Multimodal Analgesia Versus Traditional Opiate Based Analgesia

Study Overview
=================
Brief Summary
-----------------
Pain after cardiac surgery can be moderate to severe with incisions to the sternum and lower extremities, and also the placement of chest tubes. Postoperative pain may contribute to delirium, stress, myocardial oxygen demand supply imbalance, etc. Traditionally postoperative pain management after cardiac surgery has been based on opiate analgesics. However, opiates have many deleterious side effects including nausea/vomiting, ileus, bladder dysfunction, and respiratory depression, which substantially influence patient recovery and may delay discharge after surgery. The current study is designed to evaluate if an opiate sparing multimodal regimen of tylenol, gabapentin, ketamine, lidocaine and dexmedetomidine provided better analgesic effect (pain score, postoperative PCA opioid dose), less side effects (PONV) and improved cardiac surgery outcome (delirium, a-fib, AKI, dysglycemia) compared to a traditional fentanyl and hydromorphine regimen after cardiac surgery. Additionally, it aims to investigate if the benefit of multimodal regimen is achieved by combination of all drugs or all drugs except dexmedetomodine by introducing third group of study patients who will be randomized to all interventions except saline placebo instead of dexmedetomodine infusion.

Official Title
-----------------
Multimodal Analgesia Versus Traditional Opiate Based Analgesia and Cardiac Surgery Outcome

Conditions
-----------------
Cardiac Surgery

Intervention / Treatment
-----------------
* Drug: Ketamine
* Drug: Lidocaine
* Drug: Dexmedetomidine
* Drug: Gabapentin
* Drug: Tylenol
* Drug: Gabapentin Pill
* Drug: Tylenol Pill


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA II-III Grade BMI 18-31kg/m2 Adult patients presenting for on-pump cardiac surgery through median sternotomy Exclusion Criteria: Cardiac surgery without sternotomy emergency surgery h/o allergy to any of the medications in the research protocol hepatic disease with elevated liver enzymes (preoperative SGPT and SGOT elevated to 1.5 times maximum normal value) pregnancy unable to give consent preoperative mental disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: T<br>traditional opioid based regimen | |
| Active Comparator: MD<br>multimodal group with dexmedetomidine | Drug: Ketamine<br>* Intraoperatively use. 0.5 mg/kg with induction bolus, followed by 5mcg/kg/min infusion after induction. Continue up to 1 hour prior to extubation. maximum total dose 3mg/kg.<br>Drug: Lidocaine<br>* Intraoperatively use. start lidocaine infusion at 2mg/min after anesthesia induction, and continue up to 1 hour prior to extubation.<br>Drug: Dexmedetomidine<br>* Intraoperatively use. start dexmedetomidine infusion at 0.5 mcg/kg/min after anesthesia induction, and continue up to 1 hour prior to extubation.<br>Drug: Gabapentin<br>* Postoperatively use. 300 mg PO TID starting POD1 until discharge Use lower dose for >65y or if patient having significant sedation/dizziness<br>Drug: Tylenol<br>* Postoperatively use. 1000 mg PO Q8hr starting POD0 until discharge (max 3000 mg in 24hrs) Reduce to 650 mg PO Q6h if <70kg<br>Drug: Gabapentin Pill<br>* Pre-operatively use. 300mg PO up to 1 hour before OR time Reduce to 100 mg PO in patients >65y or with GFR < 50 Consider dose reduction in patients with sleep apnea<br>Drug: Tylenol Pill<br>* Pre-operatively use. 1000 mg PO up to 1 hour before OR time Reduce to 650 mg PO if <70kg Don't use if h/o liver disease or anticipated liver injury (right heart failure, pulmonary hypertension, etc leading to systemic venous congestion)<br>|
| Placebo Comparator: M<br>multimodal with saline placebo | Drug: Ketamine<br>* Intraoperatively use. 0.5 mg/kg with induction bolus, followed by 5mcg/kg/min infusion after induction. Continue up to 1 hour prior to extubation. maximum total dose 3mg/kg.<br>Drug: Lidocaine<br>* Intraoperatively use. start lidocaine infusion at 2mg/min after anesthesia induction, and continue up to 1 hour prior to extubation.<br>Drug: Gabapentin<br>* Postoperatively use. 300 mg PO TID starting POD1 until discharge Use lower dose for >65y or if patient having significant sedation/dizziness<br>Drug: Tylenol<br>* Postoperatively use. 1000 mg PO Q8hr starting POD0 until discharge (max 3000 mg in 24hrs) Reduce to 650 mg PO Q6h if <70kg<br>Drug: Gabapentin Pill<br>* Pre-operatively use. 300mg PO up to 1 hour before OR time Reduce to 100 mg PO in patients >65y or with GFR < 50 Consider dose reduction in patients with sleep apnea<br>Drug: Tylenol Pill<br>* Pre-operatively use. 1000 mg PO up to 1 hour before OR time Reduce to 650 mg PO if <70kg Don't use if h/o liver disease or anticipated liver injury (right heart failure, pulmonary hypertension, etc leading to systemic venous congestion)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of analgesic effect | Evaluation of analgesic effect by Visual Analogue Scale | Within 3 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Additional opioid consumption | assessed by daily sufentanil PCIA dose | Within 3 days after operation | 
| postoperative delirium | evaluated by CAM-ICU criteria | Within 3 days after operation |