Effectiveness of an Opioid Sparing Pain Regimen in Cardiac Surgery
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      The Cardiovascular Intensive Care Unit (CVICU) of the Inova Heart and Vascular Institute
      (IHVI) will be the setting of this clinical trial involving two groups of subjects and
      comparing the opiate based standard of care regimen currently adopted (Group 1) at the IHVI
      with a treatment group (Group 2). Group 2 will receive a scheduled multimodal pain regimen
      consisting of PO (pro ora [oral]) Gabapentin paired with intravenous Acetaminophen. Opioids
      will be available for breakthrough pain in the treatment group for pain scores greater than
      4. The outcomes of total opioid consumption and minimum/ maximum pain scores will be assessed
      at the 24 hours, 48 hours, 72 hours, and PRN (pro re nata [as the situation demands])
      timepoints. Assessment will include amount of opioids consumed in both groups as well as
      number of requests for breakthrough pain medication in Group 2.

      Minimum and maximum pain scores in all study groups will be assessed via Numeric Rating Scale
      (0-10) as per Inova Health System (IHS) policy; 'Pain Management for the Adult Population',
      at 24 hours, 48 hours, 72 hours, and PRN with opioid requests in all groups and opioid
      administration follow up within one hour as per IHS inpatient medication administration
      policy. Follow up medication administration scores will not be recorded as part of study
      results.

      Secondary assessments will include the incidence of ileus both during hospitalization,
      increase in aspartate aminotransferase (AST)/ alanine aminotransferase (ALT), post-operative
      tidal volumes as assessed by incentive spirometry as compared to pre- surgical values, time
      from Cardiovascular Intensive Care Unit (CVICU) arrival to extubation in both groups, and the
      effects of an opioid based regimen versus an opioid sparing regimen on cost of medication and
      hospitalization.

      The investigators hypothesize that a scheduled opioid- sparing pain regimen consisting of
      intravenous Acetaminophen IV APAP and PO Gabapentin for 48 hours post- operatively will
      reduce opioid consumption while maintaining adequate pain relief as evidenced by pain scores
      less than two (2), and a reduction in opioid consumption, and that reduced opioid consumption
      will lead to a reduction in the incidence of ileus, an opioid related side effect, no
      increase in AST/ALT, post-operative tidal volumes as assessed by incentive spirometry
      comparable to pre- surgical values, and demonstrate a positive effect on the cost of
      medication and hospitalization.
    

Intervention name(s): Oral Gabapentin and Intravenous Acetaminophen (IV APAP); Opiate based pain regimen.
Intervention type(s): Drug; Drug
Intervention description(s): Scheduled multimodal pain regimen consisting of oral Gabapentin paired with intravenous Acetaminophen following cardiopulmonary bypass surgery.; Standard of care opiate based pain regimen.
Other intervention name(s): PO Gabapentin and IV APAP; Post operative opioids
Intervention MeSH terms: Acetaminophen; Gabapentin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cardiac; surgery; pain