Multimodal Analgesia in Cardiac Surgery (Pilot Study)

Phase 4

Terminated

Conditions: Heart Diseases

Interventions: Drug: Unrestricted Fentanyl
Drug: Lidocaine
Drug: Ketamine
Drug: Precedex
Drug: Duramorph

Registration Number: NCT02734940

Lead Sponsor: Virginia Commonwealth University

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 3

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Unrestricted Fentanyl	Unrestricted Fentanyl	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.
Lidocaine, Dexmedetomidine and Ketamine	Lidocaine	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.
Lidocaine, Dexmedetomidine and Ketamine	Ketamine	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.
Lidocaine, Dexmedetomidine and Ketamine	Duramorph	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.
Lidocaine, Dexmedetomidine and Ketamine	Precedex	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.

Primary Outcome Measures

Name	Time	Method
Pain Scores - Numerical Rating Scale, 0-10	24 hours	Pain scores recorded 24 hours post extubation by acute pain services nurses (who will be blinded)

Secondary Outcome Measures

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