Phase 4
N=1,570
The Impact of Perioperative Ketamine Infusion on Surgical Recovery
Opioid Use · Enhanced Recovery After Surgery · Anesthesia · Ketamine · Pain, Postoperative
Bottom Line
View on ClinicalTrials.gov: NCT04625283 ↗Enrolled (actual)
1,570
Serious AEs
0.1%
Results posted
Feb 2025
Primary outcome: Primary: Length of Stay — 5.0; 5.0 days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ketamine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Length of Stay |
5.0; 5.0 | — |
| SECONDARY Total Consumption of Inpatient Opioids |
82.5; 90.0 | — |
| SECONDARY Number of Participants With Ileus |
71; 37 | — |
| SECONDARY Number of Participants Who Encounter Rapid Response Team Activation |
39; 26 | — |
| SECONDARY Number of Participants Who Experienced ICU Transfer |
44; 22 | — |
| SECONDARY Number of Participants Who Experienced Adverse Side Effects |
96; 130; 83; 39; 19; 7 | — |
Summary
In order to effectively treat surgical pain with the least amount of opioids required, a multi-modal approach must include medications with different mechanisms of actions at alternative receptors. In light of the opioid epidemic, medical providers at Vanderbilt University Medical Center (VUMC) are strategically combining these medications in a bundled pain-regimen after surgery. These regimens have been shown to decrease opioid consumption, improve surgical outcomes, and reduce hospital stays, thus coining the term 'enhanced recovery pathway'. The combination of these medications has an indisputable synergistic effect. However, it is unknown how each medication contributes individually to the overall efficacy of the pathway. This study will examine the effects of ketamine, within the constructs of a multimodal pain regimen, on a) length of stay, b) opioid consumption, and c) surgical outcomes after major abdominal surgery.
Eligibility Criteria
Inclusion Criteria
- 18 years old or greater
- presenting at VUMC for abdominal surgery on the colorectal, ventral hernia or surgical oncology services on a weekday.
Exclusion Criteria
- allergy or contraindication to ketamine
- unable or refuse to receive a neuraxial or regional nerve block
- patient refusal
- direct transfer from operating room to intensive care unit with endotracheal tube placed
- treating team elects to exclude the patient prior to study drug administration
- abortion of planned surgical procedure
Data sourced from ClinicalTrials.gov (NCT04625283). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.