Pectointercostal Fascial Plane Block (PIFB) Alone Versus PIFB With Rectus Sheath Block (RSB) in Cardiac Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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This is a single center, prospective, randomized, controlled, double-blinded study. We anticipate recruitment of 50-60 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.

Official Title
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A Comparison of the Analgesic Effects of Pectointercostal Fascial Plane Block (PIFB) Alone Versus PIFB With Rectus Sheath Block (RSB) in Cardiac Surgery: a Prospective, Randomized Controlled Trial.

Conditions
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Coronary Artery Disease, Postoperative Pain, Respiratory Failure

Intervention / Treatment
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* Drug: Rectus sheath block with bupivacaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| Experimental: Rectus sheath block block with PIFB (experimental arm)<br>PIFB with local anesthetic with RSB with local anesthetic (bupivacaine) | Drug: Rectus sheath block with bupivacaine<br>* Rectus sheath block with local anesthetic versus sham block with saline<br>* Other names: Rectus sheath block with saline placebo;|
| Placebo Comparator: Rectus sheath block with PIFB (placebo arm)<br>PIFB with local anesthetic with RSB placebo (saline) | Drug: Rectus sheath block with bupivacaine<br>* Rectus sheath block with local anesthetic versus sham block with saline<br>* Other names: Rectus sheath block with saline placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scores on a 0-10 visual analog scale at rest and with deep breathing | Pain scores on a 0-10 visual analog scale at rest and with deep breathing | 1 hour post-extubation | 
| Pain scores on a 0-10 visual analog scale at rest and with deep breathing | Pain scores on a 0-10 visual analog scale at rest and with deep breathing | 3 hours post-extubation | 
| Pain scores on a 0-10 visual analog scale at rest and with deep breathing | Pain scores on a 0-10 visual analog scale at rest and with deep breathing | 6 hours post-extubation | 
| Pain scores on a 0-10 visual analog scale at rest and with deep breathing | Pain scores on a 0-10 visual analog scale at rest and with deep breathing | 12 hours post-extubation | 
| Pain scores on a 0-10 visual analog scale at rest and with deep breathing | Pain scores on a 0-10 visual analog scale at rest and with deep breathing | 18 hours post-extubation | 
| Pain scores on a 0-10 visual analog scale at rest and with deep breathing | Pain scores on a 0-10 visual analog scale at rest and with deep breathing | 24 hours post-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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative total opioid consumption | Intraoperative total opioid consumption | From anesthesia start to anesthesia stop | 
| Time from ICU arrival to liberation from mechanical ventilation | Time from ICU arrival to liberation from mechanical ventilation | ICU arrival until extubation | 
| Vital capacity change from baseline on incentive spirometry | Vital capacity change from baseline on incentive spirometry | 1 hour post-extubation | 
| Vital capacity change from baseline on incentive spirometry | Vital capacity change from baseline on incentive spirometry | 3 hours post-extubation | 
| Vital capacity change from baseline on incentive spirometry | Vital capacity change from baseline on incentive spirometry | 12 hours post-extubation | 
| Vital capacity change from baseline on incentive spirometry | Vital capacity change from baseline on incentive spirometry | 24 hours post-extubation | 
| QoR-15 (Quality of Recovery) score | QoR-15 (Quality of Recovery) score | 24 hours after extubation | 
| ICU Length of Stay | ICU Length of Stay | Time from anesthesia stop to transfer out of ICU, typically 24 hours | 
| Hospital Length of Stay | Hospital Length of Stay | Time from anesthesia stop to hospital discharge, typically one week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postoperative pain, local anesthetic, regional anesthesia, quality of recovery, coronary artery bypass graft