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The purpose of this study is to determine if ultrasound-guided bilateral pectointercostal fascial plane blocks with bilateral rectus sheath blocks block decrease pain scores, decrease opioid consumption, improve respiratory function, and improve quality of recovery in patients recovering from elective cardiac surgery involving primary median sternotomy and mediastinal chest tubes in comparison to pectointercostal fascial plane blocks alone.
This is a single center, prospective, randomized, controlled, double-blinded study. We anticipate recruitment of 62 subjects, with 25-30 in each group.
Primary Outcomes:
Pain scores on a 0-10 visual analog scale (VAS) at rest and with deep breathing at 1, 3, 6, 12, 18, and 24 hours post-extubation between subjects receiving PIFB + RSB versus subjects receiving only PIFB.
Total cumulative opioid consumption at 24 and 48 hours post-operatively.
Secondary Outcomes:
Preoperative Management :
Subjects will be randomized on the morning of surgery to receive bilateral PIFB and bilateral RSB with local anesthetic versus bilateral PIFB with local anesthetic and bilateral RSB with saline (placebo).
Intraoperative Management All subjects will receive the standard of care anesthetic regimen for their cardiac surgery.
Postoperative Management Each PIFB will be performed with 15 mL of 0.25% bupivacaine with 5 mcg/ml of epinephrine, and bilateral RSB will be performed with an additional 20 mL of 0.25% bupivacaine with 5 mcg/ml of epinephrine (10mL on each side).
Postoperative Evaluation:
Evaluation of acute postoperative pain intensity using a 0-10 visual analog scale (VAS) will be undertaken at the following time points, both at rest and with deep breathing:
• 1, 3, 6, 12, 18, and 24 hours post-extubation Incentive spirometry will be assessed at 1, 3, 12, and 24 hours post-extubation, with three measures taken at each time point in order to compare postoperative performance with baseline spirometry.
Review of the medical chart will be made post-operatively to gather other data, including total intraoperative oral morphine equivalent consumption, cumulative opioid consumption at 24 and 48 hours, time from ICU arrival to tracheal extubation, hospital and ICU length of stay, and QoR-15 (Quality of Recovery) score administered 24 hours after extubation (with margin of error of 18-30 hours to avoid waking patients in the middle of the night) . Occurrences of any adverse events reported by the subject or medical team will also be collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rectus sheath block block with PIFB (experimental arm) | Experimental | PIFB with local anesthetic with RSB with local anesthetic (bupivacaine) |
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| Rectus sheath block with PIFB (placebo arm) | Placebo Comparator | PIFB with local anesthetic with RSB placebo (saline) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rectus sheath block with bupivacaine | Drug | Rectus sheath block with local anesthetic versus sham block with saline |
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| Measure | Description | Time Frame |
|---|---|---|
| Pain Scores at Rest Within the First 24 Hours After Extubation | Measured by area under the curve (AUC) for pain scores gathered at 1, 3, 6, 12, 18, and 24 hours after extubation. To calculate the Area Under the Curve (AUC) for pain scores, pain intensity is plotted against time and the trapezoidal rule is used to approximate the area under the resulting curve. This AUC value represents the overall pain experience, considering both pain intensity and duration. Scale 0-240, with higher indicating a worse outcome. Units: Numeric rating score * hours. | 24 hours after extubation |
| Pain Scores With Deep Breathing Within the First 24 Hours After Extubation | Measured by area under the curve (AUC) for pain scores gathered at 1, 3, 6, 12, 18, and 24 hours after extubation. To calculate the Area Under the Curve (AUC) for pain scores, pain intensity is plotted against time and the trapezoidal rule is used to approximate the area under the resulting curve. This AUC value represents the overall pain experience, considering both pain intensity and duration. Scale 0-240, with higher indicating a worse outcome. Units: Numeric rating score * hours. | 24 hours after extubation |
| Total Cumulative Opioid Consumption | Total cumulative opioid consumption at 24 hours | 24 hours post-operatively |
| Total Cumulative Opioid Consumption | Total cumulative opioid consumption at 48 hours | 48 hours post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Time From ICU Arrival to Liberation From Mechanical Ventilation | Time from ICU arrival as measured by "anesthesia stop" to liberation from mechanical ventilation (extubation). | ICU arrival until extubation |
| Vital Capacity Change From Baseline on Incentive Spirometry |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne Castro | Medical College of Wisconsin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Rectus Sheath Block With PIFB (Experimental Arm) | PIFB with local anesthetic with RSB with local anesthetic (bupivacaine) Rectus sheath block with bupivacaine: Rectus sheath block with local anesthetic versus sham block with saline |
| FG001 | Rectus Sheath Block With PIFB (Placebo Arm) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Sep 30, 2024 |
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Vital capacity change from baseline on incentive spirometry, measured as a percentage. An incentive spirometer was used to gather vital capacity (measured in mL). |
| 1 hour post-extubation |
| Vital Capacity Change From Baseline on Incentive Spirometry | Vital capacity change from baseline on incentive spirometry, measured as a percentage. An incentive spirometer was used to gather vital capacity (measured in mL). | 3 hours post-extubation |
| Vital Capacity Change From Baseline on Incentive Spirometry | Vital capacity change from baseline on incentive spirometry, measured as a percentage. An incentive spirometer was used to gather vital capacity (measured in mL). | 12 hours post-extubation |
| Vital Capacity Change From Baseline on Incentive Spirometry | Vital capacity change from baseline on incentive spirometry, measured as a percentage. An incentive spirometer was used to gather vital capacity (measured in mL). | 24 hours post-extubation |
| QoR-15 (Quality of Recovery) Score | QoR-15 (Quality of Recovery) score is a 15 question survey asking patients about various aspects of their quality of recovery, including pain control, nausea, anxiety, depression, ability to eat, etc. The scale is 0-150, with higher scores indicating a better outcome. | 24 hours after extubation |
| ICU Length of Stay | ICU Length of Stay in hours, as measured by anesthesia stop until transfer out of the ICU. | Time from anesthesia stop to transfer out of ICU, typically 24 hours |
| Hospital Length of Stay | Hospital Length of Stay in hours, as measured by anesthesia stop until discharge from the hospital. | Time from anesthesia stop to hospital discharge, typically one week |
PIFB with local anesthetic with RSB placebo (saline) Rectus sheath block with bupivacaine: Rectus sheath block with local anesthetic versus sham block with saline |
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| ID | Title | Description |
|---|---|---|
| BG000 | Rectus Sheath Block With Pectointercostal Fascial Plane Block (Experimental Arm) | PIFB with local anesthetic with RSB with local anesthetic (bupivacaine) Rectus sheath block with bupivacaine: Rectus sheath block with local anesthetic versus sham block with saline |
| BG001 | Rectus Sheath Block With Pectointercostal Fascial Plane Block (Placebo Arm) | PIFB with local anesthetic with RSB placebo (saline) Rectus sheath block with bupivacaine: Rectus sheath block with local anesthetic versus sham block with saline |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Mass Index | Mean | Standard Deviation | kg/m2 |
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| Hypertension diagnosis | Count of Participants | Participants |
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| Diabetes diagnosis | Count of Participants | Participants |
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| Coronary artery disease diagnosis | Count of Participants | Participants |
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| Peripheral Vascular Disease diagnosis | Count of Participants | Participants |
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| Neuropathy diagnosis | Count of Participants | Participants |
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| Anxiety diagnosis | Count of Participants | Participants |
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| Depression diagnosis | Count of Participants | Participants |
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| History of Cerebral Vascular Accident | Count of Participants | Participants |
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| Chronic Kidney Disease/End Stage Renal Disease diagnosis | Count of Participants | Participants |
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| Chronic Obstructive Pulmonary Disease diagnosis | Count of Participants | Participants |
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| Coronary Artery Bypass Graft Surgery | Count of Participants | Participants |
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| Coronary Artery Bypass Graft with single valve | Count of Participants | Participants |
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| Single valve case | Count of Participants | Participants |
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| Aortic crossclamp time (hours) | The block occurred at the end of surgery, so in no way should have affected intraoperative surgical characteristics. The characteristics of surgery are therefore a baseline measure, not an outcome measure. | Mean | Standard Deviation | hours |
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| Cardiopulmonary bypass time (hours) | The block occurred at the end of surgery, so in no way should have affected intraoperative surgical characteristics. The characteristics of surgery are therefore a baseline measure, not an outcome measure. | Mean | Standard Deviation | hours |
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| Total surgical time (hours) | The block occurred at the end of surgery, so in no way should have affected intraoperative surgical characteristics. The characteristics of surgery are therefore a baseline measure, not an outcome measure. | Mean | Standard Deviation | hours |
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| Intraoperative oral morphine equivalents (mg) | The block occurred at the end of surgery, so in no way should have affected intraoperative surgical characteristics. The characteristics of surgery are therefore a baseline measure, not an outcome measure. | Mean | Standard Deviation | mg |
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| 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 | Pain Scores at Rest Within the First 24 Hours After Extubation | Measured by area under the curve (AUC) for pain scores gathered at 1, 3, 6, 12, 18, and 24 hours after extubation. To calculate the Area Under the Curve (AUC) for pain scores, pain intensity is plotted against time and the trapezoidal rule is used to approximate the area under the resulting curve. This AUC value represents the overall pain experience, considering both pain intensity and duration. Scale 0-240, with higher indicating a worse outcome. Units: Numeric rating score * hours. | Posted | Median | Inter-Quartile Range | Numeric rating score * hours. | 24 hours after extubation |
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| Primary | Pain Scores With Deep Breathing Within the First 24 Hours After Extubation | Measured by area under the curve (AUC) for pain scores gathered at 1, 3, 6, 12, 18, and 24 hours after extubation. To calculate the Area Under the Curve (AUC) for pain scores, pain intensity is plotted against time and the trapezoidal rule is used to approximate the area under the resulting curve. This AUC value represents the overall pain experience, considering both pain intensity and duration. Scale 0-240, with higher indicating a worse outcome. Units: Numeric rating score * hours. | Posted | Median | Inter-Quartile Range | Numeric rating score * hours. | 24 hours after extubation |
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| Primary | Total Cumulative Opioid Consumption | Total cumulative opioid consumption at 24 hours | Posted | Median | Inter-Quartile Range | Oral morphine equivalents (mg) | 24 hours post-operatively |
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| Primary | Total Cumulative Opioid Consumption | Total cumulative opioid consumption at 48 hours | Posted | Median | Inter-Quartile Range | Oral morphine equivalents (mg) | 48 hours post-operatively |
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| Secondary | Time From ICU Arrival to Liberation From Mechanical Ventilation | Time from ICU arrival as measured by "anesthesia stop" to liberation from mechanical ventilation (extubation). | Posted | Median | Inter-Quartile Range | hours | ICU arrival until extubation |
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| Secondary | Vital Capacity Change From Baseline on Incentive Spirometry | Vital capacity change from baseline on incentive spirometry, measured as a percentage. An incentive spirometer was used to gather vital capacity (measured in mL). | 7 total patients did not have IS completed at 1 hour by ICU nursing due to either need for bipap/unknown reason. | Posted | Median | Inter-Quartile Range | Percent of baseline IS | 1 hour post-extubation |
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| Secondary | Vital Capacity Change From Baseline on Incentive Spirometry | Vital capacity change from baseline on incentive spirometry, measured as a percentage. An incentive spirometer was used to gather vital capacity (measured in mL). | Posted | Median | Inter-Quartile Range | Percent of baseline IS | 3 hours post-extubation |
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| Secondary | Vital Capacity Change From Baseline on Incentive Spirometry | Vital capacity change from baseline on incentive spirometry, measured as a percentage. An incentive spirometer was used to gather vital capacity (measured in mL). | 3 total patients did not have IS completed at 12 hours by ICU nursing for unknown reasons | Posted | Median | Inter-Quartile Range | Percent of baseline IS | 12 hours post-extubation |
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| Secondary | Vital Capacity Change From Baseline on Incentive Spirometry | Vital capacity change from baseline on incentive spirometry, measured as a percentage. An incentive spirometer was used to gather vital capacity (measured in mL). | 7 total patients did not have IS completed at 24 hours by ICU nursing due to unknown reasons. | Posted | Median | Inter-Quartile Range | Percent of baseline IS | 24 hours post-extubation |
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| Secondary | QoR-15 (Quality of Recovery) Score | QoR-15 (Quality of Recovery) score is a 15 question survey asking patients about various aspects of their quality of recovery, including pain control, nausea, anxiety, depression, ability to eat, etc. The scale is 0-150, with higher scores indicating a better outcome. | Posted | Median | Inter-Quartile Range | score on a scale | 24 hours after extubation |
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| Secondary | ICU Length of Stay | ICU Length of Stay in hours, as measured by anesthesia stop until transfer out of the ICU. | Posted | Median | Inter-Quartile Range | Hours | Time from anesthesia stop to transfer out of ICU, typically 24 hours |
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| Secondary | Hospital Length of Stay | Hospital Length of Stay in hours, as measured by anesthesia stop until discharge from the hospital. | Posted | Median | Inter-Quartile Range | Hours | Time from anesthesia stop to hospital discharge, typically one week |
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Each patient had adverse event data recorded through study completion and surgical follow-up, which was an average of one month.
Each patient was seen POD 1 or 2 by the regional service to assess for complications. Also, study team members reviewed each patient's hospital course until the time of discharge to assess for complications, and OnCore was used to enroll patients in the study, which flagged the study team if the patient was seen/admitted (if documented in EPIC) post-discharge for any potential complications that could be reviewed. Each patient had adverse event data recorded through study completion.
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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 | Rectus Sheath Block With PIFB (Experimental Arm) | PIFB with local anesthetic with RSB with local anesthetic (bupivacaine) Rectus sheath block with bupivacaine: Rectus sheath block with local anesthetic versus sham block with saline | 0 | 30 | 0 | 30 | 0 | 30 |
| EG001 | Rectus Sheath Block With PIFB (Placebo Arm) | PIFB with local anesthetic with RSB placebo (saline) Rectus sheath block with bupivacaine: Rectus sheath block with local anesthetic versus sham block with saline | 1 | 32 | 1 | 32 | 0 | 32 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute right heart failure | Cardiac disorders | Systematic Assessment | A patient developed right heart failure postoperatively, requiring right ventricular assist device placement, which required removal from the study. The patient's clinical team and study independent monitor verified that this was not block-related. |
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| Cardiac arrest | Cardiac disorders | Systematic Assessment | One patient expired within hours following surgery due to cardiac arrest that was determined to be the result of major surgical bleeding (cardiac). The patient's clinical team and study independent monitor verified that this was not block-related. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anne L. Castro | Medical College of Wisconsin | (414) 805-8700 | anncastro@mcw.edu |
| Jun 24, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 31, 2023 | Jun 24, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D010149 | Pain, Postoperative |
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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