The Impact of Perioperative Ketamine Infusion on Surgical Recovery

Ketamine

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.

Intervention / Treatment

This study will be performed as a pragmatic controlled clinical trial with parallel group assignment. Randomization will be in a cluster format.
  • Ketamine (DRUG)
    Participants in the ketamine arm will receive intraoperative and postoperative ketamine.
  • Placebo (DRUG)
    Participants in the placebo arm will receive intraoperative and postoperative saline.

Condition or Disease

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

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Enrolling by invitation
    Study results: No Results Available
    Enrollment: 1544 (ESTIMATED)
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Apr 12, 2021 ACTUAL
    Primary Completion: Apr 01, 2024 ESTIMATED
    Completion Date: Apr 01, 2024 ESTIMATED
    Study First Posted: Nov 12, 2020 ACTUAL
    Last Updated: Sep 07, 2023

    Sponsors / Collaborators

    Lead Sponsor: Vanderbilt University Medical Center
    Responsible Party: N/A

    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.

    Participant Groups

    • Participants in this arm will receive intraoperative ketamine bolus (0.5mg/kg) followed by continuous infusion 5 mcg/kg/min and also will receive postoperative ketamine infusion (2.5 mcg/kg/min, up to 100kg max) for 48 hours.

    • Participants in this arm will receive an equivalent volume of intraoperative saline bolus followed by continuous saline infusion and also will receive postoperative saline infusion for 48 hours.

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

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

    Secondary Outcomes

    • Inpatient opioid consumption measured in morphine milligram equivalents

    • Incidence of ileus requiring gastric decompression as defined by orogastric or nasogastric tube placement in the postoperative period.

    • Rapid response as a binary outcome

    • Transfer to ICU as a binary outcome

    • Total incidence of side effects (hallucination, sedation, lightheadedness, patient request) as adverse reactions requiring early cessation.

    More Details

    NCT Number: NCT04625283
    Other IDs: 200210
    Study URL: https://clinicaltrials.gov/study/NCT04625283
    Last updated: Sep 29, 2023