Clinical Study to Evaluate Clinical Impact of PGx-Guided Treatment for Patients Undergoing Elective Spinal Surgical Procedures
Stopped early · Not applicable
Conditions studied: Acute Pain, Surgery
In brief
The purpose of this study is to evaluate the effect of pharmacogenetic (PGx) guided treatment when implemented into the pre-operative process for patients undergoing an elective spinal surgical procedure and requiring post-operative acute pain management, as compared to a group of subjects with the same attributes without the guidance of PGx testing for their post-surgery pain management. This study will also evaluate whether PGx testing can reduce narcotic consumption, opioid-related adverse effects, time to mobilization, medical visits and costs.
Key facts
- Study ID
- NCT02599870
- Run by
- AltheaDx
- People needed
- 56
- Starts
- 2015-09-01
- Expected to finish
- 2016-02-01
- Last updated by the study team
- 2018-07-09
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female subjects over the age of 18;
- Patients undergoing an elective spine surgical procedures
- Willing and able to comply with study procedures
- Able to provide written informed consent
- Surgery timing - scheduled to occur after PGx testing and IDgenetix test report review (at least 4 days after Pre-Op visit)
You may not qualify if…
- Unwilling or unable to provide written informed consent and to comply with study procedures
- Any subject for whom providing a buccal swab sample would be contraindicated or not possible
- Subject with a history of chronic renal dysfunction, Chronic Kidney Disease (Stage 4 or 5)
- abnormal hepatic function within the last 2 years (INR >1.2 not attributable to anticoagulant medications, AST/aspartate aminotransferase or ALT/alanine aminotransferase >1.5x normal, or suspected cirrhosis)
- a history of malabsorption (short gut syndrome)
- any gastric or small bowel surgery less than 3 months prior to study enrollment
- Patients with a significant unstable medical condition or life threatening disease
- History of prior pharmacogenetic testing
Where it is running
- Ochsner Health System — New Orleans, Louisiana, United States
Full record on ClinicalTrials.gov
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