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Post C-Section Pain Control Using EXPAREL

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03377595
Recruitment Status : Recruiting
First Posted : December 19, 2017
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Brief Summary:
Evaluating the safety and efficacy of EXPAREL (Liposomal Bupivacaine ) for pain control in patients undergoing scheduled cesarean section by giving it either as infiltration in Transversus Abdominis Plane after finishing the procedure or through wound infiltration into the fascia prior to closure of skin

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: Exparel Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Post-cesarean Section Analgesic Safety and Efficacy of EXPAREL (Liposomal Bupivacaine) Infiltration Locally Versus Transversus Abdominis Plane Infiltration
Actual Study Start Date : July 2, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Experimental: TAP (Transversus Abdominis Plane) block
20-mL dose of EXPAREL 266 mg expanded in volume with 20 mL normal saline plus 20 mL 0.25% bupivacaine for a total volume of 60 mL m.A 2-point classic TAP block will be performed under ultrasound guidance within 1 hour (± 30 minutes) following skin incision closure of the C-section.
Drug: Exparel
TAP (Transversus Abdominis Plane) block
Other Name: Saline

Experimental: Wound infiltration
20 mL of EXPAREL 266 mg expanded in volume with 40 mL normal saline for a total volume of 60 mL, infiltrated in the fascia prior to skin closure with attention to infiltrate the angles of the incision.
Drug: Exparel
Wound infiltration
Other Name: Saline




Primary Outcome Measures :
  1. Total opioid consumption [ Time Frame: 72 hours ]
    Total opioid medication use by patient after having cesarean section


Secondary Outcome Measures :
  1. Time to first rescue opioid pain medication [ Time Frame: 72 hours ]
    Time till the patient asks for opioid medication for breakthrough pain

  2. Percentage of opioid-free subjects [ Time Frame: 24,48, and 72 hours ]
    Percentage of patients didn't require any opioid medications after the cesarean section

  3. Patient's satisfaction [ Time Frame: through 72 hours post-op or at discharge ]
    Patient's satisfaction questionnaire with pain control

  4. VAS (visual analogue scale) pain scores [ Time Frame: at 6, 12, 18, 24, 30, 36, 42, 48, and 72 hours after surgery ]
    pain level assessment using visual assessment pain score which ranges from zero for no pain to 10 intolerable pain

  5. Number of participants with EXPAREL related adverse events [ Time Frame: through day 14 post-op ]
    side effects of EXPAREL

  6. Allergic reactions attributable to local anesthetic use [ Time Frame: through day14 post-op ]
    Such as allergies, rash etc...

  7. Wound complications [ Time Frame: through day 14 post-op ]
    cesarean section wound complications like infection, hematoma, and dehiscence



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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. ASA (American Society of Anesthesiologists) physical status 1, 2, or 3 are able to provide informed consent, adhere to the study visit schedule, and complete all study assessments

Exclusion Criteria:

  1. Age <18
  2. BMI > or equal to 40 or otherwise not anatomically appropriate to undergo a TAP block.
  3. Planned general anesthetic
  4. Cesarean delivery via vertical skin incision
  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 (eg, serum creatinine level >2 mg/dL [176.8 µmol/L], blood urea nitrogen level >50 mg/dL [17.9 mmol/L], serum aspartate aminotransferase [AST] level >3 times the upper limit of normal , or serum alanine aminotransferase [ALT] level >3 times the upper limit of normal.)
  8. Subjects at an increased risk for bleeding or a coagulation disorder (defined as platelet count less than 80, 000 × 103/mm3 or international normalized ratio greater than 1.5).
  9. Concurrent painful physical condition that may require analgesic treatment (such as long-term, consistent use of opioids) in the postsurgical period for pain that is not strictly related to the surgery and which may confound the postsurgical assessments.
  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. This includes any psychiatric or other disease in the mother that would constitute a contraindication to participation in the study or cause the mother to be unable to comply with the study requirements.
  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, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study
  13. Previous participation in an EXPAREL study.
  14. Any clinically significant event or condition uncovered during the surgery (eg, excessive bleeding, acute sepsis) that might render the subject medically unstable or complicate the subject's postsurgical course.
  15. 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.
  16. 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.

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): NCT03377595


Contacts
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Contact: Hiba Mustafa, MD 8324754061 musta062@umn.edu

Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Hiba Mustafa, MD    832-475-4061    musta062@umn.edu   
Sponsors and Collaborators
University of Minnesota
Investigators
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Principal Investigator: Hiba Mustafa, MD University of Minnesota
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT03377595    
Other Study ID Numbers: 1234
First Posted: December 19, 2017    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019
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
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms