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The Impact of Perioperative Ketamine Infusion on Surgical Recovery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04625283
Recruitment Status : Enrolling by invitation
First Posted : November 12, 2020
Last Update Posted : April 14, 2021
Sponsor:
Information provided by (Responsible Party):
Britany Lynn Raymond, MD, Vanderbilt University Medical Center

Study Description
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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, c) pain scores, and d) surgical outcomes after major abdominal surgery.

Condition or disease Intervention/treatment Phase
Opioid Use Enhanced Recovery After Surgery Anesthesia Ketamine Pain, Postoperative Drug: Ketamine Drug: Placebo Phase 4

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, pain scores, and surgical outcomes. The investigators will begin with studying ketamine.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect and Contribution of a Perioperative Ketamine Infusion in an Established Enhanced Recovery Pathway
Actual Study Start Date : April 12, 2021
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arms and Interventions
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Arm Intervention/treatment
Experimental: Ketamine
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 mg/kg/min, up to 100kg max) for 48 hours.
 Drug: Ketamine
Participants in the ketamine arm will receive intraoperative and postoperative ketamine.
Other Name: Ketalar
Placebo Comparator: Saline
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.
 Drug: Placebo
Participants in the placebo arm will receive intraoperative and postoperative saline.
Other Name: Saline


Outcome Measures
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Primary Outcome Measures :
  1. Hospital Length of Stay [ Time Frame: From hospital admission until discharge, typically 3-5 days ]
    The participants total hospital length of stay measured in days


Secondary Outcome Measures :
  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. Pain scores [ Time Frame: Inpatient baseline day through inpatient day 3 ]
    Numerical pain scores, ranging from 0 to 10 with 0 being no pain and 10 being worse pain possible

  3. Incidence of Surgical Outcomes - Return of bowel function [ Time Frame: From hospital admission until discharge, typically 3-5 days ]
    Return of bowel function measured in hours

  4. Incidence of Surgical Outcomes - Gastrointestinal Complications [ Time Frame: From hospital admission until discharge, typically 3-5 days ]
    Incidence of ileus and/or nausea

  5. Incidence of Surgical Outcomes - Rapid Response [ Time Frame: From hospital admission until discharge, typically 3-5 days ]
    Rapid response as a binary outcome

  6. Incidence of Surgical Outcomes - ICU Transfer [ Time Frame: From hospital admission until discharge, typically 3-5 days ]
    Transfer to ICU as a binary outcome

  7. Incidence of Adverse Side Effects [ Time Frame: From hospital admission until discharge, typically 3-5 days ]
    Total incidence of side effects (hallucination, sedation, lightheadedness, patient request) as adverse reactions requiring early cessation.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 regional nerve block
  • patient refusal
  • direct transfer from operating room to intensive care unit with endotracheal tube placed
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04625283


Locations
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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
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Principal Investigator: Britany L Raymond, MD Vanderbilt University Medical Center
More Information
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Publications:

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Responsible Party: Britany Lynn Raymond, MD, MD, Assistant Professor, Department of Anesthesiology, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT04625283    
Other Study ID Numbers: 200210
First Posted: November 12, 2020    Key Record Dates
Last Update Posted: April 14, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The investigators do not plan to share individual participant data.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Britany Lynn Raymond, MD, Vanderbilt University Medical Center:
ERAS
Enhanced Recovery After Surgery
Ketamine
Opioid
Learning Healthcare System
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action