Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
NCT Number: NCT04625283
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Nashville, Tennessee, 37232, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants in the ketamine arm will receive intraoperative and postoperative ketamine.
Other names: Ketalar
Participants in the placebo arm will receive intraoperative and postoperative saline.
Other names: Saline
Time frame: From surgery start until discharge, typically 3-5 days
The participants length of stay, from anesthesia beginning to discharge, measured in days
Time frame: From hospital admission until discharge, typically 3-5 days
Inpatient opioid consumption measured in morphine milligram equivalents
Time frame: From hospital admission until discharge, typically 3-5 days
Number of participants reporting ileus requiring gastric decompression as defined by orogastric or nasogastric tube placement in the postoperative period.
Time frame: From hospital admission until discharge, typically 3-5 days
Number of participants who encounter rapid response team activation within 72 hours post-operation. This is as a binary outcome
Time frame: From hospital admission until discharge, typically 3-5 days
Number of participants who experienced transfer to ICU. This is as a binary outcome
Time frame: From hospital admission until discharge, typically 3-5 days
Total number of side effects (hallucination, sedation, lightheadedness, patient request) as adverse reactions requiring early cessation.
Vanderbilt University Medical Center
Other
The Effect and Contribution of a Perioperative Ketamine Infusion in an Established Enhanced Recovery Pathway
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