Using ketamine to reduce pain in patients undergoing aortic repair
A Randomized, Double-blind, Placebo-controlled, Study to Identify the Opioid-sparing Effects, and Pain-reduction Potential of Low Dose Ketamine on Patients Undergoing TEVAR Procedures Receiving NCI
This study is testing if low doses of ketamine can help reduce pain and the need for opioids in patients recovering from aortic repair surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | University of Kentucky Academic / other |
| Locations | 1 site (Lexington, Kentucky) |
| Trial ID | NCT04600089 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effects of low dose, sub-dissociative ketamine on postoperative pain and opioid consumption in patients undergoing thoracic endovascular aortic repair (TEVAR) procedures who are also receiving naloxone continuous infusion (NCI). The research focuses on patients who typically experience high levels of postoperative pain and opioid requirements due to the use of NCI, which is intended to prevent spinal cord ischemia. By administering sub-dissociative doses of ketamine, the study seeks to determine if it can effectively reduce pain and opioid use in the critical 48 hours following surgery.
Who should consider this trial
Good fit: Ideal candidates for this study are patients scheduled for elective thoracic aorta repair or thoracoabdominal aortic repair who require naloxone continuous infusion for spinal prophylaxis.
Not a fit: Patients with allergies to ketamine, acetaminophen, or fentanyl, as well as those with certain psychiatric or neurological conditions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce opioid consumption and improve pain management for patients undergoing aortic repair procedures.
How similar studies have performed: Previous studies have indicated that ketamine can provide effective analgesia and opioid-sparing effects, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * willing to give informed consent * scheduled for elective thoracic aorta repair or thoracoabdominal aortic repair * requires naloxone continuous infusion for spinal prophylaxis Exclusion Criteria: * allergy to ketamine, acetaminophen, or fentanyl * diagnosis of schizophrenia * history of hydrocephalus or central nervous system mass * incarcerated individuals * pregnant or lactating individuals
Where this trial is running
Lexington, Kentucky
- University of Kentucky Medical Center — Lexington, Kentucky, United States (Recruiting)
Study contacts
- Principal investigator: Samuel Tyagi, MD — University of Kentucky
- Study coordinator: Eric Johnson, PharmD
- Email: eric.johnson@uky.edu
- Phone: 8593235722
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.