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The purpose of this study is to determine whether administration of a pecto-intercostal fascial plane block (PIFB) with bupivacaine is a more effective therapy for postoperative analgesia after cardiac surgery as compared to patients who receive a sham block of normal saline.
The purpose of this study is to determine whether administration of a pecto-intercostal fascial plane block (PIFB) with bupivacaine is a more effective therapy for postoperative analgesia after cardiac surgery as compared to patients who receive a sham block of normal saline.
Specific Aim 1: To determine whether or not a PIFB with bupivacaine can reduce postoperative pain after cardiac surgery. This will be assessed through:
(Aim 1A) opioid consumption in the first 48 hours postoperatively (Aim 1B) patient self-reported pain scores during their hospital stay
Specific Aim 2: To estimate the effect size in order to obtain information that can be used to power future research on the use of regional modalities of analgesia for cardiac surgeries.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional Bupivacaine | Experimental | 20 cc of 0.25% bupivacaine on each side of the sternum at two time points after surgery and POD1 |
|
| Interventional Placebo | Placebo Comparator | 20 cc of saline on each side of the sternum at two time points after surgery and POD1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine Group | Drug | 20cc bupivacaine hydrochloride will be administered on each side at two different time points (immediately post operatively and on day 1). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Consumption | Total opioid consumption in the first 48 hours post-operatively, measured as milligram morphine equivalents (MME). | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Scores | Patient reported pain scores on a scale from 0-10 until discharge for the index admission. Where the minimum score is 0 and, the maximum score is 10. A score of 0 means no pain and the higher the score, the greater the pain intensity, with a score of 10 means worse imaginable pain. Pain scores recorded at 6-8 hourly intervals every day until discharge or 4 days, computed as an average pain score. |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Balachundhar Subramaniam | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
80 Participants signed consent and none of the participants was withdrawn prior to randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | Interventional Bupivacaine | 20 cc of 0.25% bupivacaine on each side of the sternum at two time points after surgery and POD1 Bupivacaine Group: 20cc bupivacaine hydrochloride will be administered on each side at two different time points (immediately post operatively and on day 1). |
| FG001 | Interventional Placebo | 20 cc of saline on each side of the sternum at two time points after surgery and POD1 Placebo: 20cc placebo (0.9% NaCl) will be administered on each side at two different time points (immediately post operatively and on day 1). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Interventional Bupivacaine | 20 cc of 0.25% bupivacaine on each side of the sternum at two time points after surgery and POD1 Bupivacaine Group: 20cc bupivacaine hydrochloride will be administered on each side at two different time points (immediately post operatively and on day 1). |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Opioid Consumption | Total opioid consumption in the first 48 hours post-operatively, measured as milligram morphine equivalents (MME). | Posted | Mean | Standard Deviation | Milligram Morphine Equivalents (MME) | 48 hours |
|
All adverse events will be assessed daily during the hospital stay for a maximum of 4 postoperative days
Anticipated and unanticipated deaths, serious adverse events, and other adverse events due to any cause, whether related or unrelated to study procedures.
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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 | Interventional Bupivacaine | 20 cc of 0.25% bupivacaine on each side of the sternum at two time points after surgery and POD1 Bupivacaine Group: 20cc bupivacaine hydrochloride will be administered on each side at two different time points (immediately post operatively and on day 1). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Sepsis | Infections and infestations | Systematic Assessment |
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This is a single-center study with restrictive inclusion may place some limitations on generalizability.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Balachundhar Subramaniam | Beth Israel Deaconess Medical Center | 6176320706 | 0706 | bsubrama@bidmc.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 28, 2019 | Jun 2, 2020 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 9, 2019 | Jun 2, 2020 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Placebo | Other | 20cc placebo (0.9% NaCl) will be administered on each side at two different time points (immediately post operatively and on day 1). |
|
| At 6-8 hourly intervals every day until discharge or 4 days |
| ICU Length of Stay | Total duration of stay in ICU for the index admission | Time of ICU admission until time of discharge to hospital floor; through the hospital stay, an average of 5 days |
| Hospital Length of Stay | Their stay in the hospital for the index admission | Measured in days admitted in the hospital, an average of 5 days |
| Number of Participants With Complications | This includes infection, hematoma, local anesthetic systemic toxicity directly related to the block or the drug used in the block | 7 days post-op on an average |
| Interventional Placebo |
20 cc of saline on each side of the sternum at two time points after surgery and POD1 Placebo: 20cc placebo (0.9% NaCl) will be administered on each side at two different time points (immediately post operatively and on day 1). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Mean | Standard Deviation | Kg |
|
| Height | Mean | Standard Deviation | cm |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | Kg/m^2 |
|
| Preoperative comorbidities | Number | participants |
|
| Surgical characteristics | Count of Participants | Participants |
|
| Past surgical history | Number | participants |
|
|
|
| Secondary | Pain Scores | Patient reported pain scores on a scale from 0-10 until discharge for the index admission. Where the minimum score is 0 and, the maximum score is 10. A score of 0 means no pain and the higher the score, the greater the pain intensity, with a score of 10 means worse imaginable pain. Pain scores recorded at 6-8 hourly intervals every day until discharge or 4 days, computed as an average pain score. | Posted | Mean | Standard Deviation | score on a scale | At 6-8 hourly intervals every day until discharge or 4 days |
|
|
|
| Secondary | ICU Length of Stay | Total duration of stay in ICU for the index admission | Posted | Median | Inter-Quartile Range | days | Time of ICU admission until time of discharge to hospital floor; through the hospital stay, an average of 5 days |
|
|
|
| Secondary | Hospital Length of Stay | Their stay in the hospital for the index admission | Posted | Median | Inter-Quartile Range | days | Measured in days admitted in the hospital, an average of 5 days |
|
|
|
| Secondary | Number of Participants With Complications | This includes infection, hematoma, local anesthetic systemic toxicity directly related to the block or the drug used in the block | Posted | Count of Participants | Participants | 7 days post-op on an average |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Interventional Placebo | 20 cc of saline on each side of the sternum at two time points after surgery and POD1 Placebo: 20cc placebo (0.9% NaCl) will be administered on each side at two different time points (immediately post operatively and on day 1). | 1 | 40 | 1 | 40 | 0 | 40 |
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |