Pecto-intercostal Fascial Block (PIFB) for Postop Analgesia Following Sternotomy in Cardiac Surgery Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pecto-intercostal Fascial Block With Perineural Adjuvants for Postoperative Analgesia Following Sternotomy in Patients Undergoing Cardiac Surgery

Conditions
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Analgesia, Sternotomy

Intervention / Treatment
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* Drug: Pecto-intercostal Fascial Block (PIFB)
* Drug: PIFB with adjuvants


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pecto-intercostal Fascial Block (PIFB)<br>Subjects in this arm receive standard of care PIFB after surgery | Drug: Pecto-intercostal Fascial Block (PIFB)<br>* PIFB done with bupivacaine and epinephrine<br>|
| Experimental: PIFB with adjuvants<br>Subjects in this arm receive standard of care PIFB with additional medications after surgery | Drug: PIFB with adjuvants<br>* PIFB with bupivacaine, epinephrine, clonidine, and dexamethasone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve (AUC) Pain Score | 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. | 6 hours after block placement | 
| AUC Pain Score | 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 | 
| AUC Pain Score | 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 | 
| AUC Pain Score | 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 | 
| AUC Pain Score | 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. | 36 hours after block placement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-reported 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 NRS Pain Scores at Rest | Pain scores range from 0 to 10 with higher scores denoting more pain. | 6, 12, 18, 24, and 36 hours after block placement | 
| Average Cumulative Opioid Consumption | In milligrams | 36 hours after block placement | 
| Average Time to First Opioid Administration | Postoperative after extubation in minutes | Up to 36 hours after block placement | 
| Average Time to Extubation | In minutes | Up to 36 hours after block placement | 
| Duration of Intensive Care Unit (ICU) Admission | Average number of hours | Up to 36 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. | 6, 12, 18, 24, and 36 hours after block placement | 
| Safety Outcome: Nausea Incidence | Average number of incidences | Up to 36 hours after block placement | 
| Safety Outcome: Vomiting Incidence | Average number of incidences | Up to 36 hours after block placement | 
| Safety Outcome: Postoperative Delirium Incidence | Average number of incidences | Up to 36 hours after block placement | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pecto-intercostal Fascial Block, Postoperative, Pain, Cardiac Surgery