Multimodal Analgesia in Cardiac Surgery (Pilot Study)

Heart Diseases Clinical Trial

Official title:

Multimodal Analgesia in Cardiac Surgery (Pilot Study)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02734940
• Other study ID #: HM20004692
• Status: Terminated
• Phase: Phase 4
• Start date: July 11, 2016
• Est. completion date: February 1, 2017

Study information

• Verified date: July 2018
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: February 1, 2017
• Est. primary completion date: February 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Diseases

Intervention

Drug:
• Lidocaine
This model would use a combination of intravenous (Dexmedetomidine, Ketamine, Lidocaine) and Spinal (Morphine) drugs.
• Unrestricted Fentanyl
No changes to current practices, using unlimited narcotic medications intraoperatively.
• Ketamine
This model would use a combination of intravenous (Dexmedetomidine, Ketamine, Lidocaine) and Spinal (Morphine) drugs.
• Precedex
This model would use a combination of intravenous (Dexmedetomidine, Ketamine, Lidocaine) and Spinal (Morphine) drugs.
• Duramorph
This model would use a combination of intravenous (Dexmedetomidine, Ketamine, Lidocaine) and Spinal (Morphine) drugs.

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Scores - Numerical Rating Scale, 0-10	Pain scores recorded 24 hours post extubation by acute pain services nurses (who will be blinded)	24 hours
Secondary	Postoperative Opioid Consumption	Opioid consumption measured in oral morphine equivalents	24 hours, 48 hours, 72 hours
Secondary	Patient Satisfaction	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
Secondary	Extubation	Time from arrival to ICU to extubation	Hours from arrival to ICU to endotracheal extubation (maximum of 12 hours)
Secondary	ICU Length of Stay		Days from arrival to ICU to transfer to step down or floor level of care (maximum of 30 days)
Secondary	Delirium Scores	CAM-ICU scores at above time points	24, 48 and 72 hours
Secondary	Ionotropic Requirement	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)
Secondary	Bowel Function	Bowel Function	Will determine each day postoperatively if patient has had a bowel movement, measured in days (maximum 30 days)
Secondary	Ionotropic Requirement	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)