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NCT03679013 · ClinicalTrials.gov registry record · Phase 2
Effectiveness of an Opioid Sparing Pain Regimen in Cardiac Surgery
A Phase 2 study, sponsored by Inova Health Care Services.
- Completed
- Registry status
- Phase 2
- Development phase
- 19
- Enrollment target
NCT03679013 is a Phase 2 study that has completed, run by Inova Health Care Services. The registered enrollment target is 19 participants.
The verdict
NCT03679013, a Phase 2 study, has completed, sponsored by Inova Health Care Services.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 19 participants
- Enrollment target
Study 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.
Interventions
- DRUG Oral Gabapentin and Intravenous Acetaminophen (IV APAP)
- DRUG Opiate based pain regimen.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2019-04-19 |
| Est. Completion | 2019-07-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03679013
The ClinicalTrials.gov registry entry for NCT03679013 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Inova Health Care Services, which has 75 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Oral Gabapentin and Intravenous Acetaminophen (IV APAP) is the first listed.
NCT03679013 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03679013 about?
NCT03679013 is a clinical study titled "Effectiveness of an Opioid Sparing Pain Regimen in Cardiac Surgery". 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 comp...
What is the current status of trial NCT03679013?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 19 participants. The study started on 2019-04-19. Estimated completion is 2019-07-12.
What interventions are being tested in trial NCT03679013?
The interventions under investigation include: Oral Gabapentin and Intravenous Acetaminophen (IV APAP) (DRUG), Opiate based pain regimen. (DRUG).
Who is sponsoring clinical trial NCT03679013?
This trial is sponsored by Inova Health Care Services, which has 75 total clinical trials registered on ClinicalTrials.gov.
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