Clinical trial NCT04625283: The Impact of Perioperative Ketamine Infusion on Surgical Recovery
Official title: The Effect and Contribution of a Perioperative Ketamine Infusion in an Established Enhanced Recovery Pathway
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Opioid Use
Enhanced Recovery After Surgery
Anesthesia
Ketamine
Pain, Postoperative
Keywords: ERAS
Enhanced Recovery After Surgery
Ketamine
Opioid
Learning Healthcare System
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2020-11-12
Enrollment: 1570
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will be performed as a pragmatic controlled clinical trial with parallel group assignment. Randomization will be in a cluster format.
Primary purpose: TREATMENT

Brief 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.

Detailed description: Opioids are powerful analgesic medications that can reduce pain through action at the mu receptor. Unfortunately, activation of the mu receptor also results in undesirable side effects, such as respiratory depression, sedation, bowel ileus, nausea, itching, and tolerance. Therefore, in order to effectively treat pain with the least amount of opioids required, a multi-modal approach must include medications with different mechanisms of actions at alternative receptors. Some examples of non-narcotic pain medications include acetaminophen (Tylenol), anti-inflammatories (NSAIDS), muscle relaxants, local anesthetics, gabapentinoids (Lyrica), and ketamine, to name a few. 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' or enhanced recovery after surgery (ERAS). 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. Ultimately, the investigators aim to perform a series of randomized controlled trials in which we isolate each component of the pathway to investigate its effects on length of stay, total opioid consumption, and surgical outcomes. The investigators will begin with studying ketamine.

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

Primary outcomes:
measure: Length of Stay
timeFrame: From surgery start until discharge, typically 3-5 days
Secondary outcomes:
measure: Total Consumption of Inpatient Opioids
timeFrame: From hospital admission until discharge, typically 3-5 days
measure: Number of Participants With Ileus
timeFrame: From hospital admission until discharge, typically 3-5 days
measure: Number of Participants Who Encounter Rapid Response Team Activation
timeFrame: From hospital admission until discharge, typically 3-5 days
measure: Number of Participants Who Experienced ICU Transfer
timeFrame: From hospital admission until discharge, typically 3-5 days
measure: Number of Participants Who Experienced Adverse Side Effects
timeFrame: From hospital admission until discharge, typically 3-5 days
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Britany L Raymond, MD
role: PRINCIPAL_INVESTIGATOR
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