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Evaluation of the Safety and Efficacy of EXPAREL When Administered Into the TAP in Subjects Undergoing Cesarean Section

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: NCT02353754
Recruitment Status : Terminated (Slow enrollment. None of the subjects received EXPAREL.)
First Posted : February 3, 2015
Results First Posted : June 28, 2016
Last Update Posted : June 28, 2016
Sponsor:
Information provided by (Responsible Party):
Pacira Pharmaceuticals, Inc

Brief Summary:
This is a Phase 4, multicenter, open-label study evaluating EXPAREL infiltration into the transversus abdominis plane (TAP) after bupivacaine hydrochloride (HCl) spinal anesthesia in subjects undergoing elective Cesarean section (C-section).

Condition or disease Intervention/treatment Phase
Pain Drug: Intrathecal morphine injection Drug: EXPAREL Phase 4

Detailed Description:
There will be two groups of subjects with approximately 40 subjects per group. Prior to the C-section, all subjects will receive single-shot spinal anesthesia (1.5 mL bupivacaine HCl 0.75% with dextrose 8.25%). Subjects in Group 1 (Standard of Care) will receive intrathecal morphine injection (e.g., Duramorph®) 0.2 mg in conjunction with the single-shot spinal anesthesia. No TAP block will be administered. Subjects in Group 2 (EXPAREL/TAP) will receive a bilateral TAP infiltration with a single 20 mL dose of EXPAREL 266 mg expanded in volume with 20 mL of normal saline for a total volume of 40 mL (20 mL infiltrated on each side of the abdomen).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of EXPAREL When Administered Via Infiltration Into the Transversus Abdominis Plane (TAP) After Bupivacaine Spinal Anesthesia in Subjects Undergoing Elective Cesarean Section
Study Start Date : May 2015
Actual Primary Completion Date : June 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Active Comparator: Standard of Care
Subjects in Group 1 (Standard of Care) will receive intrathecal morphine injection (e.g., Duramorph®) 0.2 mg in conjunction with the single-shot spinal anesthesia. No TAP block will be administered.
Drug: Intrathecal morphine injection
0.2 mg
Other Name: Duramorph

Experimental: EXPAREL/TAP
Subjects in Group 2 will receive a bilateral TAP infiltration with a single 20 mL dose of EXPAREL 266 mg expanded in volume with 20 mL of normal saline for a total volume of 40 mL (20 mL infiltrated on each side of the abdomen).
Drug: EXPAREL
266 mg
Other Name: Bupivacaine liposome injectable suspension




Primary Outcome Measures :
  1. Total Postsurgical Narcotic Consumption in Morphine Equivalents [ Time Frame: Through 72 hours postdose ]
    Outcome measure data refer to 7 participants who received rescue medication


Secondary Outcome Measures :
  1. Total Postsurgical Narcotic Consumption in Morphine Equivalents [ Time Frame: Through 24 hours ]
    Outcome measure data refer to 6 participants who received rescue medication

  2. Total Postsurgical Narcotic Consumption in Morphine Equivalents [ Time Frame: Through 48 hours ]
    Outcome measure data refer to 7 participants who received rescue medication



Information from the National Library of Medicine

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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 at screening.
  2. Scheduled to undergo elective C-section (single or multiple births).
  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. History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics or opioids.
  2. Contraindication to bupivacaine, morphine, ketorolac, ibuprofen, or acetaminophen.
  3. Planned concurrent surgical procedure with the exception of salpingo-oophorectomy or tubal ligation.
  4. Use of any of the following medications within the times specified before surgery: long-acting opioid medication, non-steroidal anti-inflammatory drugs (NSAIDs), or aspirin (except for low-dose aspirin used for cardioprotection) within 3 days, or any opioid medication or acetaminophen within 24 hours.
  5. Initiation of treatment with any of the following medications within 1 month of study drug administration or if the medication(s) are being given to control pain: selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), gabapentin, pregabalin (Lyrica®), or duloxetine (Cymbalta®). If a subject is taking one of these medications for a reason other than pain control, she must be on a stable dose for at least 1 month prior to study drug administration.
  6. Clinically significant medical or psychiatric disease that, in the opinion of the Investigator, would constitute a contraindication to participation in the study or cause inability to comply with the study requirements.
  7. History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medication(s), or alcohol within the past 2 years.
  8. Received an investigational drug within 30 days prior to study drug administration, and/or has planned administration of another investigational product or procedure while participating in this study.
  9. Previous participating in an EXPAREL study.

    The subject will be withdrawn from the study if she meets the following criteria:

  10. Any clinically significant event or condition uncovered during the surgery (e.g., excessive bleeding, acute sepsis) that might render the subject medically unstable or complicate the subject's postsurgical course.
  11. Her baby's 5-minute Apgar score is ≤7.

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): NCT02353754


Locations
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United States, Florida
Tradition Medical Center
Port St. Lucie, Florida, United States, 34987
United States, Minnesota
University Of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, New Jersey
Saint Peter's University Hospital
New Brunswick, New Jersey, United States, 08901
United States, New York
Montefiore
Bronx, New York, United States, 10467
United States, Ohio
The Ohio State University, Wexner Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Pacira Pharmaceuticals, Inc
Investigators
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Study Director: Erol Onel, MD Pacira Pharmaceuticals, Inc

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Responsible Party: Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT02353754    
Other Study ID Numbers: 402-C-402
First Posted: February 3, 2015    Key Record Dates
Results First Posted: June 28, 2016
Last Update Posted: June 28, 2016
Last Verified: July 2015
Additional relevant MeSH terms:
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Morphine
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics