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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03853694
Recruitment Status : Completed
First Posted : February 26, 2019
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Pacira Pharmaceuticals, Inc

Brief 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.


Condition or disease Intervention/treatment Phase
Elective Cesarean Section Pain Management Drug: 50 mcg Duramorph+ EXPAREL + multi-modal pain regimen Drug: 150 mcg Duramorph + multi-modal pain regimen Drug: Exparel TAP + multi-modal pain regimen Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 167 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : March 4, 2019
Actual Primary Completion Date : January 9, 2020
Actual Study Completion Date : January 9, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Active Comparator: Group 1 (Standard of Care Group)
150 mcg Duramorph® + postoperative multi-modal pain regimen. No EXPAREL TAP infiltration
Drug: 150 mcg Duramorph + multi-modal pain regimen
Intrathecal injection of 150 mcg Duramorph + multi-modal pain regimen.

Experimental: Group 2 (Duramorph + EXPAREL TAP)
50 mcg Duramorph + EXPAREL TAP infiltration + postoperative multi-modal pain regimen.
Drug: 50 mcg Duramorph+ EXPAREL + multi-modal pain regimen
Intrathecal injection of 50 mcg Duramorph + EXPAREL administered via TAP infiltration + multi-modal pain regimen.

Experimental: Group 3 (EXPAREL TAP)
EXPAREL TAP infiltration + postoperative multi-modal pain regimen. No Duramorph.
Drug: Exparel TAP + multi-modal pain regimen
EXPAREL administered via TAP infiltration + multi-modal pain regimen.




Primary Outcome Measures :
  1. Total Postsurgical Opioid Consumption (Morphine Equivalent Dose (MED)) [ Time Frame: Through 72 hours post-surgery ]

Secondary Outcome Measures :
  1. Time to first postsurgical opioid rescue medication [ Time Frame: Through 72 hours post-surgery ]
    Time to first postsurgical opioid rescue medication (days)

  2. Percentage of opioid-free subjects [ Time Frame: through 72 hours or hospital discharge ]
    Percentage of opioid-free subjects

  3. Incidence and severity of itching (Numeric Rating Scale score) [ Time Frame: through 72 hours after surgery ]
    Incidence and severity of itching (Numeric Rating Scale score from 0(being none)-10(being the worst))

  4. Opioid Related Symptom Distress scale score (ORSDS) [ Time Frame: through 72 hours after surgery ]
    Opioid Related Symptom Distress scale score (ORSDS) - a multi-question assessment total

  5. The VAS (Visual Acuity Scale) [ Time Frame: through 72 hours after surgery ]
    The VAS (Visual Acuity Scale) (numerical rating scale from 0 (being none)-10 (being the worst) pain

  6. Number of Adverse Events (AEs) -Total [ Time Frame: through Day 14 ]
    Number of Adverse Events (AEs) -Total

  7. Number of Serious Adverse Events (SAEs)-Total [ Time Frame: through Day 14 ]
    Number of Serious Adverse Events (SAEs)-Total



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Females 18 years of age and older at screening.
  2. Term pregnancies of 37 to 42 weeks gestation, scheduled to undergo elective C-section.
  3. American Society of Anesthesiology (ASA) physical status 1, 2, or 3.
  4. Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments.

Exclusion Criteria:

  1. Subjects who, in the opinion of the study site principal investigator, have a high-risk pregnancy.
  2. Subjects with a pregnancy-induced medical condition or complication.
  3. Subjects with 3 or more prior C-sections.
  4. Pre-pregnancy body mass index >50 kg/m2.
  5. Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications.
  6. Planned concurrent surgical procedure with the exception of salpingo-oophorectomy or tubal ligation.
  7. Severely impaired renal or hepatic function.
  8. Subjects at an increased risk for bleeding or a coagulation disorder.
  9. Concurrent painful physical condition that may require analgesic treatment in the postsurgical period for pain that is not strictly related to the surgery.
  10. 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.
  11. History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
  12. Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug.
  13. Previous participation in an EXPAREL study.
  14. Any clinically significant event or condition uncovered during the surgery that might render the subject medically unstable or complicate the subject's postsurgical course.
  15. Receives the epidural component of combined spinal epidural (CSE) anesthesia during the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03853694


Locations
Show Show 18 study locations
Sponsors and Collaborators
Pacira Pharmaceuticals, Inc
Investigators
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Study Director: Igor Grachev, MD, PhD Pacira Pharmaceuticals, Inc

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Responsible Party: Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT03853694    
Other Study ID Numbers: 402-C-414
First Posted: February 26, 2019    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pacira Pharmaceuticals, Inc:
bupivacaine
EXPAREL
analgesic
TAP Block
C-Section
Cesarean Section
elective c-section
TAP
Additional relevant MeSH terms:
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Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents