smiley RM, Kett AG, Vallejo MC, Song J, Scranton R, Bao X. Randomized trial of transversus abdominis plane block with liposomal bupivacaine after cesarean delivery with or without intrathecal morphine. J Clin Anesth. 2021 Dec;75:110527. doi: 10.1016/j.jclinane.2021.110527. Epub 2021 Oct 6. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Group 2 (Duramorph + EXPAREL TAP) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 7, 2019 | Jun 27, 2022 |
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| 150 mcg Duramorph + multi-modal pain regimen | Drug | Intrathecal injection of 150 mcg Duramorph + multi-modal pain regimen. |
|
| Exparel TAP + multi-modal pain regimen | Drug | EXPAREL administered via TAP infiltration + multi-modal pain regimen. |
|
Severity of itching (Numeric Rating Scale score from 0(being none)-10(being the worst)) |
| through 72 hours after surgery |
| Opioid Related Symptom Distress Scale Score (ORSDS) | 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. | through 72 hours after surgery |
| Gainesville |
| Florida |
| 32610 |
| United States |
| University of Florida college of Medicine - Jacksonville | Jacksonville | Florida | 32209 | United States |
| Clinical Research Prime | Idaho Falls | Idaho | 83404 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08901 | United States |
| St. Peter's University Medical Center | New Brunswick | New Jersey | 08901 | United States |
| Columbia University Medical Center/NY Presbyterian Hospital | New York | New York | 10032 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| Thomas Jefferson Medical Center | Philadelphia | Pennsylvania | 19107 | United States |
| Magee-Women's Hospital of UPMC | Pittsburgh | Pennsylvania | 15213 | United States |
| The University of Texas Medical Branch | Galveston | Texas | 77555-0877 | United States |
| Inova Health System | Falls Church | Virginia | 22042 | United States |
| West Virginia University | Morgantown | West Virginia | 86506 | United States |
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. |
| FG002 | 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| American Society of Anesthesiologists (ASA) Physical Status Classification | ASA I: normal, healthy patient ASA II: mild systemic disease ASA III Severe systemic disease that is not life threatening ASA IV: Severe systemic disease that is a constant threat to life | Count of Participants | Participants |
| |||||||||||||||
| Body Mass Index (pre-pregnancy) | Mean | Standard Deviation | kg/m^2 |
|
| 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 Postsurgical Opioid Consumption Through 72 Hours | 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 | Posted | Least Squares Mean | Standard Error | OMED mg | Through 72 hours post-surgery |
|
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| ||||||||||||||||||||||||||||||||
| Secondary | Percentage of Opioid-free Subjects | Percentage of opioid-free subjects. LS Means probability from the logistic regression with treatment, site, age, and height as explanatory variables. | LS Means probability from the logistic regression with treatment, site, age, and height as explanatory variables. | Posted | Number | percentage of participants, opioid free | through 72 hours or hospital discharge, whichever came first |
| ||||||||||||||||||||||||||||||||||
| Secondary | Severity of Itching (Numeric Rating Scale Score) | Severity of itching (Numeric Rating Scale score from 0(being none)-10(being the worst)) | Posted | Least Squares Mean | Standard Error | score on a scale | through 72 hours after surgery |
| ||||||||||||||||||||||||||||||||||
| Secondary | Opioid Related Symptom Distress Scale Score (ORSDS) | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | through 72 hours after surgery |
|
Adverse events and serious adverse events (SAEs) were recorded from the time the ICF was signed through Day 14.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 53 | 2 | 53 | 43 | 53 |
| EG001 | 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. | 0 | 48 | 2 | 48 | 41 | 48 |
| EG002 | 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. | 0 | 52 | 2 | 52 | 30 | 52 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Postpartum hemorrhage | Injury, poisoning and procedural complications | MedDRA 21.1 | Non-systematic Assessment |
| |
| Abdominal wall hematoma | Injury, poisoning and procedural complications | MedDRA 21.1 | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Incision Site Pain | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Pre-eclampsia | Pregnancy, puerperium and perinatal conditions | MedDRA 21.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distention | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Incision site pruritus | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pacira Medical Information | Pacira Pharmaceuticals, Inc. | 1-855-793-9727 | MedInfo@pacira.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 16, 2020 | Jan 26, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009020 | Morphine |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| ASA II |
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| ASA III |
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