The Impact of Perioperative Ketamine Infusion on Surgical Recovery

Phase 4

Completed

Conditions: Ketamine
Pain, Postoperative
Anesthesia
Opioid Use
Enhanced Recovery After Surgery

Interventions: Drug: Ketamine
Drug: Placebo

Registration Number: NCT04625283

Lead Sponsor: Vanderbilt University Medical Center

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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1570

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketamine	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 mcg/kg/min, up to 100kg max) for 48 hours.
Saline	Placebo	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.

Primary Outcome Measures

Name	Time	Method
Length of Stay	From surgery start until discharge, typically 3-5 days	The participants length of stay, from anesthesia beginning to discharge, measured in days

Secondary Outcome Measures

Name	Time	Method
Total Consumption of Inpatient Opioids	From hospital admission until discharge, typically 3-5 days	Inpatient opioid consumption measured in morphine milligram equivalents
Number of Participants With Ileus	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.
Number of Participants Who Encounter Rapid Response Team Activation	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
Number of Participants Who Experienced ICU Transfer	From hospital admission until discharge, typically 3-5 days	Number of participants who experienced transfer to ICU. This is as a binary outcome
Number of Participants Who Experienced Adverse Side Effects	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.