Coronary Artery Disease, Sternal Pain
Conditions
Keywords
Cardiopulmonary Bypass, Cardiac Surgery, Sternotomy
Brief summary
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.
Detailed description
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.
Interventions
20cc bupivacaine hydrochloride will be administered on each side at two different time points (immediately post operatively and on day 1).
OTHERPlacebo
20cc placebo (0.9% NaCl) will be administered on each side at two different time points (immediately post operatively and on day 1).
Sponsors
Beth Israel Deaconess Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients 18 years of age or older * Undergoing cardiac surgery with sternotomy, limited to CABG, CABG+valve surgeries and isolated valve surgeries.
Exclusion criteria
* Current participation in another interventional study * Preoperative LVEF \< 30% * Use of mechanical circulatory support * Emergent procedures * Aortic surgeries, transplants ventricular assist device insertions, bentall, or grafts * Minimally invasive cardiac procedures or those with thoracotomy approach * Patients receiving other modalities of regional anesthesia like intrathecal morphine * Chronic opioid use for chronic pain conditions with tolerance (total daily dose of an opioid at or more than 30 mg morphine equivalent for more than one month within the past year) * Current use of TCA, gabapentin, or pregabalin * Hypersensitivity to bupivacaine * Women who are pregnant or breastfeeding * Non English speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Consumption | 48 hours | Total opioid consumption in the first 48 hours post-operatively, measured as milligram morphine equivalents (MME). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Scores | At 6-8 hourly intervals every day until discharge or 4 days | 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. |
| ICU Length of Stay | Time of ICU admission until time of discharge to hospital floor; through the hospital stay, an average of 5 days | Total duration of stay in ICU for the index admission |
| Hospital Length of Stay | Measured in days admitted in the hospital, an average of 5 days | Their stay in the hospital for the index admission |
| Number of Participants With Complications | 7 days post-op on an average | This includes infection, hematoma, local anesthetic systemic toxicity directly related to the block or the drug used in the block |
Countries
United States
Participant flow
Pre-assignment details
80 Participants signed consent and none of the participants was withdrawn prior to randomization.
Participants by arm
| Arm | Count |
|---|---|
| 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). | 40 |
| 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). | 40 |
| Total | 80 |
Baseline characteristics
| Characteristic | Interventional Bupivacaine | Interventional Placebo | Total |
|---|---|---|---|
| Age, Continuous | 65.78 years STANDARD_DEVIATION 8.73 | 65.70 years STANDARD_DEVIATION 9.86 | 65.73 years STANDARD_DEVIATION 9.25 |
| Body Mass Index (BMI) | 28.57 Kg/m^2 STANDARD_DEVIATION 5.1 | 28.92 Kg/m^2 STANDARD_DEVIATION 4.84 | 28.74 Kg/m^2 STANDARD_DEVIATION 4.94 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 31 Participants | 27 Participants | 58 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 8 Participants | 13 Participants | 21 Participants |
| Height | 173.73 cm STANDARD_DEVIATION 12.08 | 172.02 cm STANDARD_DEVIATION 9.96 | 172.88 cm STANDARD_DEVIATION 11.03 |
| Past surgical history Cardiac surgery | 2 participants | 3 participants | 5 participants |
| Past surgical history Coronary artery stenting | 9 participants | 6 participants | 15 participants |
| Past surgical history None | 25 participants | 23 participants | 48 participants |
| Past surgical history Open abdominal surgery | 5 participants | 5 participants | 10 participants |
| Past surgical history Vascular surgery | 0 participants | 4 participants | 4 participants |
| Preoperative comorbidities Acquired immunodeficiency syndrome (AIDS) | 1 participants | 0 participants | 1 participants |
| Preoperative comorbidities Arrhythmia | 6 participants | 7 participants | 13 participants |
| Preoperative comorbidities Chronic obstructive pulmonary disease(COPD)/Asthma | 6 participants | 3 participants | 9 participants |
| Preoperative comorbidities Chronic pain | 8 participants | 6 participants | 14 participants |
| Preoperative comorbidities Coagulopathy | 0 participants | 0 participants | 0 participants |
| Preoperative comorbidities Congestive heart failure | 4 participants | 4 participants | 8 participants |
| Preoperative comorbidities Connective tissue disease | 0 participants | 0 participants | 0 participants |
| Preoperative comorbidities Diabetes with end organ damage | 4 participants | 5 participants | 9 participants |
| Preoperative comorbidities Diabetes without complications | 7 participants | 8 participants | 15 participants |
| Preoperative comorbidities Hemiplegia | 0 participants | 0 participants | 0 participants |
| Preoperative comorbidities Hypercoagulability | 1 participants | 1 participants | 2 participants |
| Preoperative comorbidities Hyperlipidemia | 29 participants | 23 participants | 52 participants |
| Preoperative comorbidities Hypertension | 31 participants | 27 participants | 58 participants |
| Preoperative comorbidities Leukemia | 0 participants | 0 participants | 0 participants |
| Preoperative comorbidities Lymphoma or multiple myeloma | 0 participants | 0 participants | 0 participants |
| Preoperative comorbidities Mild Liver disease | 0 participants | 0 participants | 0 participants |
| Preoperative comorbidities Moderate or severe liver disease | 1 participants | 0 participants | 1 participants |
| Preoperative comorbidities Moderate or severe renal disease | 5 participants | 6 participants | 11 participants |
| Preoperative comorbidities None | 0 participants | 5 participants | 5 participants |
| Preoperative comorbidities Obesity | 2 participants | 2 participants | 4 participants |
| Preoperative comorbidities Peripheral vascular disease | 2 participants | 6 participants | 8 participants |
| Preoperative comorbidities Solid tumor (Metastatic) | 0 participants | 2 participants | 2 participants |
| Preoperative comorbidities Solid tumor (Non-metastatic) | 7 participants | 6 participants | 13 participants |
| Preoperative comorbidities Ulcer disease | 2 participants | 4 participants | 6 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 8 Participants | 14 Participants |
| Race (NIH/OMB) White | 33 Participants | 32 Participants | 65 Participants |
| Region of Enrollment United States | 40 participants | 40 participants | 80 participants |
| Sex: Female, Male Female | 13 Participants | 6 Participants | 19 Participants |
| Sex: Female, Male Male | 27 Participants | 34 Participants | 61 Participants |
| Surgical characteristics CABG surgery + additional surgery | 3 Participants | 5 Participants | 8 Participants |
| Surgical characteristics Isolated Coronary artery bypass grafting (CABG) | 22 Participants | 26 Participants | 48 Participants |
| Surgical characteristics Other | 1 Participants | 1 Participants | 2 Participants |
| Surgical characteristics Valve surgery | 14 Participants | 8 Participants | 22 Participants |
| Weight | 86.53 Kg STANDARD_DEVIATION 18.44 | 85.55 Kg STANDARD_DEVIATION 15.1 | 86.04 Kg STANDARD_DEVIATION 16.75 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 1 / 40 |
| other Total, other adverse events | 0 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 | 1 / 40 |
Outcome results
Primary
Opioid Consumption
Total opioid consumption in the first 48 hours post-operatively, measured as milligram morphine equivalents (MME).
Time frame: 48 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interventional Bupivacaine | Opioid Consumption | 40.8 Milligram Morphine Equivalents (MME) | Standard Deviation 22.4 |
| Interventional Placebo | Opioid Consumption | 49.1 Milligram Morphine Equivalents (MME) | Standard Deviation 26.9 |
Secondary
Hospital Length of Stay
Their stay in the hospital for the index admission
Time frame: Measured in days admitted in the hospital, an average of 5 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Interventional Bupivacaine | Hospital Length of Stay | 8 days |
| Interventional Placebo | Hospital Length of Stay | 7.5 days |
Secondary
ICU Length of Stay
Total duration of stay in ICU for the index admission
Time frame: Time of ICU admission until time of discharge to hospital floor; through the hospital stay, an average of 5 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Interventional Bupivacaine | ICU Length of Stay | 1.2 days |
| Interventional Placebo | ICU Length of Stay | 1.7 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
Time frame: 7 days post-op on an average
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Interventional Bupivacaine | Number of Participants With Complications | 0 Participants |
| Interventional Placebo | Number of Participants With Complications | 0 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.
Time frame: At 6-8 hourly intervals every day until discharge or 4 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interventional Bupivacaine | Pain Scores | 4.8 score on a scale | Standard Deviation 2.7 |
| Interventional Placebo | Pain Scores | 5.1 score on a scale | Standard Deviation 2.6 |