NCT04625283

The Impact of Perioperative Ketamine Infusion on Surgical Recovery

The Effect and Contribution of a Perioperative Ketamine Infusion in an Established Enhanced Recovery Pathway

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,570 (actual)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Ketamine	Participants in the ketamine arm will receive intraoperative and postoperative ketamine.
DRUG	Placebo	Participants in the placebo arm will receive intraoperative and postoperative saline.

Timeline

• Start date: 2021-04-12
• Primary completion: 2024-01-26
• Completion: 2024-02-01
• First posted: 2020-11-12
• Last updated: 2025-02-04
• Results posted: 2025-02-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study