A Phase 3 interventional study of Bupivacaine Group and Placebo in Coronary Artery Disease and Sternal Pain, sponsored by Beth Israel Deaconess Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-03.
Sponsored by Beth Israel Deaconess Medical Center · Phase 3, Interventional, and Treatment
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.
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
This study's enrollment of 80 is below the median of 124 across 3,006 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Beth Israel Deaconess Medical Center is the lead sponsor of 568 studies on the registry; 80 are open to participants now.
Of its 76 completed or terminated interventional studies of FDA-regulated products, 62 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
20 cc of 0.25% bupivacaine on each side of the sternum at two time points after surgery and POD1
Drug: Bupivacaine Group
20 cc of saline on each side of the sternum at two time points after surgery and POD1
Other: Placebo
20cc bupivacaine hydrochloride will be administered on each side at two different time points (immediately post operatively and on day 1).
20cc placebo (0.9% NaCl) will be administered on each side at two different time points (immediately post operatively and on day 1).
Opioid Consumption
Total opioid consumption in the first 48 hours post-operatively, measured as milligram morphine equivalents (MME).
Time frame: 48 hours
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
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
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
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
| Milestone | Interventional Bupivacaine | Interventional Placebo |
|---|---|---|
| Started | 40 | 40 |
| Completed | 40 | 40 |
| Not completed | 0 | 0 |
Total opioid consumption in the first 48 hours post-operatively, measured as milligram morphine equivalents (MME).
| Milligram Morphine Equivalents (MME) | Interventional Bupivacaine | Interventional Placebo |
|---|---|---|
| Opioid Consumption | 40.8 ± 22.4 | 49.1 ± 26.9 |
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.
| score on a scale | Interventional Bupivacaine | Interventional Placebo |
|---|---|---|
| Pain Scores | 4.8 ± 2.7 | 5.1 ± 2.6 |
Total duration of stay in ICU for the index admission
| days | Interventional Bupivacaine | Interventional Placebo |
|---|---|---|
| ICU Length of Stay | 1.2 (1.0 to 2.8) | 1.7 (1.0 to 3.2) |
Their stay in the hospital for the index admission
| days | Interventional Bupivacaine | Interventional Placebo |
|---|---|---|
| Hospital Length of Stay | 8 (7 to 11) | 7.5 (6 to 10) |
This includes infection, hematoma, local anesthetic systemic toxicity directly related to the block or the drug used in the block
| Participants | Interventional Bupivacaine | Interventional Placebo |
|---|---|---|
| Number of Participants With Complications | 0 | 0 |
Collected over All adverse events will be assessed daily during the hospital stay for a maximum of 4 postoperative days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Interventional Bupivacaine | 0/40 (0%) | 0/40 (0%) | 0/40 (0%) |
| Interventional Placebo | 1/40 (2.5%) | 1/40 (2.5%) | 0/40 (0%) |
| Event | Interventional Bupivacaine | Interventional Placebo |
|---|---|---|
| Abdominal SepsisInfections and infestations | 0/40 | 1/40 |
| Age, Continuous(years) | Interventional Bupivacaine | Interventional Placebo | Total |
|---|---|---|---|
| Mean | 65.78 ± 8.73 | 65.70 ± 9.86 | 65.73 ± 9.25 |
| Sex: Female, Male(Participants) | Interventional Bupivacaine | Interventional Placebo | Total |
|---|---|---|---|
| Female | 13 | 6 | 19 |
| Male | 27 | 34 | 61 |
| Ethnicity (NIH/OMB)(Participants) | Interventional Bupivacaine | Interventional Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 1 |
| Not Hispanic or Latino | 31 | 27 | 58 |
| Unknown or Not Reported | 8 | 13 | 21 |
| Race (NIH/OMB)(Participants) | Interventional Bupivacaine | Interventional Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 33 | 32 | 65 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 6 | 8 | 14 |
| Region of Enrollment(participants) | Interventional Bupivacaine | Interventional Placebo | Total |
|---|---|---|---|
| United States | 40 | 40 | 80 |
| Weight(Kg) | Interventional Bupivacaine | Interventional Placebo | Total |
|---|---|---|---|
| Mean | 86.53 ± 18.44 | 85.55 ± 15.10 | 86.04 ± 16.75 |
| Height(cm) | Interventional Bupivacaine | Interventional Placebo | Total |
|---|---|---|---|
| Mean | 173.73 ± 12.08 | 172.02 ± 9.96 | 172.88 ± 11.03 |
| Body Mass Index (BMI)(Kg/m^2) | Interventional Bupivacaine | Interventional Placebo | Total |
|---|---|---|---|
| Mean | 28.57 ± 5.10 | 28.92 ± 4.84 | 28.74 ± 4.94 |
3 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jun 2018 to primary completion in Nov 2019, 17 months.
Results were first posted in Aug 2020, 8 months after primary completion.
Of 61 phase 3 interventional studies under Coronary Artery Disease, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 58. This study's 17 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Bupivacaine
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