Pecto-Intercostal Fascial Block for Postoperative Analgesia After Cardiac Surgery

Study Overview
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Brief Summary
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The purpose of this study is to determine whether administration of a pecto-intercostal fascial plane block (PIFB) with bupivacaine is a more effective therapy for postoperative analgesia after cardiac surgery as compared to patients who receive a sham block of normal saline.

Detailed Description
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The purpose of this study is to determine whether administration of a pecto-intercostal fascial plane block (PIFB) with bupivacaine is a more effective therapy for postoperative analgesia after cardiac surgery as compared to patients who receive a sham block of normal saline. Specific Aim 1: To determine whether or not a PIFB with bupivacaine can reduce postoperative pain after cardiac surgery. This will be assessed through: (Aim 1A) opioid consumption in the first 48 hours postoperatively (Aim 1B) patient self-reported pain scores during their hospital stay Specific Aim 2: To estimate the effect size in order to obtain information that can be used to power future research on the use of regional modalities of analgesia for cardiac surgeries.

Official Title
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Pecto-Intercostal Fascial Block for Postoperative Analgesia After Cardiac Surgery

Conditions
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Coronary Artery Disease, Sternal Pain

Intervention / Treatment
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* Drug: Bupivacaine Group
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Patients 18 years of age or older Undergoing cardiac surgery with sternotomy, limited to CABG, CABG+valve surgeries and isolated valve surgeries. Exclusion Criteria Current participation in another interventional study Preoperative LVEF < 30% Use of mechanical circulatory support Emergent procedures Aortic surgeries, transplants ventricular assist device insertions, bentall, or grafts Minimally invasive cardiac procedures or those with thoracotomy approach Patients receiving other modalities of regional anesthesia like intrathecal morphine Chronic opioid use for chronic pain conditions with tolerance (total daily dose of an opioid at or more than 30 mg morphine equivalent for more than one month within the past year) Current use of TCA, gabapentin, or pregabalin Hypersensitivity to bupivacaine Women who are pregnant or breastfeeding Non English speaking

Ages Eligible for Study
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Minimum Age: 18 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: Interventional Bupivacaine<br>20 cc of 0.25% bupivacaine on each side of the sternum at two time points after surgery and POD1 | Drug: Bupivacaine Group<br>* 20cc bupivacaine hydrochloride will be administered on each side at two different time points (immediately post operatively and on day 1).<br>|
| Placebo Comparator: Interventional Placebo<br>20 cc of saline on each side of the sternum at two time points after surgery and POD1 | Other: Placebo<br>* 20cc placebo (0.9% NaCl) will be administered on each side at two different time points (immediately post operatively and on day 1).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid Consumption | Total opioid consumption in the first 48 hours post-operatively, measured as milligram morphine equivalents (MME). | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Scores | Patient reported pain scores on a scale from 0-10 until discharge for the index admission. Where the minimum score is 0 and, the maximum score is 10. A score of 0 means no pain and the higher the score, the greater the pain intensity, with a score of 10 means worse imaginable pain. Pain scores recorded at 6-8 hourly intervals every day until discharge or 4 days, computed as an average pain score. | At 6-8 hourly intervals every day until discharge or 4 days | 
| ICU Length of Stay | Total duration of stay in ICU for the index admission | Time of ICU admission until time of discharge to hospital floor; through the hospital stay, an average of 5 days | 
| Hospital Length of Stay | Their stay in the hospital for the index admission | Measured in days admitted in the hospital, an average of 5 days | 
| Number of Participants With Complications | This includes infection, hematoma, local anesthetic systemic toxicity directly related to the block or the drug used in the block | 7 days post-op on an average | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiopulmonary Bypass, Cardiac Surgery, Sternotomy