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EXPAREL for Minimally Invasive Supracervical Hysterectomies

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ClinicalTrials.gov Identifier: NCT03769714
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
Pedram Bral, Maimonides Medical Center

Brief Summary:

The aim of the of the study is a reduction in minimally invasive supracervical hysterectomy postsurgical pain, which may result in less need for supplemental opioid pain medications, fewer opioid related adverse events, and a better recovery experience for patients, which may offer an economic benefit to health care systems.

Intracervical preoperative dose of Exparel during minimally invasive (robotic--assisted or traditional laparoscopy) supracervical hysterectomy reduces cumulative pain scores for up to 24 hours and reduces overall requests for break through (additional) analgesia with opioid consumption compared with placebo.


Condition or disease Intervention/treatment Phase
Pain Drug: Saline Solution for Injection Drug: Exparel Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Placebo-controlled, Double-blinded, Randomized Pilot Study of Bupivacaine Liposome Injectable Suspension (EXPAREL) for Minimally Invasive Supracervical Hysterectomies Postsurgical Analgesia
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy

Arm Intervention/treatment
Active Comparator: Saline Solution for Injection
Group A (control, n=26) to receive 20ml of saline while prepping. The syringe will covered as to disguise the contents of the syringe.
Drug: Saline Solution for Injection
Injection of 20mL of 0.9%Normal Saline
Other Name: Standard

Experimental: Exparel
Group B (study, n=26) to receive 20ml of liposomal bupivacaine (EXPAREL) into the stroma of the cervix at the 4 and 8 o'clock positions (innervation insertion points of the cervix).
Drug: Exparel
Exparel (bupivacaine liposome injectable suspension) is a liposome injection of bupivacaine, an amide-type local anesthetic, indicated (bupivacaine liposome injectable suspension) for administration into the surgical site to produce postsurgical analgesia.
Other Name: liposomal bupivicaine




Primary Outcome Measures :
  1. Pain at 12 hours [ Time Frame: 12 hours after surgery ]
    Participant will be shown a card that has a visual analogue (Faces) pains scale combined with numerical (0-10) analogue scale (0 is no pain, 10 is the worst pain imaginable).at 12 hours postoperatively

  2. Pain at 24 hours [ Time Frame: 24 hours after surgey ]
    Participant will be shown a card that has a visual analogue (Faces) pains scale combined with numerical (0-10) analogue scale (0 is no pain, 10 is the worst pain imaginable).at 24 hours postoperatively

  3. Painat 48 hours [ Time Frame: 48 hours after surgery ]
    Participant will be shown a card that has a visual analogue (Faces) pains scale combined with numerical (0-10) analogue scale (0 is no pain, 10 is the worst pain imaginable) at 48 hours postoperatively


Secondary Outcome Measures :
  1. Patients with additional pain medications [ Time Frame: 48 hours ]
    Number of patients who required additional pain medications



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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 35--75 years of age at the Screening Visit.
  2. Female subjects only.
  3. Scheduled to undergo minimally invasive (robotic-assisted or laparoscopic) supracervical hysterectomy, under general anesthesia.
  4. Clinical laboratory values less than twice the upper limit of normal or, if abnormal, deemed not clinically significant per the Investigator.
  5. Ability to provide informed consent, adhere to the study visit schedule and complete all study assessments and language specific questionnaires.

Exclusion Criteria:

  1. Currently pregnant, nursing, or planning to become pregnant.
  2. Use of any of the following medications within the times specified before surgery: a. opioid, SSRI, tricyclic antidepressant, gabapentin, pregabalin within three days of surgery. b. Use of acetaminophen within 24 hours of surgery.
  3. Concurrent painful physical condition or concurrent surgery that may require analgesic treatment (such as NSAID, opioid, SSRI, tricyclic antidepressant, gabapentin, pregabalin) in the postoperative period for pain that is not strictly related to the minimally invasive supracervical hysterectomy procedure and may confound the postoperative assessments (e.g., rheumatoid arthritis, chronic neuropathic pain.
  4. Chronic user of analgesic medications, including taking opioid medications for more than 14 days in the last 3 months, or non-opioid pain medications more than 5 times per week.
  5. Current use of systemic glucocorticosteroids (e.g. Decadron) or use of glucocorticoids within one month of enrollment into this study.
  6. History of hepatitis (other than hepatitis A).
  7. History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
  8. Failure of presurgical drug and alcohol screen.
  9. History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics, opioids, or propofol.
  10. Administration of an investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study.

12. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the Investigator, may interfere with study assessments or compliance. 13. Significant medical conditions or laboratory results that, in the opinion of the Investigator indicate an increased vulnerability to study drug and procedures, and expose subjects to an unreasonable risk as a result of participating in this clinical trial. 14. 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 postoperative course. 15. An incision length greater than 3 cm.


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): NCT03769714


Contacts
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Contact: Mary Ann H Son, M.D. 6465263287 sonmaryann@gmail.com
Contact: Camilla Paiva, M.D. 954 496 1275 Cpaiva@maimonidesmed.org

Locations
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United States, New York
Maimonides Medical Center Recruiting
Brooklyn, New York, United States, 11219
Contact: Mary Ann Son, MD       mson@maimonidesmed.org   
Contact: Pedram Bral, MD       pbral@maimonidesmed.org   
Sponsors and Collaborators
Maimonides Medical Center
Investigators
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Principal Investigator: Pedram Bral, M.D. Minimally Invasive Surgery -Fellowship Director

Publications of Results:

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Responsible Party: Pedram Bral, Minimally Invasive Surgery Program Director, Maimonides Medical Center
ClinicalTrials.gov Identifier: NCT03769714     History of Changes
Other Study ID Numbers: 2018-02-12-MMC
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018

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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.: No

Keywords provided by Pedram Bral, Maimonides Medical Center:
laparoscopy
supracervical hysterectomy
Multimodal pain management
bupivacaine liposome
Exparel

Additional relevant MeSH terms:
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Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents