Analgesia, Sternotomy
Conditions
Keywords
Pecto-intercostal Fascial Block, Postoperative, Pain, Cardiac Surgery
Brief summary
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.
Detailed description
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.
Interventions
DRUGPecto-intercostal Fascial Block (PIFB)
PIFB done with bupivacaine and epinephrine
DRUGPIFB with adjuvants
PIFB with bupivacaine, epinephrine, clonidine, and dexamethasone
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Adults between undergoing cardiac surgery involving sternotomy
Exclusion criteria
* Patients with any contraindications to regional anesthesia, such as history of allergy to amide local anesthetics or any of the perineural adjuvants * existing neurologic deficit in the chest wall; * remaining intubated at the six hour point after block placement * weight under 50kg * undergoing emergency surgical procedures or urgent return to the operating room * active endocarditis or mediastinitis * moderate to severe right ventricular function before or after cardiopulmonary bypass * reliance on mechanical circulatory support devices, such as intra-aortic balloon pump or Impella * reliance on extracorporeal membrane oxygenation * localized or systemic infection * chronic use of high dose opioid analgesics (defined as daily use greater than 30 oral morphine milligram equivalents (OMME) for over one month prior to surgery) * those who are pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve (AUC) Pain Score - Based on Patient-reported Dynamic Numerical Rating Scale (NRS) Pain Scores | 0 to 6 hours after block placement | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety Outcome: Postoperative Delirium Incidence | Up to 36 hours after block placement | Average number of Delirium incidences |
| Patient-reported Numerical Rating Scale (NRS) Pain Scores at Rest | 6 hours after block placement | Pain scores range from 0 to 10 with higher scores denoting more pain. |
| Average Cumulative Opioid Consumption | 36 hours after block placement | Average Cumulative Opioid Consumption in milligrams |
| Average Time to First Opioid Administration | Up to 36 hours after block placement | Average Time to First Opioid Administration - Postoperative after extubation measured in minutes |
| Safety Outcome: Vomiting Incidence | Up to 36 hours after block placement | Average number of Vomiting incidences |
| Duration of Intensive Care Unit (ICU) Admission | Up to 52 hours after block placement | Duration of Intensive Care Unit (ICU) Admission - measured in Average number of hours. |
| Incentive Spirometry Volumes | 6, 12, 18, 24 hours after block placement | 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. |
| Safety Outcome: Nausea Incidence | Up to 36 hours after block placement | Average number of incidences of Nausea |
| Numeric Rating Scale (NRS) Satisfaction With the Analgesic Regimen | 36 hours after block placement | Patient-reported scores range from 0-10 where 0 represents completely unsatisfied and 10 represents completely satisfied. |
| Average Time to Extubation | Up to 36 hours after block placement | Average Time to Extubation - measured in minutes |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 16 |
| 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 | 15 |
| Total | 31 |
Baseline characteristics
| Characteristic | Pecto-intercostal Fascial Block (PIFB) | PIFB With Adjuvants | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 12 Participants | 8 Participants | 20 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 7 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants | 15 Participants | 31 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 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 | 1 Participants | 0 Participants | 1 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 | 15 Participants | 15 Participants | 30 Participants |
| Region of Enrollment United States | 16 Participants | 15 Participants | 31 Participants |
| Sex: Female, Male Female | 3 Participants | 1 Participants | 4 Participants |
| Sex: Female, Male Male | 13 Participants | 14 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 8 |
| other Total, other adverse events | 0 / 12 | 0 / 8 |
| serious Total, serious adverse events | 0 / 12 | 0 / 8 |
Outcome results
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.
Time frame: 18 hours after block placement
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pecto-intercostal Fascial Block (PIFB) | Area Under the Curve (AUC) Pain Score - Based on Patient-reported Dynamic Numerical Rating Scale (NRS) Pain Scores | 4.00 scores on a scale*hour | Standard Deviation 2.09 |
| PIFB With Adjuvants | Area Under the Curve (AUC) Pain Score - Based on Patient-reported Dynamic Numerical Rating Scale (NRS) Pain Scores | 5.12 scores on a scale*hour | Standard Deviation 3.23 |
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.
Time frame: 0 to 6 hours after block placement
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pecto-intercostal Fascial Block (PIFB) | Area Under the Curve (AUC) Pain Score - Based on Patient-reported Dynamic Numerical Rating Scale (NRS) Pain Scores | 6.39 scores on a scale*hour | Standard Deviation 3.23 |
| PIFB With Adjuvants | Area Under the Curve (AUC) Pain Score - Based on Patient-reported Dynamic Numerical Rating Scale (NRS) Pain Scores | 4.22 scores on a scale*hour | Standard Deviation 3.76 |
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.
Time frame: 12 hours after block placement
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pecto-intercostal Fascial Block (PIFB) | Area Under the Curve (AUC) Pain Score - Based on Patient-reported Dynamic Numerical Rating Scale (NRS) Pain Scores | 3.28 scores on a scale*hour | Standard Deviation 2.03 |
| PIFB With Adjuvants | Area Under the Curve (AUC) Pain Score - Based on Patient-reported Dynamic Numerical Rating Scale (NRS) Pain Scores | 4.06 scores on a scale*hour | Standard Deviation 3.65 |
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.
Time frame: 36 hours after block placement
Population: data wasn't collected
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.
Time frame: 24 hours after block placement
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pecto-intercostal Fascial Block (PIFB) | Area Under the Curve (AUC) Pain Score - Based on Patient-reported Dynamic Numerical Rating Scale (NRS) Pain Scores | 3.18 scores on a scale*hour | Standard Deviation 2.19 |
| PIFB With Adjuvants | Area Under the Curve (AUC) Pain Score - Based on Patient-reported Dynamic Numerical Rating Scale (NRS) Pain Scores | 4.71 scores on a scale*hour | Standard Deviation 3.06 |
Secondary
Average Cumulative Opioid Consumption
Average Cumulative Opioid Consumption in milligrams
Time frame: 36 hours after block placement
Population: data wasn't collected
Secondary
Average Time to Extubation
Average Time to Extubation - measured in minutes
Time frame: Up to 36 hours after block placement
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pecto-intercostal Fascial Block (PIFB) | Average Time to Extubation | 276.815 Minutes | Standard Deviation 78.609 |
| PIFB With Adjuvants | Average Time to Extubation | 232.020 Minutes | Standard Deviation 68.689 |
Secondary
Average Time to First Opioid Administration
Average Time to First Opioid Administration - Postoperative after extubation measured in minutes
Time frame: Up to 36 hours after block placement
Population: data not collected
Secondary
Duration of Intensive Care Unit (ICU) Admission
Duration of Intensive Care Unit (ICU) Admission - measured in Average number of hours.
Time frame: Up to 52 hours after block placement
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pecto-intercostal Fascial Block (PIFB) | Duration of Intensive Care Unit (ICU) Admission | 50.620 Hours | Standard Deviation 32.302 |
| PIFB With Adjuvants | Duration of Intensive Care Unit (ICU) Admission | 51.541 Hours | Standard Deviation 59.249 |
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.
Time frame: 6, 12, 18, 24 hours after block placement
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pecto-intercostal Fascial Block (PIFB) | Incentive Spirometry Volumes | 24 hours | 1093.94 Milliliters | Standard Deviation 337.25 |
| Pecto-intercostal Fascial Block (PIFB) | Incentive Spirometry Volumes | 6 hours | 525 Milliliters | Standard Deviation 338.56 |
| Pecto-intercostal Fascial Block (PIFB) | Incentive Spirometry Volumes | Baseline | 2750 Milliliters | Standard Deviation 823.43 |
| Pecto-intercostal Fascial Block (PIFB) | Incentive Spirometry Volumes | 18 hours | 878.79 Milliliters | Standard Deviation 336.08 |
| Pecto-intercostal Fascial Block (PIFB) | Incentive Spirometry Volumes | 12 hours | 968.06 Milliliters | Standard Deviation 287.14 |
| PIFB With Adjuvants | Incentive Spirometry Volumes | 24 hours | 1275 Milliliters | Standard Deviation 498.65 |
| PIFB With Adjuvants | Incentive Spirometry Volumes | 12 hours | 1519.44 Milliliters | Standard Deviation 716.12 |
| PIFB With Adjuvants | Incentive Spirometry Volumes | 18 hours | 1440.63 Milliliters | Standard Deviation 794.07 |
| PIFB With Adjuvants | Incentive Spirometry Volumes | Baseline | 3427.08 Milliliters | Standard Deviation 743.27 |
| PIFB With Adjuvants | Incentive Spirometry Volumes | 6 hours | 1333.33 Milliliters | Standard Deviation 857.97 |
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.
Time frame: 36 hours after block placement
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pecto-intercostal Fascial Block (PIFB) | Numeric Rating Scale (NRS) Satisfaction With the Analgesic Regimen | 7.92 units on a scale | Standard Deviation 1.98 |
| PIFB With Adjuvants | Numeric Rating Scale (NRS) Satisfaction With the Analgesic Regimen | 8.88 units on a scale | Standard Deviation 0.99 |
Secondary
Patient-reported Numerical Rating Scale (NRS) Pain Scores at Rest
Pain scores range from 0 to 10 with higher scores denoting more pain.
Time frame: 6, 12, 18, 24 hours after block placement
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pecto-intercostal Fascial Block (PIFB) | Patient-reported Numerical Rating Scale (NRS) Pain Scores at Rest | 12 hour | 2.67 units on a scale | Standard Deviation 2.02 |
| Pecto-intercostal Fascial Block (PIFB) | Patient-reported Numerical Rating Scale (NRS) Pain Scores at Rest | 24 hour | 3.09 units on a scale | Standard Deviation 2.26 |
| Pecto-intercostal Fascial Block (PIFB) | Patient-reported Numerical Rating Scale (NRS) Pain Scores at Rest | 18 hour | 2.45 units on a scale | Standard Deviation 2.42 |
| Pecto-intercostal Fascial Block (PIFB) | Patient-reported Numerical Rating Scale (NRS) Pain Scores at Rest | 6 hour | 5.25 units on a scale | Standard Deviation 3.22 |
| PIFB With Adjuvants | Patient-reported Numerical Rating Scale (NRS) Pain Scores at Rest | 12 hour | 3.14 units on a scale | Standard Deviation 3.18 |
| PIFB With Adjuvants | Patient-reported Numerical Rating Scale (NRS) Pain Scores at Rest | 6 hour | 3.43 units on a scale | Standard Deviation 4.24 |
| PIFB With Adjuvants | Patient-reported Numerical Rating Scale (NRS) Pain Scores at Rest | 18 hour | 3.5 units on a scale | Standard Deviation 3.25 |
| PIFB With Adjuvants | Patient-reported Numerical Rating Scale (NRS) Pain Scores at Rest | 24 hour | 3.5 units on a scale | Standard Deviation 3.78 |
Secondary
Patient-reported Numerical Rating Scale (NRS) Pain Scores at Rest
Pain scores range from 0 to 10 with higher scores denoting more pain.
Time frame: 6 hours after block placement
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pecto-intercostal Fascial Block (PIFB) | Patient-reported Numerical Rating Scale (NRS) Pain Scores at Rest | 5.25 units on a scale | Standard Deviation 3.22 |
| PIFB With Adjuvants | Patient-reported Numerical Rating Scale (NRS) Pain Scores at Rest | 3.43 units on a scale | Standard Deviation 4.24 |
Secondary
Safety Outcome: Nausea Incidence
Average number of incidences of Nausea
Time frame: Up to 36 hours after block placement
Population: data wasn't collected
Secondary
Safety Outcome: Postoperative Delirium Incidence
Average number of Delirium incidences
Time frame: Up to 36 hours after block placement
Population: data wasn't collected
Secondary
Safety Outcome: Vomiting Incidence
Average number of Vomiting incidences
Time frame: Up to 36 hours after block placement
Population: data wasn't collected