What side effects are associated with this type of intervention?

Common treatments for postoperative pain include opioids, NSAIDs, acetaminophen, and adjuvant analgesics like gabapentinoids. Opioids can cause sedation, respiratory depression, constipation, and potential for addiction. NSAIDs may lead to gastrointestinal bleeding, renal impairment, and cardiovascular issues. Acetaminophen is generally well-tolerated but can cause liver toxicity at high doses. Gabapentinoids can cause dizziness, sedation, and peripheral edema. Ketamine, an NMDA receptor antagonist, can cause dissociation, hallucinations, increased blood pressure, and nausea.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of postoperative pain, including NMDA receptor antagonists like ketamine. Ketamine is commonly used both intraoperatively and postoperatively for its analgesic and opioid-sparing effects. Other related drugs include gabapentinoids (gabapentin and pregabalin), which are often used as adjuncts to opioids to manage postoperative pain and prevent chronic pain syndromes. Additionally, acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs) are frequently used in multimodal analgesia regimens to reduce opioid consumption and enhance pain control.

What other types of research exist?

Promising alternatives to ketamine for postoperative pain management include: 1) Dexmedetomidine, which has shown effective sedoanalgesic properties and can be combined with other agents like ketorolac for enhanced pain control. 2) Clonidine, particularly when used in combination with other agents such as low-dose ketamine or bupivacaine, has been shown to reduce postoperative morphine consumption. 3) Combinations of bupivacaine, fentanyl, and clonidine have also been optimized for effective postoperative analgesia.

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Ketamine for Aortic Aneurysm Pain Management (2020Ketamine Trial)

Phase 2

Recruiting

Led By Samuel Tyagi, MD

Research Sponsored by Sam Tyagi

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Scheduled for elective thoracic aorta repair or thoracoabdominal aortic repair

Requires naloxone continuous infusion for spinal prophylaxis

Must not have

Diagnosis of schizophrenia

History of hydrocephalus or central nervous system mass

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 hours

Summary

This trial is testing low doses of ketamine to see if it can reduce pain and the need for opioids in patients having a specific type of heart surgery. These patients usually need a lot of pain relief because they are also getting another treatment to prevent a serious complication. Ketamine works by blocking pain signals in the brain. Ketamine is an old anesthetic agent that has been explored for pain relief in various conditions, including cancer pain and acute pain episodes.

Who is the study for?

This trial is for individuals scheduled for elective repair of the thoracic or thoracoabdominal aorta who need naloxone infusion for spinal protection. It's not open to those allergic to ketamine, acetaminophen, or fentanyl; diagnosed with schizophrenia; with hydrocephalus or CNS mass; incarcerated persons; or pregnant/lactating individuals.

What is being tested?

The study aims to see if low-dose ketamine can reduce pain and lessen opioid use in patients having TEVAR procedures while on naloxone infusion. Participants will receive either saline (a placebo) or ketamine alongside standard care.

What are the potential side effects?

Ketamine may cause side effects such as feelings of disconnection from reality at higher doses, but this study uses a lower dose which might result in milder symptoms like dizziness, nausea, or blurred vision.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for surgery on the main artery in my chest or belly.

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I need a continuous naloxone infusion for spinal protection.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have been diagnosed with schizophrenia.

Select...

I have had hydrocephalus or a brain tumor.

Select...

I am allergic to ketamine, acetaminophen, or fentanyl.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cumulative Opioid Dose

Secondary study objectives

Change in Pain

Number of Patients with Ketamine-Induced Delirium

Number of Patients with Uncontrolled Hypertension

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Sub-Dissociative KetamineExperimental Treatment1 Intervention

Participants in this group will receive standard of care as well as a continuous ketamine infusion at the induction of anesthesia and for 48 hours postoperatively.

Group II: Standard of CarePlacebo Group1 Intervention

Participants in this group will receive standard of care as well as a saline infusion during the study period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ketamine

2011

Completed Phase 4

~1120

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Postoperative pain is commonly managed using a multimodal approach that includes medications like ketamine, which is an NMDA receptor antagonist. Ketamine works by blocking NMDA receptors in the central nervous system, which are involved in pain transmission and sensitization. This helps reduce pain and can also have opioid-sparing effects, making it particularly useful for patients who are opioid-tolerant or at risk of opioid-related side effects. Other treatments include intravenous lidocaine, which stabilizes neuronal membranes and reduces pain signaling, and acetaminophen, which inhibits prostaglandin synthesis to reduce pain and inflammation. These mechanisms are crucial for postoperative pain patients as they provide effective pain relief while minimizing the risk of opioid dependence and other adverse effects.

Pathophysiologic Approach to Pain Therapy for Complex Pain Entities: A Narrative Review.