Multimodal Analgesia in Cardiac Surgery (Pilot Study)

July 9, 2018 updated by: Virginia Commonwealth University
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Drug: Unrestricted Fentanyl
No changes to current practices, using unlimited narcotic medications intraoperatively.
Other Names:
  • Unlimited intraoperative opiates
Experimental: Lidocaine, Dexmedetomidine and 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.
Drug: Lidocaine
This model would use a combination of intravenous (Dexmedetomidine, Ketamine, Lidocaine) and Spinal (Morphine) drugs.
Other Names:
  • IV Lidocaine
Drug: Ketamine
This model would use a combination of intravenous (Dexmedetomidine, Ketamine, Lidocaine) and Spinal (Morphine) drugs.
Drug: Precedex
This model would use a combination of intravenous (Dexmedetomidine, Ketamine, Lidocaine) and Spinal (Morphine) drugs.
Other Names:
  • IV Precedex
Drug: Duramorph
This model would use a combination of intravenous (Dexmedetomidine, Ketamine, Lidocaine) and Spinal (Morphine) drugs.
Other Names:
  • Spinal Duramorph

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Scores - Numerical Rating Scale, 0-10
Time Frame: 24 hours
Pain scores recorded 24 hours post extubation by acute pain services nurses (who will be blinded)
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Opioid Consumption
Time Frame: 24 hours, 48 hours, 72 hours
Opioid consumption measured in oral morphine equivalents
24 hours, 48 hours, 72 hours
Patient Satisfaction
Time Frame: 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)
24 hours, 48 hours, 72 hours, 7 days, 30 days
Extubation
Time Frame: Hours from arrival to ICU to endotracheal extubation (maximum of 12 hours)
Time from arrival to ICU to extubation
Hours from arrival to ICU to endotracheal extubation (maximum of 12 hours)
ICU Length of Stay
Time Frame: Days from arrival to ICU to transfer to step down or floor level of care (maximum of 30 days)
Days from arrival to ICU to transfer to step down or floor level of care (maximum of 30 days)
Delirium Scores
Time Frame: 24, 48 and 72 hours
CAM-ICU scores at above time points
24, 48 and 72 hours
Ionotropic Requirement
Time Frame: Total amount ionotropes required intraoperatively (mcg); total amount ionotropes required from time of admission to ICU postoperatively to discharge from hospital (maximum 30 days)
Total amount ionotropes required
Total amount ionotropes required intraoperatively (mcg); total amount ionotropes required from time of admission to ICU postoperatively to discharge from hospital (maximum 30 days)
Bowel Function
Time Frame: Will determine each day postoperatively if patient has had a bowel movement, measured in days (maximum 30 days)
Bowel Function
Will determine each day postoperatively if patient has had a bowel movement, measured in days (maximum 30 days)
Ionotropic Requirement
Time Frame: 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)
Total duration ionotropes intraoperatively (hours); total amount ionotropes required from time of admission to ICU postoperatively to discharge from hospital (hours), (maximum 30 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Commonwealth University

Investigators

  • Principal Investigator: Praveen Prasanna, MD, Virginia Commonwealth University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 11, 2016

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

March 9, 2016

First Submitted That Met QC Criteria

April 5, 2016

First Posted (Estimate)

April 12, 2016

Study Record Updates

Last Update Posted (Actual)

August 7, 2018

Last Update Submitted That Met QC Criteria

July 9, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM20004692

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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