Multimodal Analgesia Versus Traditional Opiate Based Analgesia

NCT03521167 | Unknown

• 1 other identifier: MAvsTOBA
• Study Type: interventional
• Target: 225
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

• Evaluation of analgesic effect

  Evaluation of analgesic effect by Visual Analogue Scale

  Within 3 months after surgery

Secondary Outcomes (2)

• Additional opioid consumption

  Within 3 days after operation

• postoperative delirium

  Within 3 days after operation

Study Arms (3)

T

NO INTERVENTION

traditional opioid based regimen

MD

ACTIVE COMPARATOR

multimodal group with dexmedetomidine

Drug: Ketamine; Drug: Lidocaine; Drug: Dexmedetomidine; Drug: Gabapentin; Drug: Tylenol; Drug: Gabapentin Pill; Drug: Tylenol Pill

M

PLACEBO COMPARATOR

multimodal with saline placebo

Drug: Ketamine; Drug: Lidocaine; Drug: Gabapentin; Drug: Tylenol; Drug: Gabapentin Pill; Drug: Tylenol Pill

Interventions

Ketamine DRUG

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.

M; MD

Lidocaine DRUG

Intraoperatively use. start lidocaine infusion at 2mg/min after anesthesia induction, and continue up to 1 hour prior to extubation.

M; MD

Dexmedetomidine DRUG

Intraoperatively use. start dexmedetomidine infusion at 0.5 mcg/kg/min after anesthesia induction, and continue up to 1 hour prior to extubation.

MD

Gabapentin DRUG

Postoperatively use. 300 mg PO TID starting POD1 until discharge Use lower dose for \>65y or if patient having significant sedation/dizziness

M; MD

Tylenol DRUG

Postoperatively use. 1000 mg PO Q8hr starting POD0 until discharge (max 3000 mg in 24hrs) Reduce to 650 mg PO Q6h if \<70kg

M; MD

Gabapentin Pill DRUG

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

M; MD

Tylenol Pill DRUG

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)

M; MD

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA II-III Grade
• BMI 18-31kg/m2
• Adult patients presenting for on-pump cardiac surgery through median sternotomy

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

MeSH Terms

Interventions

Ketamine; Lidocaine; Dexmedetomidine; Gabapentin; Acetaminophen

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Lin Jin, PHD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kefang Guo, PHD

CONTACT

+86-13817706936; drguokefang@foxmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2018
• First Posted: May 11, 2018
• Study Start: May 1, 2018
• Primary Completion: May 1, 2019
• Study Completion: December 30, 2019
• Last Updated: May 11, 2018

Record last verified: 2018-04