Ketamine in Patients Undergoing TEVAR Procedures Receiving NCI — 2020Ketamine  

Postoperative Pain Clinical Trial

Official title: 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

Status Recruiting

Clinical Trial Summary

The objective of this study is to identify the opioid-sparing effects, and pain-reduction potential of low dose, sub-dissociative ketamine on patients undergoing thoracic endovascular aortic repair (TEVAR) procedures receiving naloxone continuous infusion (NCI).

Clinical Trial Description

Patients undergoing descending aortic repair often experience post-operative pain, and have high post operative opioid requirements. That pain is partially due to the use of naloxone continuous infusion (NCI). NCI is part of a bundled approach used in the first 48 hours post-operatively to prevent spinal cord ischemia, a devastating complication associated with surgical repair of the descending aortic. Data indicate that patients receiving NCI experience elevated post-operative pain scores and increased opioid requirements during the 48-hr post-operative NCI administration, compared to patients not receiving NCI.

Ketamine is an FDA-approved N-methyl D-aspartate (NMDA) antagonist that has been shown to provide adjunctive analgesia and opioid-sparing effects in post-operative surgical patients. At low doses, ketamine provides analgesic benefit without the anesthetic effects seen at higher doses. These doses are commonly referred to sub-dissociative. This study will evaluate whether use of sub dissociative ketamine (SDK) in patients undergoing aortic procedures with the use of NCI will lead to decreased post-operative opioid consumption, and produce improved pain scores in the first 48 hours. ;

Related Conditions & MeSH terms

• Aortic Aneurysm
• Aortic Aneurysm, Thoracoabdominal
• Aortic Dissection
• Descending Aortic Dissection
• Postoperative Pain
• Thoracoabdominal Aortic Aneurysm

• NCT number: NCT04600089
• Study type: Interventional
• Source: University of Kentucky
• Contact: Eric Johnson, PharmD
• Phone: 8593235722
• Email: eric.johnson@uky.edu
• Status: Recruiting
• Phase: Phase 2
• Start date: December 8, 2020
• Completion date: August 2024