Multimodal Analgesia Versus Traditional Opiate Based Analgesia

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.

Intervention / Treatment

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

Condition or Disease

  • Cardiac Surgery

Phase

Study Design

Study type: Interventional
Status: Unknown status
Study results: No Results Available
Age: 18 Years to 80 Years   (Adult, Older Adult)
Enrollment: 225 ()
Funded by: Other

Masking

Clinical Trial Dates

Start date: May 01, 2018
Primary Completion: May 01, 2019
Completion Date: Dec 30, 2019
Study First Posted: May 11, 2018
Results First Posted: Aug 31, 2020
Last Updated: May 11, 2018

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

Eligibility Criteria

Sex: All
Minimum Age: 18
Maximum Age: 80

More Details

NCT Number: NCT03521167
Other IDs: MAvsTOBA
Study URL: https://ClinicalTrials.gov/show/NCT03521167
Last updated: Jan 27, 2021