Parasternal Nerve Block in Cardiac Patients
Primary Purpose
Coronary Artery Disease, Pain, Postoperative
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Exparel
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Pain management, Anesthetic, local, Nerve blockade, Coronary Artery Bypass Surgery, Analgesics, opioid, Postoperative complications, Bupivacaine
Eligibility Criteria
Inclusion Criteria:
- ≥ 18 years old
- non-emergent coronary artery bypass grafting surgery (on and off pump)
- median sternotomy
Exclusion Criteria:
- Concomitant cardiac procedures (e.g. aortic valve repair/replacement, mitral valve repair/replacement, aortic root replacements).
- Redo sternotomy.
- < 50 kg (Exparel® is currently only approved in patients > 50 kg).
- Pregnant or nursing
- History of alcohol, narcotic or illicit drug abuse
- Participation in another study evaluating investigational medications within the past 30 days
- Taking narcotic analgesics within 3 days pre-operatively or perioperative stress-dose steroids.
- Chronic non-cardiac pain (e.g. lower back pain, fibromyalgia) requiring narcotic analgesics.
- Pre-operative mild liver insufficiency as defined by liver function tests [(i.e. alanine aminotransferase (ALT), aspartate aminotransferase (AST)] ≥ 1.5 times the upper limit of normal (ULN: ALT: 0-35 U/L, AST: 0-35 U/L, Alk Phos 35-105 U/L, Total bilirubin: 0-1.2 mg/dL)
- Pre-operative mild renal insufficiency (Cr ≥ 1.5 mg/dL)
- Allergy to amide-type anesthetics
- Recurrent ventricular arrhythmias, low cardiac output requiring inotrope and/or intra-aortic balloon pump support, left ventricular ejection fraction < 30% at time of pre-operative screening/evaluation.
- Unable to provide informed consent or unable to understand how to use pain rating scales.
- Inability to understand or operate the patient-controlled analgesia (PCA) machine.
Sites / Locations
- University of Rochester Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Exparel
Placebo
Arm Description
266 mg Exparel, single-dose injection.
0.9% Normal saline, single-dose injection.
Outcomes
Primary Outcome Measures
Median Cumulative Morphine Equivalent
The cumulative opioid requirement is reported as morphine equivalent. The total amount of narcotics required by the subjects in the Exparel group and placebo group were measured at 1,2,4,8,12,24,36,48,60, and 72 hours post-injection of Exparel or 0.9% normal saline. The amounts were analyzed and are reported as morphine equivalents.
Median Pain Levels
The pain scores of the subjects in the Exparel group and placebo group were measured at 1,2,4,8,12,24,36,48,60, and 72 hours post-injection of Exparel or 0.9% normal saline. The pain scores were reported on a scale of 0 - 10. 0 being no pain. 10 being the worst pain.
Secondary Outcome Measures
Time to Extubation (Hours)
Time to remove endotracheal tube following surgery.
ICU Length of Stay (Hours)
Duration of time spent in the intensive care unit postoperatively.
Time to First Bowel Movement (Days)
Time to first bowel movement following surgery.
Hospital Length of Stay (Days)
Duration of time spent in the hospital following surgery.
Time to Return to Work or Daily Activities
Time to return to work or daily activities following surgery will be assessed at postoperative clinic follow up or during a follow up telephone interview.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01826851
Brief Title
Parasternal Nerve Block in Cardiac Patients
Official Title
Parasternal Intercostal Nerve Block in Post-Cardiac Surgery Patients: A Randomized, Controlled Trial of Extended-release Liposomal Bupivacaine (Exparel) Versus Placebo
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Peter A Knight
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Exparel is a new local analgesic (numbing medication) that is intended to be longer acting than currently available local analgesics. The purpose of this study is to determine whether use of Exparel to numb the nerves along the breastbone after open heart surgery, will decrease pain and pain medication use after surgery.
Detailed Description
This is a Phase 2, single-institution, randomized, double-blind, parallel-group, placebo-controlled trial of patients undergoing a median sternotomy for primary cardiopulmonary bypass grafting (CABG) surgery.
78 subjects (39 per treatment arm) will be randomized in a 1:1 ratio to receive a single-dose, parasternal nerve block with either 266 mg Exparel or placebo (0.9% normal saline solution). The nerve blocks will be performed under direct visualization at the end of surgery, just prior to sternal closure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Pain, Postoperative
Keywords
Pain management, Anesthetic, local, Nerve blockade, Coronary Artery Bypass Surgery, Analgesics, opioid, Postoperative complications, Bupivacaine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
79 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exparel
Arm Type
Experimental
Arm Description
266 mg Exparel, single-dose injection.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
0.9% Normal saline, single-dose injection.
Intervention Type
Drug
Intervention Name(s)
Exparel
Other Intervention Name(s)
SKY0402, Bupivacaine liposome extended-release injectable suspension
Intervention Description
Patients in this group will receive 266 mg Exparel diluted with 0.9% normal saline to a total volume of 50 mL and administered via parasternal intercostal nerve block prior to sternal closure.
Post-operatively, patients will receive IV fentanyl as needed in the ICU while still intubated. A fentanyl PCA pump will be set up post-extubation as soon as possible and prior to the patient leaving the ICU.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Preservative-free normal saline
Intervention Description
Patients in this group will receive 50 mL of 0.9% normal saline as a parasternal intercostal nerve block prior to sternal closure.
Post-surgical pain management will be the same as for the Exparel group.
Primary Outcome Measure Information:
Title
Median Cumulative Morphine Equivalent
Description
The cumulative opioid requirement is reported as morphine equivalent. The total amount of narcotics required by the subjects in the Exparel group and placebo group were measured at 1,2,4,8,12,24,36,48,60, and 72 hours post-injection of Exparel or 0.9% normal saline. The amounts were analyzed and are reported as morphine equivalents.
Time Frame
Outcome was measured at 1,2,4,8,12,24,36,48,60, and 72 hours post intercostal nerve block.
Title
Median Pain Levels
Description
The pain scores of the subjects in the Exparel group and placebo group were measured at 1,2,4,8,12,24,36,48,60, and 72 hours post-injection of Exparel or 0.9% normal saline. The pain scores were reported on a scale of 0 - 10. 0 being no pain. 10 being the worst pain.
Time Frame
Outcome was measured at 1,2,4,8,12,24,36,48,60, and 72 hours post intercostal nerve block.
Secondary Outcome Measure Information:
Title
Time to Extubation (Hours)
Description
Time to remove endotracheal tube following surgery.
Time Frame
77 hours
Title
ICU Length of Stay (Hours)
Description
Duration of time spent in the intensive care unit postoperatively.
Time Frame
135 hours
Title
Time to First Bowel Movement (Days)
Description
Time to first bowel movement following surgery.
Time Frame
35 days
Title
Hospital Length of Stay (Days)
Description
Duration of time spent in the hospital following surgery.
Time Frame
25 days
Title
Time to Return to Work or Daily Activities
Description
Time to return to work or daily activities following surgery will be assessed at postoperative clinic follow up or during a follow up telephone interview.
Time Frame
36 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
≥ 18 years old
non-emergent coronary artery bypass grafting surgery (on and off pump)
median sternotomy
Exclusion Criteria:
Concomitant cardiac procedures (e.g. aortic valve repair/replacement, mitral valve repair/replacement, aortic root replacements).
Redo sternotomy.
< 50 kg (Exparel® is currently only approved in patients > 50 kg).
Pregnant or nursing
History of alcohol, narcotic or illicit drug abuse
Participation in another study evaluating investigational medications within the past 30 days
Taking narcotic analgesics within 3 days pre-operatively or perioperative stress-dose steroids.
Chronic non-cardiac pain (e.g. lower back pain, fibromyalgia) requiring narcotic analgesics.
Pre-operative mild liver insufficiency as defined by liver function tests [(i.e. alanine aminotransferase (ALT), aspartate aminotransferase (AST)] ≥ 1.5 times the upper limit of normal (ULN: ALT: 0-35 U/L, AST: 0-35 U/L, Alk Phos 35-105 U/L, Total bilirubin: 0-1.2 mg/dL)
Pre-operative mild renal insufficiency (Cr ≥ 1.5 mg/dL)
Allergy to amide-type anesthetics
Recurrent ventricular arrhythmias, low cardiac output requiring inotrope and/or intra-aortic balloon pump support, left ventricular ejection fraction < 30% at time of pre-operative screening/evaluation.
Unable to provide informed consent or unable to understand how to use pain rating scales.
Inability to understand or operate the patient-controlled analgesia (PCA) machine.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter A Knight, MD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
30170012
Citation
Lee CY, Robinson DA, Johnson CA Jr, Zhang Y, Wong J, Joshi DJ, Wu TT, Knight PA. A Randomized Controlled Trial of Liposomal Bupivacaine Parasternal Intercostal Block for Sternotomy. Ann Thorac Surg. 2019 Jan;107(1):128-134. doi: 10.1016/j.athoracsur.2018.06.081. Epub 2018 Aug 28.
Results Reference
derived
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