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The purpose of this randomized, triple-blinded, prospective, feasibility study is to compare postoperative analgesia provided by Pecto-intercostal Fascial Block (PIFB) when performed with local anesthetic solution with or without perineural adjuvants in patients following cardiac surgery involving sternotomy. The study team hypothesizes that the patients receiving PIFB with bupivacaine with epinephrine, clonidine, and dexamethasone will have lower dynamic pain over the first 36 hours compared to those receiving PIFB with just bupivacaine and epinephrine.
This will be a randomized, triple-blinded, prospective, feasibility trial. Written informed consent will be obtained from all study participants prior to randomization. Patients scheduled to undergo cardiac surgery involving sternotomy at Atrium Health Wake Forest Baptist will be screened for eligibility. These patients will be approached for enrollment by research staff either during their preoperative assessment clinic visit prior to their surgery date, or when admitted as inpatients and scheduled for surgery. Subjects chosen to participate will be randomized into one or other arm and PIFB will be performed after skin closure and before transport from the operating room to the ICU. For patients who are randomized at enrollment but later excluded due to exclusion criteria prior to block placement, their randomization assignment will be replaced at the end of the initial recruitment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pecto-intercostal Fascial Block (PIFB) | Active Comparator | Subjects in this arm receive standard of care PIFB after surgery |
|
| PIFB with adjuvants | Experimental | Subjects in this arm receive standard of care PIFB with additional medications after surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pecto-intercostal Fascial Block (PIFB) | Drug | PIFB done with bupivacaine and epinephrine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve (AUC) Pain Score - Based on Patient-reported Dynamic Numerical Rating Scale (NRS) Pain Scores | Based on patient-reported dynamic Numerical Rating Scale (NRS) pain scores with incentive spirometer (IS) use in subjects that are extubated. Pain scores range from 0 to 10 with higher scores denoting more pain. 0 to 6 hrs after placement. | 0 to 6 hours after block placement |
| Area Under the Curve (AUC) Pain Score - Based on Patient-reported Dynamic Numerical Rating Scale (NRS) Pain Scores | Based on patient-reported dynamic NRS pain scores with incentive spirometer (IS) use in subjects that are extubated. Pain scores range from 0 to 10 with higher scores denoting more pain. | 12 hours after block placement |
| Area Under the Curve (AUC) Pain Score - Based on Patient-reported Dynamic Numerical Rating Scale (NRS) Pain Scores | Based on patient-reported dynamic NRS pain scores with incentive spirometer (IS) use in subjects that are extubated. Pain scores range from 0 to 10 with higher scores denoting more pain. | 18 hours after block placement |
| Area Under the Curve (AUC) Pain Score - Based on Patient-reported Dynamic Numerical Rating Scale (NRS) Pain Scores | Based on patient-reported dynamic NRS pain scores with incentive spirometer (IS) use in subjects that are extubated. Pain scores range from 0 to 10 with higher scores denoting more pain. | 24 hours after block placement |
| Area Under the Curve (AUC) Pain Score - Based on Patient-reported Dynamic Numerical Rating Scale (NRS) Pain Scores | Based on patient-reported dynamic NRS pain scores with incentive spirometer (IS) use in subjects that are extubated. Pain scores range from 0 to 10 with higher scores denoting more pain. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported Numerical Rating Scale (NRS) Pain Scores at Rest | Pain scores range from 0 to 10 with higher scores denoting more pain. | 6 hours after block placement |
| Patient-reported Numerical Rating Scale (NRS) Pain Scores at Rest |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott Coleman, DO | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pecto-intercostal Fascial Block (PIFB) | Subjects in this arm receive standard of care PIFB after surgery Pecto-intercostal Fascial Block (PIFB): PIFB done with bupivacaine and epinephrine |
| FG001 | PIFB With Adjuvants | Subjects in this arm receive standard of care PIFB with additional medications after surgery PIFB with adjuvants: PIFB with bupivacaine, epinephrine, clonidine, and dexamethasone |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pecto-intercostal Fascial Block (PIFB) | Subjects in this arm receive standard of care PIFB after surgery Pecto-intercostal Fascial Block (PIFB): PIFB done with bupivacaine and epinephrine |
| BG001 | PIFB With Adjuvants |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Area Under the Curve (AUC) Pain Score - Based on Patient-reported Dynamic Numerical Rating Scale (NRS) Pain Scores | Based on patient-reported dynamic Numerical Rating Scale (NRS) pain scores with incentive spirometer (IS) use in subjects that are extubated. Pain scores range from 0 to 10 with higher scores denoting more pain. 0 to 6 hrs after placement. | Posted | Mean | Standard Deviation | scores on a scale*hour | 0 to 6 hours after block placement |
|
up to 36 hours postop
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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 | Pecto-intercostal Fascial Block (PIFB) | Subjects in this arm receive standard of care PIFB after surgery Pecto-intercostal Fascial Block (PIFB): PIFB done with bupivacaine and epinephrine |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Scott Coleman, DO | Wake Forest University Health Sciences | 336-716-2712 | srcolema@wakehealth.edu |
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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 11, 2023 | Jan 11, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 23, 2023 | Sep 7, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| D010146 | Pain |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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Patients will be blinded to their treatment arm assignment, as will all research personnel who be responsible for collection of outcome data, as well as the surgeons performing the procedure, and critical care staff caring for the patients in the postoperative period. The anesthesiologist who will be performing the Pecto-intercostal Fascial Block (PIFB) will open the envelope informing them of the arm assignment; they will be the only care providers unblinded.
| PIFB with adjuvants | Drug | PIFB with bupivacaine, epinephrine, clonidine, and dexamethasone |
|
| 36 hours after block placement |
Pain scores range from 0 to 10 with higher scores denoting more pain.
| 6, 12, 18, 24 hours after block placement |
| Average Cumulative Opioid Consumption | Average Cumulative Opioid Consumption in milligrams | 36 hours after block placement |
| Average Time to First Opioid Administration | Average Time to First Opioid Administration - Postoperative after extubation measured in minutes | Up to 36 hours after block placement |
| Average Time to Extubation | Average Time to Extubation - measured in minutes | Up to 36 hours after block placement |
| Duration of Intensive Care Unit (ICU) Admission | Duration of Intensive Care Unit (ICU) Admission - measured in Average number of hours. | Up to 52 hours after block placement |
| Incentive Spirometry Volumes | An incentive spirometer is a handheld medical device that measures the volume of subject's breath. The volume of air displaced is indicated in milliliters on a scale located on the device enclosure. This device measures what is called vital capacity, the amount of air that is breathed in and out of the lungs. | 6, 12, 18, 24 hours after block placement |
| Safety Outcome: Nausea Incidence | Average number of incidences of Nausea | Up to 36 hours after block placement |
| Safety Outcome: Vomiting Incidence | Average number of Vomiting incidences | Up to 36 hours after block placement |
| Safety Outcome: Postoperative Delirium Incidence | Average number of Delirium incidences | Up to 36 hours after block placement |
| Numeric Rating Scale (NRS) Satisfaction With the Analgesic Regimen | Patient-reported scores range from 0-10 where 0 represents completely unsatisfied and 10 represents completely satisfied. | 36 hours after block placement |
Subjects in this arm receive standard of care PIFB with additional medications after surgery
PIFB with adjuvants: PIFB with bupivacaine, epinephrine, clonidine, and dexamethasone
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Primary | Area Under the Curve (AUC) Pain Score - Based on Patient-reported Dynamic Numerical Rating Scale (NRS) Pain Scores | Based on patient-reported dynamic NRS pain scores with incentive spirometer (IS) use in subjects that are extubated. Pain scores range from 0 to 10 with higher scores denoting more pain. | Posted | Mean | Standard Deviation | scores on a scale*hour | 12 hours after block placement |
|
|
|
| Primary | Area Under the Curve (AUC) Pain Score - Based on Patient-reported Dynamic Numerical Rating Scale (NRS) Pain Scores | Based on patient-reported dynamic NRS pain scores with incentive spirometer (IS) use in subjects that are extubated. Pain scores range from 0 to 10 with higher scores denoting more pain. | Posted | Mean | Standard Deviation | scores on a scale*hour | 18 hours after block placement |
|
|
|
| Primary | Area Under the Curve (AUC) Pain Score - Based on Patient-reported Dynamic Numerical Rating Scale (NRS) Pain Scores | Based on patient-reported dynamic NRS pain scores with incentive spirometer (IS) use in subjects that are extubated. Pain scores range from 0 to 10 with higher scores denoting more pain. | Posted | Mean | Standard Deviation | scores on a scale*hour | 24 hours after block placement |
|
|
|
| Primary | Area Under the Curve (AUC) Pain Score - Based on Patient-reported Dynamic Numerical Rating Scale (NRS) Pain Scores | Based on patient-reported dynamic NRS pain scores with incentive spirometer (IS) use in subjects that are extubated. Pain scores range from 0 to 10 with higher scores denoting more pain. | data wasn't collected | Posted | 36 hours after block placement |
|
|
| Secondary | Patient-reported Numerical Rating Scale (NRS) Pain Scores at Rest | Pain scores range from 0 to 10 with higher scores denoting more pain. | Posted | Mean | Standard Deviation | units on a scale | 6 hours after block placement |
|
|
|
| Secondary | Patient-reported Numerical Rating Scale (NRS) Pain Scores at Rest | Pain scores range from 0 to 10 with higher scores denoting more pain. | Posted | Mean | Standard Deviation | units on a scale | 6, 12, 18, 24 hours after block placement |
|
|
|
| Secondary | Average Cumulative Opioid Consumption | Average Cumulative Opioid Consumption in milligrams | data wasn't collected | Posted | 36 hours after block placement |
|
|
| Secondary | Average Time to First Opioid Administration | Average Time to First Opioid Administration - Postoperative after extubation measured in minutes | data not collected | Posted | Up to 36 hours after block placement |
|
|
| Secondary | Average Time to Extubation | Average Time to Extubation - measured in minutes | Posted | Mean | Standard Deviation | Minutes | Up to 36 hours after block placement |
|
|
|
| Secondary | Duration of Intensive Care Unit (ICU) Admission | Duration of Intensive Care Unit (ICU) Admission - measured in Average number of hours. | Posted | Mean | Standard Deviation | Hours | Up to 52 hours after block placement |
|
|
|
| Secondary | Incentive Spirometry Volumes | An incentive spirometer is a handheld medical device that measures the volume of subject's breath. The volume of air displaced is indicated in milliliters on a scale located on the device enclosure. This device measures what is called vital capacity, the amount of air that is breathed in and out of the lungs. | Posted | Mean | Standard Deviation | Milliliters | 6, 12, 18, 24 hours after block placement |
|
|
|
| Secondary | Safety Outcome: Nausea Incidence | Average number of incidences of Nausea | data wasn't collected | Posted | Up to 36 hours after block placement |
|
|
| Secondary | Safety Outcome: Vomiting Incidence | Average number of Vomiting incidences | data wasn't collected | Posted | Up to 36 hours after block placement |
|
|
| Secondary | Safety Outcome: Postoperative Delirium Incidence | Average number of Delirium incidences | data wasn't collected | Posted | Up to 36 hours after block placement |
|
|
| Secondary | Numeric Rating Scale (NRS) Satisfaction With the Analgesic Regimen | Patient-reported scores range from 0-10 where 0 represents completely unsatisfied and 10 represents completely satisfied. | Posted | Mean | Standard Deviation | units on a scale | 36 hours after block placement |
|
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|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | PIFB With Adjuvants | Subjects in this arm receive standard of care PIFB with additional medications after surgery PIFB with adjuvants: PIFB with bupivacaine, epinephrine, clonidine, and dexamethasone | 0 | 8 | 0 | 8 | 0 | 8 |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 18 hour |
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| 24 hour |
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| 12 hours |
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| 18 hours |
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| 24 hours |
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