Effectiveness of an Opioid Sparing Pain Regimen in Cardiac Surgery

• Status: Completed
• Trial end date: 2019-07-12
• Target enrollment: 0
• Participant gender: All

Summary

The Inova Heart and Vascular Institute (IHVI) perform over 300 coronary artery bypass graft (CABG) surgeries per year. While opioid medications are the institutional standard of care for post-operative pain therapy little is known about the variation in pain scores, incidence of post- operative complications, and cost of hospitalization when an alternative multimodal pain regimen consisting of oral Gabapentin and intravenous Acetaminophen (IV APAP) is utilized.

The objective is to determine whether there is a substantial difference in pain scores, incidence of post-operative complications, and costs associated with hospitalization when a non-opioid multimodal pain regimen is utilized A single- center, open label, prospective, randomized, controlled clinical trial comprised of 20 total patients who have undergone isolated CABG at the IHVI will be conducted. Separate cohorts will include patients receiving opioid medications post-operatively (Group 1) and patients receiving the non-opioid regimen of oral Gabapentin and IV APAP (Group 2) to be followed for 72 hours post CABG surgery.

Main outcome measures include pain scores in both study groups, requests for breakthrough pain medication in both groups, gastrointestinal and respiratory complications of ileus and reduction in tidal volumes or forced vital capacity (FVC) at baseline and at 72 hours,increase in serum AST/ALT, and comparison of cost of hospitalization between groups.

The objective of this pilot study is to provide evidence that multimodal pain therapy utilizing IV APAP and PO Gabapentin will provide more effective pain relief than standard of care opioids as evidenced by pain scores <2. And the reduced consumption of opioids will lead to a reduction in ileus, no increase in AST/ALT, post-operative tidal volumes as assessed by incentive spirometry comparable to pre- surgical values, while also showing a positive effect on the cost of hospitalization.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Inova Health Care Services
• Treatments: Acetaminophen; Analgesics, Opioid; Gabapentin; gamma-Aminobutyric Acid

Criteria

Inclusion Criteria:

1. Patient between 18 and 85 years old.

2. Elective or urgent surgery requiring sternotomy approach

3. Subject is able to read and has signed and dated the informed consent document including authorization permitting release of personal health information (PHI) approved by the Inova Institutional Review Board (IRB).

Exclusion Criteria:

1. Patients lacking enteral access on post-operative day 0

2. Inability to communicate

3. Active chronic pain with opioid therapy

4. Active chronic use of gabapentin or pregabaldin

5. Active substance abuse

6. Current self- report of alcoholism

7. End stage renal disease

8. Active renal dialysis therapy