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Completed

NCT Number: NCT04625283

The Impact of Perioperative Ketamine Infusion on Surgical Recovery

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ketamine

Drug

Participants in the ketamine arm will receive intraoperative and postoperative ketamine.

Other names: Ketalar

Placebo

Drug

Participants in the placebo arm will receive intraoperative and postoperative saline.

Other names: Saline

Primary outcomes

  1. Length of Stay

    Time frame: From surgery start until discharge, typically 3-5 days

    The participants length of stay, from anesthesia beginning to discharge, measured in days

Secondary outcomes

  1. Total Consumption of Inpatient Opioids

    Time frame: From hospital admission until discharge, typically 3-5 days

    Inpatient opioid consumption measured in morphine milligram equivalents

  2. Number of Participants With Ileus

    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.

  3. Number of Participants Who Encounter Rapid Response Team Activation

    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

  4. Number of Participants Who Experienced ICU Transfer

    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

  5. Number of Participants Who Experienced Adverse Side Effects

    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.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Nov 12, 2020
Registry last updated
Feb 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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