Prospective Observational Clinical Study to Evaluate Patient Outcomes Following Pharmacogenetic Testing of Patients Undergoing Elective Surgical Procedures
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|ClinicalTrials.gov Identifier: NCT02605343|
Recruitment Status : Completed
First Posted : November 16, 2015
Last Update Posted : June 6, 2016
|Condition or disease||Intervention/treatment|
|Acute Pain Surgery||Other: NeuroIDgenetix Test Panel|
The incidence of opioid-related adverse drug events can reach as high as 50% in surgical patients and poor pain management is a significant risk factor for early readmission. In addition, the rate of non- response to certain analgesics is double in patients who are poor metabolizers as demonstrated by mutations in both CPY26D alleles. There is a growing body of literature that indicate that ineffective acute pain management contributes significantly to the risk of chronic pain syndromes. Genetics and drug interactions can alter both the pharmacokinetics and pharmacodynamics of a multitude of drug compounds and in turn influence both the safety and efficacy of selected therapeutic regimens.
Pharmacogenetic-guided therapy selection can enhance patient response by facilitating the selection of the most appropriate medication at the most effective dose in the shortest possible time.
In this prospective, observational, single-blind study, the investigators will evaluate the clinical impact of pharmacogenetics-guided treatment on patient well-being as determined by post-op pain assessments and the frequency of changes in analgesics predicted by testing results. Additionally, the impact of PGx-guided treatment on narcotic consumption, time to mobilization, number of adverse events, length of stay, and re-admission rates compared to historical data will be evaluated during the duration of the study.
|Study Type :||Observational|
|Actual Enrollment :||110 participants|
|Observational Model:||Case Control|
|Official Title:||Prospective Observational Clinical Study to Evaluate Patient Outcomes Following Pharmacogenetic Testing of Patients Undergoing Elective Surgical Procedures Compared to Historical Data|
|Study Start Date :||August 2015|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||April 2016|
NeuroIDgenetix-guided Pain Management
The medical provider for the NeuroIDgenetix-guided group will make post-operative pain management recommendations based on test results. Patient outcomes, narcotic consumption, opioid-related adverse effects, time to mobilization, number of adverse drug events and number of hospital and/or medical visits will be measured throughout the study.
Other: NeuroIDgenetix Test Panel
The NeuroIDgenetix Test Panel is used to make recommendations on post-operative pain medication therapy that may be impacted by the genetic background of the patient.
The retrospective chart review will utilize patient outcomes from patients meeting the study inclusion/exclusion criteria. The medical provider for the control group will not have received the NeuroIDgenetix Test Panel results and would have made post-operative pain management recommendations per standard of care.
- Comparison of patient well-being measured by OBAS score between the two study groups. [ Time Frame: From date of surgery until last follow-up visit, assessed at 30 days post-surgery ]Comparison of patient well-being between experimental and control group as measured by Overall Benefit of Analgesics (OBAS) score.
- Comparison of length of post-surgical hospital stay between the two study groups [ Time Frame: From date of surgery until hospital discharge, assessed up to 1 month ]Comparison of duration of post-surgical hospital stay between experimental and control group.
- Comparison of patient well-being measured by BPI score between the two study groups [ Time Frame: From date of surgery until last follow-up visit, assessed at 30 days post-surgery ]Comparison of patient well-being between experimental and control group as measured by Brief Pain Inventory-Short Form score.
- Comparison of post-operative narcotic consumption between the two study groups [ Time Frame: From date of surgery until last follow-up visit, assessed at 30 days post-surgery ]Comparison of post-operative narcotic consumption between the two study groups
- Comparison of time to mobilization between the two study groups [ Time Frame: From date of surgery to mobilization, assessed up to 30 days post-surgery ]Comparison of time to mobilization between the two study groups
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02605343
|United States, Ohio|
|University Hospitals of Cleveland Case Medical Center|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||Anthony J Senagore, MD||University Hospitals Case Medical Centers|