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Sternal Block With Liposomal Bupivacaine vs. Saline Prior to Incision in Cardiac Surgery

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. Identifier: NCT04333095
Recruitment Status : Recruiting
First Posted : April 3, 2020
Last Update Posted : January 27, 2021
Information provided by (Responsible Party):
Baylor Research Institute

Brief Summary:
The purpose of this study is to find out what effects (good and bad) that the study medicine called "liposomal bupivacaine" has on subjects that are undergoing a sternotomy. Liposomal bupivacaine solution, is a drug that the doctor will inject before they make the cut through patient's breastbone (sternotomy). Normally pain medicine like this is given right before the surgeon closes up the patient's breastbone, at the end of the surgery. For this study, they want to see if giving the medicine before they make the cut into the patient's breastbone helps their pain. They also want to find out if patients feel less pain after surgery with the study drug than they do with saline and possibly decrease the need for pain medicine. Subjects will be in the study for about 72 hours or until they are discharged from the hospital.

Condition or disease Intervention/treatment Phase
Cardiovascular Surgery Pain, Postoperative Block Drug: Liposomal bupivacaine Drug: Normal Saline Flush, 0.9% Injectable Solution_#1 Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The surgeon, coordinator and anesthesiologist on the case are blinded to the block drug. A 2nd (unblinded) anesthesiologist performs the block on the patient.
Primary Purpose: Other
Official Title: Regional Blockade of the Sternum With Liposomal Bupivacaine Prior to Incision Decreases Opioid Use in Patients Undergoing Cardiac Surgery (Sternal Block)
Actual Study Start Date : February 6, 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Liposomal Bupivacaine Block
Liposomal Bupivacaine (1.3%) solution (20 mL dose). This solution has demonstrated increased efficacy in prolonged analgesia following injection. This solution will be injected as an ultrasound-guided subpectoral interfacial plane block.
Drug: Liposomal bupivacaine
Sternal Block during Coronary Artery Bypass Graft Surgery and/or surgical aortic valve replacement through mini- or full sternotomy

Placebo Comparator: Saline Block
Normal saline (0.9%) will be used as the control solution for patients not receiving the liposomal bupivacaine solution. Injection procedure of this solution will be identical to that of the liposomal bupivacaine solution.
Drug: Normal Saline Flush, 0.9% Injectable Solution_#1
Sternal Block during Coronary Artery Bypass Graft Surgery and/or surgical aortic valve replacement through mini- or full sternotomy

Primary Outcome Measures :
  1. Postoperative opioid measured in Milligram Morphine Equivalent (MME) [ Time Frame: Up to 72 hours post-op ]
    The amount of opioid medications used will be recorded during the routine postoperative course.

  2. Postoperative Pain Scores measured with standard pain scores (0-10) [ Time Frame: Up to 72 hours post-op ]
    Range 0 (No pain) to 10 (Worst pain)

Secondary Outcome Measures :
  1. Intraoperative opioid usage measured in Milligram Morphine Equivalent (MME) [ Time Frame: During surgery ]

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:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age greater than 18 years
  2. Undergoing a surgical procedure through mini- or full sternotomy.

Exclusion Criteria:

  1. Clinical instability
  2. Allergic to liposomal bupivacaine solution or any of its ingredients
  3. Maximum-allowed dosage of local analgesia will be exceeded by the injection amount of liposomal bupivacaine used in this study (<50 kg).
  4. BMI >45
  5. Pregnant or nursing
  6. Chronic home opioid usage
  7. Left Ventricular Ejection Fraction (LVEF) < 30%
  8. Low cardiac output requiring mechanical or inotropic support
  9. End-stage renal disease
  10. Cirrhosis

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 identifier (NCT number): NCT04333095

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United States, Texas
Baylor Scott & White Heart Hospital - Plano Recruiting
Plano, Texas, United States, 75093
Contact: Sarah M Hale, BA    469-814-4720   
Principal Investigator: Katherine B Harrington, MD         
Sponsors and Collaborators
Baylor Research Institute
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Responsible Party: Baylor Research Institute Identifier: NCT04333095    
Other Study ID Numbers: 019-296
First Posted: April 3, 2020    Key Record Dates
Last Update Posted: January 27, 2021
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: At this point, we do not plan to shared IPD but will share cumulative results in an abstract and manuscript.

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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
Neurologic Manifestations
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents