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Liposomal Bupivacaine After Cesarean Delivery

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: NCT03907813
Recruitment Status : Withdrawn (change in design)
First Posted : April 9, 2019
Last Update Posted : July 31, 2020
Sponsor:
Information provided by (Responsible Party):
Marilyn J Kindig, D.O., Wright State University

Brief Summary:
The aim of this study is to determine if local wound infiltration with liposomal bupivacaine at the time of cesarean delivery can decrease opioid use and provide adequate post-operative pain control.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Opioid Use Drug: Exparel Other: Saline infiltration Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, controlled, double blind trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: double blind
Primary Purpose: Treatment
Official Title: The Effect of Local Infiltration of Liposomal Bupivacaine on Opioid Consumption at Time of Cesarean Delivery: A Randomized Controlled Trial
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Experimental: liposomal bupivacaine infiltration
Local infiltration of all wound layers with liposomal bupivacaine (Exparel(R)) 20 ml diluted with 70 ml of normal saline to 90 ml for patient with a BMI of 39 and under. If BMI is 40 or more the 20 ml of liposomal bupivicaine will be diluted to 150 ml by adding 130 ml of normal saline
Drug: Exparel
liposomal bupivacaine wound infiltration
Other Name: liposomal bupivacaine

Placebo Comparator: Saline infiltration
Local infiltration of all wound layers with saline, using to match the amount. The amount of total fluid is divided into 4 and instilled with 1-2 ml at a time in between fascial layers after fascial closure. Each 1/4 will be instilled laterally (2) and on each side of the incision(2)- extra fluid is placed subcutaneously.
Other: Saline infiltration
saline wound infiltration




Primary Outcome Measures :
  1. Opioid (narcotic medication) use [ Time Frame: at the end of 48 hours after delivery ]
    total opioid use, as morphine equivalents; sum of narcotic pain medications over 48 hours reported in morphine equivalents, by the Ohio Automated RX reporting system calculator, where hydrocodone 5 mg is 5 morphine equivalent dose (MED) and percocet 5 is 7.5 MED


Secondary Outcome Measures :
  1. Average pain scores Day 1 [ Time Frame: at the end of 24 hours after delivery ]
    Patient reported pain scores (0-10 where ten is the highest possible and 0 is no pain) as recorded by nursing staff, average post delivery in recovery and up to 23 hours and 59 minutes.

  2. Average pain scores Day 2 [ Time Frame: at the end of 48 hours after delivery ]
    Patient reported pain scores (0-10 where ten is the highest possible and 0 is no pain) as recorded by nursing staff, average from 24 hours to 48 hours.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant women delivering by scheduled cesarean delivery
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Are between 18 and 45 years of age, inclusive.
  • Are undergoing a planned, primary or repeat, cesarean delivery without permanent sterilization.
  • Have a BMI ≤ 60.
  • Are able to read and understand English.

Exclusion Criteria:

  • Have pre-eclampsia with severe features.
  • Has been taking medication assisted treatment for opioid addiction during this pregnancy.
  • Have known sensitivity to local anesthetic.
  • Have a known sensitivity to non-steroidal anti-inflammatory medications.
  • Planning to have a tubal ligation after the cesarean delivery.
  • Are unable to receive neuraxial analgesia and/or Duramorph, a morphine formulation that is the standard of care for intrathecal anesthesia at MVH.
  • Are prisoners.

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): NCT03907813


Locations
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United States, Ohio
Miami Valley Hospital
Dayton, Ohio, United States, 45409
Sponsors and Collaborators
Wright State University
Investigators
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Principal Investigator: Marilyn Kindig, DO Wright State University
Publications:
Yaklic JL; Maxwell RA; Urschel K; Robinson S; Dearmond MK; Lindheim SR Effect of Continuous Local Anesthetic Use for Pain Control and Narcotic Use After Cesarean Section: A Randomized Trial. Open J Surg. 2017; 1(1): 026-030
State of Ohio Board of Pharmacy 2019. OARRS Rules Update - Spring 2019; Rules Update - Drug Distributors - Spring 2019; Rules Update - Terminal Distributors - Spring 2019; 2018. 2nd and 3rd Quarter - Rule Update pharmacy.ohio.gov

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Responsible Party: Marilyn J Kindig, D.O., Assistant Professor, Wright State University
ClinicalTrials.gov Identifier: NCT03907813    
Other Study ID Numbers: Kindig-Williams-001
First Posted: April 9, 2019    Key Record Dates
Last Update Posted: July 31, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be shared on a case by case basis.

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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
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents