Elective Cesarean SectionPhase 4CHOICENCT03853694
Efficacy and Safety of EXPAREL Versus Standard of Care (SoC) in Subjects Undergoing Elective Cesarean Section
A Phase 4 study testing 50 mcg Duramorph+ EXPAREL + multi-modal pain regimen, 150 mcg Duramorph + multi-modal pain regimen and Exparel TAP + multi-modal pain regimen in people with Elective Cesarean Section and Pain Management, run by Pacira Pharmaceuticals, Inc at 18 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Elective Cesarean Section, Pain Management
- What is being tested?
- 50 mcg Duramorph+ EXPAREL + multi-modal pain regimen, 150 mcg Duramorph + multi-modal pain regimen and Exparel TAP + multi-modal pain regimen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 18 sitesUnited States
- Study dates
- 4 Mar 2019to 16 Jan 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females 18 years of age and older at screening.
- Term pregnancies of 37 to 42 weeks gestation, scheduled to undergo elective C-section.
- American Society of Anesthesiology (ASA) physical status 1, 2, or 3.
- Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments.
Who cannot join
- Subjects who, in the opinion of the study site principal investigator, have a high-risk pregnancy.
- Subjects with a pregnancy-induced medical condition or complication.
- Subjects with 3 or more prior C-sections.
- Pre-pregnancy body mass index >50 kg/m2.
- Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications.
- Planned concurrent surgical procedure with the exception of salpingo-oophorectomy or tubal ligation.
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- Severely impaired renal or hepatic function.
- Subjects at an increased risk for bleeding or a coagulation disorder.
- Concurrent painful physical condition that may require analgesic treatment in the postsurgical period for pain that is not strictly related to the surgery.
- Clinically significant medical disease in either the mother or baby that, in the opinion of the investigator, would make participation in a clinical study inappropriate.
- History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
- Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug.
- Previous participation in an EXPAREL study.
- Any clinically significant event or condition uncovered during the surgery that might render the subject medically unstable or complicate the subject's postsurgical course.
- Receives the epidural component of combined spinal epidural (CSE) anesthesia during the study.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Cleveland Clinic
Cleveland, Ohio, 44195
Ohio State University
Columbus, Ohio, 43210
Henry Ford Hospital
Detroit, Michigan, 48202
Duke University Medical Center
Durham, North Carolina, 27710
Inova Health System
Falls Church, Virginia, 22042
University of Florida- Gainesville
Gainesville, Florida, 32610
The University of Texas Medical Branch
Galveston, Texas, 77555-0877
Clinical Research Prime
Idaho Falls, Idaho, 83404
University of Florida college of Medicine - Jacksonville
Jacksonville, Florida, 32209
West Virginia University
Morgantown, West Virginia, 86506
Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
St. Peter's University Medical Center
New Brunswick, New Jersey, 08901
Columbia University Medical Center/NY Presbyterian Hospital
New York, New York, 10032
Thomas Jefferson Medical Center
Philadelphia, Pennsylvania, 19107
Magee-Women's Hospital of UPMC
Pittsburgh, Pennsylvania, 15213
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: A Multicenter, Randomized, Active-Controlled Study to Evaluate the Efficacy and Safety of EXPAREL When Administered Via Infiltration Into the Transversus Abdominis Plane Versus Standard of Care in Subjects Undergoing Elective Cesarean Section (CHOICE)
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.
Read the detailed description
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:
- Group 1: 150 mcg Duramorph® (SOC arm)+ postoperative multi-modal pain regimen as defined in this protocol. No EXPAREL TAP infiltration following skin-incision closure.
- Group 2: 50 mcg Duramorph + EXPAREL TAP infiltration following skin-incision closure + postoperative multi-modal pain regimen as defined in this protocol.
- Group 3: EXPAREL TAP infiltration following skin-incision closure + postoperative multi-modal pain regimen as defined in this protocol. No Duramorph.
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.
- Conditions
- Elective Cesarean Section, Pain Management
- Being tested
- 50 mcg Duramorph+ EXPAREL + multi-modal pain regimen, 150 mcg Duramorph + multi-modal pain regimen, Exparel TAP + multi-modal pain regimen
- Keywords
- bupivacaine, EXPAREL, analgesic, TAP Block, C-Section, Cesarean Section, elective c-section, TAP
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
50 mcg Duramorph+ EXPAREL + multi-modal pain regimenDrug
Intrathecal injection of 50 mcg Duramorph + EXPAREL administered via TAP infiltration + multi-modal pain regimen.
150 mcg Duramorph + multi-modal pain regimenDrug
Intrathecal injection of 150 mcg Duramorph + multi-modal pain regimen.
Exparel TAP + multi-modal pain regimenDrug
EXPAREL administered via TAP infiltration + multi-modal pain regimen.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Standard of Care Group) | Active comparator | 150 mcg Duramorph® + postoperative multi-modal pain regimen. No EXPAREL TAP infiltration Receives: Drug: 150 mcg Duramorph + multi-modal pain regimen |
| Group 2 (Duramorph + EXPAREL TAP) | Experimental | 50 mcg Duramorph + EXPAREL TAP infiltration + postoperative multi-modal pain regimen. Receives: Drug: 50 mcg Duramorph+ EXPAREL + multi-modal pain regimen |
| Group 3 (EXPAREL TAP) | Experimental | EXPAREL TAP infiltration + postoperative multi-modal pain regimen. No Duramorph. Receives: Drug: Exparel TAP + multi-modal pain regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through 72 hours post-surgery
Secondary outcomes (3)
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.
Measured: through 72 hours or hospital discharge, whichever came first
Severity of Itching (Numeric Rating Scale Score)
Severity of itching (Numeric Rating Scale score from 0(being none)-10(being the worst))
Measured: 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.
Measured: through 72 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start4 Mar 2019
- Primary completion9 Jan 2020
- Study completion16 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Elective Cesarean SectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacira Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nayana Nagaraj, MD, PhD, MPH, Study director, Pacira Pharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03853694
- Sponsor's protocol ID
- 402-C-414
- Acronym
- CHOICE
- Status last verified
- Jul 2022
- First submitted
- 19 Sep 2018
- Last updated
- 18 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34626927
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Active-Controlled Study to Evaluate the Efficacy and Safety of EXPAREL When Administered Via Infiltration Into the Transversus Abdominis Plane Versus Standard of Care in Subjects Undergoing Elective Cesarean Section (CHOICE)
- ClinicalTrials.gov ID
- NCT03853694
- Acronym / sponsor ID
- CHOICE / 402-C-414
- Conditions
- Elective Cesarean Section, Pain Management
- Keywords
- bupivacaine, EXPAREL, analgesic, TAP Block, C-Section, Cesarean Section, elective c-section, TAP
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Pacira Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- 4 Mar 2019 (actual)
- Primary completion
- 9 Jan 2020 (actual)
- Study completion
- 16 Jan 2020 (actual)
- First posted
- 26 Feb 2019 (actual)
- Results
- Posted 18 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Group 1: 150 mcg Duramorph® (SOC arm)+ postoperative multi-modal pain regimen as defined in this protocol. No EXPAREL TAP infiltration following skin-incision closure.
- Group 2: 50 mcg Duramorph + EXPAREL TAP infiltration following skin-incision closure + postoperative multi-modal pain regimen as defined in this protocol.
- Group 3: EXPAREL TAP infiltration following skin-incision closure + postoperative multi-modal pain regimen as defined in this protocol. No Duramorph.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Standard of Care Group) | Active comparator | Drug: 150 mcg Duramorph + multi-modal pain regimen150 mcg Duramorph® + postoperative multi-modal pain regimen. No EXPAREL TAP infiltration |
| Group 2 (Duramorph + EXPAREL TAP) | Experimental | Drug: 50 mcg Duramorph+ EXPAREL + multi-modal pain regimen50 mcg Duramorph + EXPAREL TAP infiltration + postoperative multi-modal pain regimen. |
| Group 3 (EXPAREL TAP) | Experimental | Drug: Exparel TAP + multi-modal pain regimenEXPAREL TAP infiltration + postoperative multi-modal pain regimen. No Duramorph. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Females 18 years of age and older at screening.
- Term pregnancies of 37 to 42 weeks gestation, scheduled to undergo elective C-section.
- American Society of Anesthesiology (ASA) physical status 1, 2, or 3.
- Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments.
Key exclusion criteria (15 listed)
- Subjects who, in the opinion of the study site principal investigator, have a high-risk pregnancy.
- Subjects with a pregnancy-induced medical condition or complication.
- Subjects with 3 or more prior C-sections.
- Pre-pregnancy body mass index >50 kg/m2.
- Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 50 mcg Duramorph+ EXPAREL + multi-modal pain regimenIntrathecal injection of 50 mcg Duramorph + EXPAREL administered via TAP infiltration + multi-modal pain regimen. | Drug | Group 2 (Duramorph + EXPAREL TAP) |
| 150 mcg Duramorph + multi-modal pain regimenIntrathecal injection of 150 mcg Duramorph + multi-modal pain regimen. | Drug | Group 1 (Standard of Care Group) |
| Exparel TAP + multi-modal pain regimenEXPAREL administered via TAP infiltration + multi-modal pain regimen. | Drug | Group 3 (EXPAREL TAP) |
Primary outcome
Total Postsurgical Opioid Consumption Through 72 Hours
Time frame: 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
3 secondary outcomes
Percentage of Opioid-free Subjects
Time frame: through 72 hours or hospital discharge, whichever came first
Severity of Itching (Numeric Rating Scale Score)
Time frame: through 72 hours after surgery
Opioid Related Symptom Distress Scale Score (ORSDS)
Time frame: through 72 hours after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34626927Habib 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nayana Nagaraj, MD, PhD, MPH study director
Pacira Pharmaceuticals, Inc
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 50 mcg Duramorph+ EXPAREL + multi-modal pain regimen, 150 mcg Duramorph + multi-modal pain regimen and Exparel TAP + multi-modal pain regimen in people with Elective Cesarean Section and Pain Management, run by Pacira Pharmaceuticals, Inc at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Postsurgical Opioid Consumption Through 72 Hours (time frame: Through 72 hours post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03853694, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2022.