Effectiveness of an Opioid Sparing Pain Regimen in Cardiac Surgery
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Oral Gabapentin and Intravenous Acetaminophen (IV APAP); Opiate based pain regimen.
Intervention description: Scheduled multimodal pain regimen consisting of oral Gabapentin paired with intravenous Acetaminophen following cardiopulmonary bypass surgery.; Standard of care opiate based pain regimen.
Intervention MeSH terms: Acetaminophen; Gabapentin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: cardiac; surgery; pain

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.
    

Eligibility 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 pregabalin

          5. Active substance abuse

          6. Current self- report of alcoholism

          7. End stage renal disease

          8. Active renal dialysis therapy