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Phase 4 N=1,570 Randomized Quadruple-blind Treatment

The Impact of Perioperative Ketamine Infusion on Surgical Recovery

Opioid Use · Enhanced Recovery After Surgery · Anesthesia · Ketamine · Pain, Postoperative

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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