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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exparel | Experimental | 266 mg Exparel, single-dose injection. |
|
| Placebo | Placebo Comparator | 0.9% Normal saline, single-dose injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exparel | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Outcome was measured at 1,2,4,8,12,24,36,48,60, and 72 hours post intercostal nerve block. |
| 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. | Outcome was measured at 1,2,4,8,12,24,36,48,60, and 72 hours post intercostal nerve block. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Extubation (Hours) | Time to remove endotracheal tube following surgery. | 77 hours |
| ICU Length of Stay (Hours) | Duration of time spent in the intensive care unit postoperatively. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter A Knight, MD | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30170012 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Exparel | 266 mg Exparel, single-dose injection. Exparel: 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. |
| FG001 | Placebo | 0.9% Normal saline, single-dose injection. Placebo: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Exparel | 266 mg Exparel, single-dose injection. Exparel: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Inter-Quartile Range | Morphine Equivalents | Outcome was measured at 1,2,4,8,12,24,36,48,60, and 72 hours post intercostal nerve block. |
|
Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Exparel | 266 mg Exparel, single-dose injection. Exparel: 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suspected bupivacaine toxicity | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter A. Knight, MD | URochester | (585) 275-6340 | Peter_Knight@URMC.Rochester.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 15, 2018 | May 3, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D010149 | Pain, Postoperative |
| D000377 | Agnosia |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
|
| Placebo | Drug | 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. |
|
|
| 135 hours |
| Time to First Bowel Movement (Days) | Time to first bowel movement following surgery. | 35 days |
| Hospital Length of Stay (Days) | Duration of time spent in the hospital following surgery. | 25 days |
| 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. | 36 days |
| BG001 | Placebo | 0.9% Normal saline, single-dose injection. Placebo: 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| OG001 | Placebo | 0.9% Normal saline, single-dose injection. Placebo: 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 | 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. | Posted | Median | Inter-Quartile Range | units on a scale | Outcome was measured at 1,2,4,8,12,24,36,48,60, and 72 hours post intercostal nerve block. |
|
|
|
| Secondary | Time to Extubation (Hours) | Time to remove endotracheal tube following surgery. | Posted | Median | Inter-Quartile Range | Hours | 77 hours |
|
|
|
| Secondary | ICU Length of Stay (Hours) | Duration of time spent in the intensive care unit postoperatively. | Posted | Median | Inter-Quartile Range | Hours | 135 hours |
|
|
|
| Secondary | Time to First Bowel Movement (Days) | Time to first bowel movement following surgery. | Data was not collected on 3 participants in the Exparel arm and 1 participant in the Placebo arm. | Posted | Median | Inter-Quartile Range | Days | 35 days |
|
|
|
| Secondary | Hospital Length of Stay (Days) | Duration of time spent in the hospital following surgery. | Posted | Median | Inter-Quartile Range | Days | 25 days |
|
|
|
| Secondary | 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. | Data was not collected on 15 participants in the Exparel arm and 17 participant in the Placebo arm. | Posted | Mean | Standard Deviation | Days | 36 days |
|
|
|
| 0 |
| 38 |
| 4 |
| 38 |
| 38 |
| 38 |
| EG001 | Placebo | 0.9% Normal saline, single-dose injection. Placebo: 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. | 0 | 41 | 10 | 41 | 40 | 41 |
| Myocardial infarction | Cardiac disorders | Systematic Assessment |
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| Transient ischemic attack | Nervous system disorders | Systematic Assessment |
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| Cerebral vascular accident with permanent deficits | Nervous system disorders | Systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Sepsis | Infections and infestations | Systematic Assessment |
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| Mediastinitis | Infections and infestations | Systematic Assessment |
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| Sternal wound dehiscence | Surgical and medical procedures | Systematic Assessment |
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| Reoperation due to graft failure | Surgical and medical procedures | Systematic Assessment |
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| Reoperation for bleeding | Surgical and medical procedures | Systematic Assessment | Return to OR for bleeding |
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| Renal failure requiring hemodialysis | Renal and urinary disorders | Systematic Assessment |
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| Phrenic nerve Injury | Surgical and medical procedures | Systematic Assessment |
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| Readmission to ICU | General disorders | Systematic Assessment |
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| Deep venous thrombosis | Vascular disorders | Systematic Assessment |
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| Pulmonary embolism | Vascular disorders | Systematic Assessment |
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| New onset SVT or ventricular tachycardia | Cardiac disorders | Systematic Assessment |
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| Heart Failure | Cardiac disorders | Systematic Assessment |
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| Coma | Nervous system disorders | Systematic Assessment |
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| Encephalopathy | Nervous system disorders | Systematic Assessment |
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| Acute limb ischemia | Vascular disorders | Systematic Assessment |
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| Multiorgan failure | General disorders | Systematic Assessment |
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| Aortic dissection | Vascular disorders | Systematic Assessment |
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| New onset ventricular fibrillation | Cardiac disorders | Systematic Assessment |
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| Bradycardia | Cardiac disorders | Systematic Assessment |
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| Bundle Branch Block | Cardiac disorders | Systematic Assessment |
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| First Degree AV Block | Cardiac disorders | Systematic Assessment |
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| Premature Atrial Contraction | Cardiac disorders | Systematic Assessment |
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| Palpitations | Cardiac disorders | Systematic Assessment |
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| Prolonged QT Interval | Cardiac disorders | Systematic Assessment |
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| Premature Ventricular Contraction | Cardiac disorders | Systematic Assessment |
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| ST Changes | Cardiac disorders | Systematic Assessment | ST segment elevation or depression on electrocardiogram |
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| Sinus Tachycardia | Cardiac disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Anxiety | General disorders | Systematic Assessment |
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| Blurred Vision | General disorders | Systematic Assessment |
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| Chills | General disorders | Systematic Assessment |
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| Diaphoresis | General disorders | Systematic Assessment | Excessive sweating |
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| Dizziness/Light headedness | General disorders | Systematic Assessment |
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| Fever | General disorders | Systematic Assessment |
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| Itching | General disorders | Systematic Assessment |
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| Metallic Taste in Mouth | General disorders | Systematic Assessment |
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| Restlessness | General disorders | Systematic Assessment |
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| Generalized Weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Miosis | Nervous system disorders | Systematic Assessment | Pupillary constriction |
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| Parasthesias | Nervous system disorders | Systematic Assessment | Numbness |
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| Somnolence | Nervous system disorders | Systematic Assessment | Abnormal drowsiness |
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| Tinnitis | Nervous system disorders | Systematic Assessment | Ringing in ears |
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| Tremors | Nervous system disorders | Systematic Assessment |
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
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| 24 hours post injection |
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| 36 hours post injection |
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| 48 hours post injection |
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| 60 hours post injection |
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| 72 hours post injection |
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