Coronary Artery Disease, Postoperative Pain, Respiratory Failure
Conditions
Keywords
local anesthetic, regional anesthesia, quality of recovery, postoperative pain, coronary artery bypass graft
Brief summary
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.
Detailed description
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: * Intraoperative total opioid consumption * Change from baseline on incentive spirometry at 1, 3, 12, and 24 hours post-extubation * Time from ICU arrival to liberation from mechanical ventilation * QoR-15 (Quality of Recovery) score23 24 hours after extubation * Hospital and ICU length of stay 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.
Interventions
DRUGRectus sheath block with bupivacaine
Rectus sheath block with local anesthetic versus sham block with saline
Sponsors
Medical College of Wisconsin
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 85 Years
Healthy volunteers
No
Inclusion criteria
* Subjects scheduled for cardiac surgery involving primary median sternotomy and mediastinal chest tubes. * Age 18-85 years of age * BMI 18-50 kg/m2 * Weight \> 60 kg
Exclusion criteria
* Left ventricular ejection fraction (LVEF) \< 30% * Preoperative, intraoperative, or immediate post-operative placement of intra-aortic balloon pump or deployment of extra-corporeal membrane oxygenation (ECMO) * Inability to understand or speak English * Allergy to bupivacaine or other amide local anesthetic * Contraindication to peripheral nerve block (e.g. local infection, previous trauma to the block site) * Chronic opioid consumption (daily oral morphine equivalent of \>20 mg) in the past three months * Severe pulmonary or hepatic disease * Neurological deficit or disorder * Suspected or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past two years * Uncontrolled anxiety, schizophrenia, or other severe psychiatric disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Scores at Rest Within the First 24 Hours After Extubation | 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. |
| Pain Scores With Deep Breathing Within the First 24 Hours After Extubation | 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. |
| Total Cumulative Opioid Consumption | 24 hours post-operatively | Total cumulative opioid consumption at 24 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ICU Length of Stay | Time from anesthesia stop to transfer out of ICU, typically 24 hours | ICU Length of Stay in hours, as measured by anesthesia stop until transfer out of the ICU. |
| Time From ICU Arrival to Liberation From Mechanical Ventilation | ICU arrival until extubation | Time from ICU arrival as measured by anesthesia stop to liberation from mechanical ventilation (extubation). |
| Hospital Length of Stay | Time from anesthesia stop to hospital discharge, typically one week | Hospital Length of Stay in hours, as measured by anesthesia stop until discharge from the hospital. |
| Vital Capacity Change From Baseline on Incentive Spirometry | 1 hour post-extubation | Vital capacity change from baseline on incentive spirometry, measured as a percentage. An incentive spirometer was used to gather vital capacity (measured in mL). |
| QoR-15 (Quality of Recovery) Score | 24 hours after extubation | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 30 |
| 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 | 30 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Patient required postop RVAD, unrelated to block | 0 | 1 |
| Overall Study | Patient with major surgical bleeding unerlated to block | 0 | 1 |
Baseline characteristics
| Characteristic | Rectus Sheath Block With Pectointercostal Fascial Plane Block (Experimental Arm) | Rectus Sheath Block With Pectointercostal Fascial Plane Block (Placebo Arm) | Total |
|---|---|---|---|
| Age, Continuous | 67.5 years STANDARD_DEVIATION 9.51 | 67.3 years STANDARD_DEVIATION 8.79 | 67.42 years STANDARD_DEVIATION 9.08 |
| Anxiety diagnosis | 2 Participants | 5 Participants | 7 Participants |
| Aortic crossclamp time (hours) | 1.47 hours STANDARD_DEVIATION 0.53 | 1.32 hours STANDARD_DEVIATION 0.59 | 1.38 hours STANDARD_DEVIATION 0.57 |
| Body Mass Index | 28.9 kg/m2 STANDARD_DEVIATION 4.31 | 30.8 kg/m2 STANDARD_DEVIATION 6.17 | 29.82 kg/m2 STANDARD_DEVIATION 5.36 |
| Cardiopulmonary bypass time (hours) | 1.85 hours STANDARD_DEVIATION 0.62 | 1.78 hours STANDARD_DEVIATION 0.73 | 1.78 hours STANDARD_DEVIATION 0.68 |
| Chronic Kidney Disease/End Stage Renal Disease diagnosis | 5 Participants | 4 Participants | 9 Participants |
| Chronic Obstructive Pulmonary Disease diagnosis | 0 Participants | 1 Participants | 1 Participants |
| Coronary Artery Bypass Graft Surgery | 18 Participants | 20 Participants | 38 Participants |
| Coronary Artery Bypass Graft with single valve | 3 Participants | 3 Participants | 6 Participants |
| Coronary artery disease diagnosis | 23 Participants | 25 Participants | 48 Participants |
| Depression diagnosis | 4 Participants | 5 Participants | 9 Participants |
| Diabetes diagnosis | 8 Participants | 7 Participants | 15 Participants |
| History of Cerebral Vascular Accident | 3 Participants | 1 Participants | 4 Participants |
| Hypertension diagnosis | 20 Participants | 21 Participants | 41 Participants |
| Intraoperative oral morphine equivalents (mg) | 297.44 mg STANDARD_DEVIATION 65.13 | 276.64 mg STANDARD_DEVIATION 102.9 | 287.04 mg STANDARD_DEVIATION 86.05 |
| Neuropathy diagnosis | 2 Participants | 4 Participants | 6 Participants |
| Peripheral Vascular Disease diagnosis | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 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 | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 30 Participants | 30 Participants | 60 Participants |
| Region of Enrollment United States | 30 participants | 30 participants | 60 participants |
| Sex: Female, Male Female | 8 Participants | 9 Participants | 17 Participants |
| Sex: Female, Male Male | 22 Participants | 21 Participants | 43 Participants |
| Single valve case | 9 Participants | 7 Participants | 16 Participants |
| Total surgical time (hours) | 4.88 hours STANDARD_DEVIATION 1.15 | 4.6 hours STANDARD_DEVIATION 1.3 | 4.73 hours STANDARD_DEVIATION 1.21 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 1 / 32 |
| other Total, other adverse events | 0 / 30 | 0 / 32 |
| serious Total, serious adverse events | 0 / 30 | 1 / 32 |
Outcome results
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.
Time frame: 24 hours after extubation
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rectus Sheath Block With PIFB (Experimental Arm) | Pain Scores at Rest Within the First 24 Hours After Extubation | 79.25 Numeric rating score * hours. |
| Rectus Sheath Block With PIFB (Placebo Arm) | Pain Scores at Rest Within the First 24 Hours After Extubation | 102 Numeric rating score * hours. |
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.
Time frame: 24 hours after extubation
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rectus Sheath Block With PIFB (Experimental Arm) | Pain Scores With Deep Breathing Within the First 24 Hours After Extubation | 141.5 Numeric rating score * hours. |
| Rectus Sheath Block With PIFB (Placebo Arm) | Pain Scores With Deep Breathing Within the First 24 Hours After Extubation | 144 Numeric rating score * hours. |
Primary
Total Cumulative Opioid Consumption
Total cumulative opioid consumption at 24 hours
Time frame: 24 hours post-operatively
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rectus Sheath Block With PIFB (Experimental Arm) | Total Cumulative Opioid Consumption | 55.25 Oral morphine equivalents (mg) |
| Rectus Sheath Block With PIFB (Placebo Arm) | Total Cumulative Opioid Consumption | 58.75 Oral morphine equivalents (mg) |
Primary
Total Cumulative Opioid Consumption
Total cumulative opioid consumption at 48 hours
Time frame: 48 hours post-operatively
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rectus Sheath Block With PIFB (Experimental Arm) | Total Cumulative Opioid Consumption | 96.75 Oral morphine equivalents (mg) |
| Rectus Sheath Block With PIFB (Placebo Arm) | Total Cumulative Opioid Consumption | 95 Oral morphine equivalents (mg) |
Secondary
Hospital Length of Stay
Hospital Length of Stay in hours, as measured by anesthesia stop until discharge from the hospital.
Time frame: Time from anesthesia stop to hospital discharge, typically one week
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rectus Sheath Block With PIFB (Experimental Arm) | Hospital Length of Stay | 97.21 Hours |
| Rectus Sheath Block With PIFB (Placebo Arm) | Hospital Length of Stay | 97.31 Hours |
Secondary
ICU Length of Stay
ICU Length of Stay in hours, as measured by anesthesia stop until transfer out of the ICU.
Time frame: Time from anesthesia stop to transfer out of ICU, typically 24 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rectus Sheath Block With PIFB (Experimental Arm) | ICU Length of Stay | 20.69 Hours |
| Rectus Sheath Block With PIFB (Placebo Arm) | ICU Length of Stay | 25.77 Hours |
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.
Time frame: 24 hours after extubation
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rectus Sheath Block With PIFB (Experimental Arm) | QoR-15 (Quality of Recovery) Score | 83 score on a scale |
| Rectus Sheath Block With PIFB (Placebo Arm) | QoR-15 (Quality of Recovery) Score | 79.5 score on a scale |
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).
Time frame: ICU arrival until extubation
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rectus Sheath Block With PIFB (Experimental Arm) | Time From ICU Arrival to Liberation From Mechanical Ventilation | 3.87 hours |
| Rectus Sheath Block With PIFB (Placebo Arm) | Time From ICU Arrival to Liberation From Mechanical Ventilation | 3.87 hours |
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).
Time frame: 1 hour post-extubation
Population: 7 total patients did not have IS completed at 1 hour by ICU nursing due to either need for bipap/unknown reason.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rectus Sheath Block With PIFB (Experimental Arm) | Vital Capacity Change From Baseline on Incentive Spirometry | 0.25 Percent of baseline IS |
| Rectus Sheath Block With PIFB (Placebo Arm) | Vital Capacity Change From Baseline on Incentive Spirometry | .24 Percent of baseline IS |
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).
Time frame: 24 hours post-extubation
Population: 7 total patients did not have IS completed at 24 hours by ICU nursing due to unknown reasons.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rectus Sheath Block With PIFB (Experimental Arm) | Vital Capacity Change From Baseline on Incentive Spirometry | .32 Percent of baseline IS |
| Rectus Sheath Block With PIFB (Placebo Arm) | Vital Capacity Change From Baseline on Incentive Spirometry | .30 Percent of baseline IS |
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).
Time frame: 3 hours post-extubation
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rectus Sheath Block With PIFB (Experimental Arm) | Vital Capacity Change From Baseline on Incentive Spirometry | .26 Percent of baseline IS |
| Rectus Sheath Block With PIFB (Placebo Arm) | Vital Capacity Change From Baseline on Incentive Spirometry | .27 Percent of baseline IS |
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).
Time frame: 12 hours post-extubation
Population: 3 total patients did not have IS completed at 12 hours by ICU nursing for unknown reasons
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rectus Sheath Block With PIFB (Experimental Arm) | Vital Capacity Change From Baseline on Incentive Spirometry | .28 Percent of baseline IS |
| Rectus Sheath Block With PIFB (Placebo Arm) | Vital Capacity Change From Baseline on Incentive Spirometry | .33 Percent of baseline IS |