Pain Control After Minimally Invasive Coronary Artery Bypass Grafting

Study Overview
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Brief Summary
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The purpose of this study is to compare postoperative pain control after minimally invasive coronary artery bypass grafting for patients who receive an intercostal block (an anesthetic medicine injected in an area under the ribs) in the operating room and IV acetaminophen (Tylenol) to those who receive an intercostal block and On-Q pain pump catheter (a balloon pump attached to 2 small tubes near your procedure site that automatically delivers pain medicine).

Official Title
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Optimal Method of Pain Control After Minimally Invasive Coronary Artery Bypass Grafting

Conditions
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Postoperative Pain, Medication Side Effects, Narcotic Requirement

Intervention / Treatment
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* Drug: IV acetaminophen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older Coronary artery disease requiring surgical intervention No prior sternotomy Creatinine within normal limits (0.60 - 1.10 mg/dL) Exclusion Criteria: Less than 18 years of age Inability to provide consent or complete a written survey Previous history of sternotomy Contraindications to MICS-CABG or to any of the components of the 2 analgesic regimens

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IV acetaminophen<br>Patients in this group will receive intraoperative intercostal block + IV acetaminophen (1000 mg every 6 hours for adults and weight-based for any patient under 50 kg) | Drug: IV acetaminophen<br>* Patients randomized to the IV acetaminophen group will receive IV acetaminophen (1000 mg every 6 hours for adults and weight-based for any patient under 50 kg)instead of an On-Q pain pump catheter.<br>* Other names: Ofirmev;|
| No Intervention: On-Q Pain Pump catheter<br>Patients in this group will receive the current standard care which includes an intraoperative intercostal block + On-Q Pain Pump catheter (continuous dosing). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score | Pain scores will be assessed using a Numerical Rating Scale (NRS) (an 11-point scale, 0 through 10, with 0 representing 'No pain' and 10 representing 'Worst imaginable pain'). Pain scores will be entered by nursing staff every 2 hours in ICU, and every 6 hours on the floor for the duration of the hospital stay, an expected average of 4 days. | Participants will be followed for the duration of hospital stay, an expected average of 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication side effects | Any side effects and need for additional narcotic medication will be collected throughout the duration of the hospital stay, an expected average of 4 days. | Participants will be followed for the duration of hospital stay, an expected average of 4 days |