Multimodal Analgesia in Cardiac Surgery (Pilot Study)

Study Overview
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Brief Summary
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The investigators objective is to assess the effectiveness of an opioid sparing multimodal approach for enhancing the recovery in Cardiac Surgical patients. This model would use a combination of intravenous (Dexmedetomidine, Ketamine, Lidocaine) and Spinal (Morphine) drugs.

Detailed Description
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Cardiac surgery is associated with significant acute pain and a proportion of these patients will develop chronic pain. Opioids are the main stay of analgesia in cardiac surgery because of the safer hemodynamic profile and sedation. However high dose narcotic use is associated with a variety of unwanted side effects prolonging postoperative recovery. There is growing evidence for the effectiveness of multimodal approach utilizing opiate sparing techniques for enhancing patient recovery following surgery. Early extubation has been associated with improved patient outcome and cost effectiveness in cardiac surgery. The investigators objective is to assess the effectiveness of an opioid sparing multimodal approach for enhancing the recovery in Cardiac Surgical patients. This model would use a combination of intravenous (Dexmedetomidine, Ketamine, Lidocaine) and Spinal (Morphine) drugs. All of the above anesthetic drugs have opioid sparing effect in surgical Patients. Dexmedetomidine use has been associated with decreased cardiac arrhythmias and improved neurological outcome in cardiac surgical patients. Ketamine has been linked with attenuation of postoperative cognitive dysfunction after cardiac surgery. Both intravenous lidocaine and spinal morphine have been shown to reduce opioid consumption in the perioperative period.

Official Title
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Multimodal Analgesia in Cardiac Surgery (Pilot Study)

Conditions
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Heart Diseases

Intervention / Treatment
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* Drug: Lidocaine
* Drug: Unrestricted Fentanyl
* Drug: Ketamine
* Drug: Precedex
* Drug: Duramorph


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elective CABGs and/or Valve replacements, ≥ 18 years old Exclusion Criteria: Re-do cardiac surgery, Acute endocarditis, Circulatory arrest, Emergent cases, Shock, Left Ventricular Assist Device, Transplantation, Transcatheter Aortic Valve Replacement, contraindications for Spinal including coagulopathy and Clopidogrel <7days, psychosis, known allergy to any of the study drugs, Preoperative liver dysfunction (AST/ALT > 2 times normal) and Renal dysfunction (Cr > 2 mg/dL), inability to administer spinal anesthetic, preoperative opioid use, patients who are unable to give their own consent, expected prolonged intubation postoperatively (>12 hrs), prisoners, pregnancy

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Unrestricted Fentanyl<br>Will receive injection of sterile saline (2cc) in lower back area (to minimize participant bias) and unrestricted amount of intraoperative opioids (fentanyl) at the discretion of the Anesthesiologist. Both groups will receive General Anesthesia with volatile agents and single dose of iv Tylenol intraoperatively. Both groups of patients will be transported to Intensive Care Unit (ICU) on Dexmedetomidine (dose range 0.25 - 0.7 mcg/kg/hr). Dose titration is based on sedation level and hemodynamic goals set by Cardiac Anesthesiologist. | Drug: Unrestricted Fentanyl<br>* No changes to current practices, using unlimited narcotic medications intraoperatively.<br>* Other names: Unlimited intraoperative opiates;|
| Experimental: Lidocaine, Dexmedetomidine and Ketamine<br>Will receive pre-operative spinal duramorph (4mcg/kg up to max dose of 300mcg), intra-operative intravenous (iv) infusion of Ketamine (0.4 mg/kg/hr), Lidocaine (20 mcg/kg/min) and Dexmedetomidine (0.25 mcg/kg/hr) started after induction of General Anesthesia and maintained through the Cardiopulmonary Bypass (CPB) towards the end of surgery. At this point all infusions will be turned off except Dexmedetomidine. The total intraoperative fentanyl dose will be limited to <250mcg (or 3mcg/kg) and total midazolam to ≤ 2mg in the study group. | Drug: Lidocaine<br>* This model would use a combination of intravenous (Dexmedetomidine, Ketamine, Lidocaine) and Spinal (Morphine) drugs.<br>* Other names: IV Lidocaine;Drug: Ketamine<br>* This model would use a combination of intravenous (Dexmedetomidine, Ketamine, Lidocaine) and Spinal (Morphine) drugs.<br>Drug: Precedex<br>* This model would use a combination of intravenous (Dexmedetomidine, Ketamine, Lidocaine) and Spinal (Morphine) drugs.<br>* Other names: IV Precedex;Drug: Duramorph<br>* This model would use a combination of intravenous (Dexmedetomidine, Ketamine, Lidocaine) and Spinal (Morphine) drugs.<br>* Other names: Spinal Duramorph;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Scores - Numerical Rating Scale, 0-10 | Pain scores recorded 24 hours post extubation by acute pain services nurses (who will be blinded) | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Opioid Consumption | Opioid consumption measured in oral morphine equivalents | 24 hours, 48 hours, 72 hours | 
| Patient Satisfaction | Patient Satisfaction with pain management in first 24 hours post extubation - as measured by acute pain service nurses (who will be blinded) | 24 hours, 48 hours, 72 hours, 7 days, 30 days | 
| Extubation | Time from arrival to ICU to extubation | Hours from arrival to ICU to endotracheal extubation (maximum of 12 hours) | 
| ICU Length of Stay |  | Days from arrival to ICU to transfer to step down or floor level of care (maximum of 30 days) | 
| Delirium Scores | CAM-ICU scores at above time points | 24, 48 and 72 hours | 
| Ionotropic Requirement | Total amount ionotropes required | Total amount ionotropes required intraoperatively (mcg); total amount ionotropes required from time of admission to ICU postoperatively to discharge from hospital (maximum 30 days) | 
| Bowel Function | Bowel Function | Will determine each day postoperatively if patient has had a bowel movement, measured in days (maximum 30 days) | 
| Ionotropic Requirement | Total duration of ionotropic requirement (hours) | Total duration ionotropes intraoperatively (hours); total amount ionotropes required from time of admission to ICU postoperatively to discharge from hospital (hours), (maximum 30 days) |