NCT03521167

Multimodal Analgesia Versus Traditional Opiate Based Analgesia

Multimodal Analgesia Versus Traditional Opiate Based Analgesia and Cardiac Surgery Outcome

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 225 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiac Surgery

Interventions

Type	Name	Description
DRUG	Ketamine	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.
DRUG	Lidocaine	Intraoperatively use. start lidocaine infusion at 2mg/min after anesthesia induction, and continue up to 1 hour prior to extubation.
DRUG	Dexmedetomidine	Intraoperatively use. start dexmedetomidine infusion at 0.5 mcg/kg/min after anesthesia induction, and continue up to 1 hour prior to extubation.
DRUG	Gabapentin	Postoperatively use. 300 mg PO TID starting POD1 until discharge Use lower dose for \>65y or if patient having significant sedation/dizziness
DRUG	Tylenol	Postoperatively use. 1000 mg PO Q8hr starting POD0 until discharge (max 3000 mg in 24hrs) Reduce to 650 mg PO Q6h if \<70kg
DRUG	Gabapentin Pill	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
DRUG	Tylenol Pill	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)

Timeline

• Start date: 2018-05-01
• Primary completion: 2019-05-01
• Completion: 2019-12-30
• First posted: 2018-05-11
• Last updated: 2018-05-11