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| Name | Class |
|---|---|
| Ochsner Health System | OTHER |
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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.
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. Finally, there is a growing body of literature 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, randomized, single-blind study, the investigators will evaluate the clinical impact of pharmacogenetics-guided treatment on the duration of the post-surgical hospital stay and on patient well-being as determined by post-op pain assessments. Additionally, the impact of PGx-guided treatment on narcotic consumption, number of adverse events, re-admission rates and costs will be evaluated during the study duration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NeuroIDgenetix Test Panel Intervention | Experimental | The medical provider for the NeuroIDgenetix-guided group will make post-operative pain management recommendations based on test results. Patient outcomes, length of hospital stay and number of medical visits will be measured throughout the study. |
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| Control | No Intervention | The medical provider for the control group will not receive the NeuroIDgenetix Test Panel results and will make post-operative pain management recommendations based as usual. Patient outcomes, length of hospital stay and number of medical visits will be measured throughout the study. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NeuroIDgenetix Test Panel | Genetic | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of length of post-surgical hospital stay between the two treatment arms. | Duration of the post-surgical hospital stay | From date of surgery until hospital discharge, assessed up to 3 months |
| Comparison of patient well being between the two treatment arms as measured by pain scores | Comparison of patient well being between the two treatment arms as measured by pain scores. | 3 months |
| Comparison of patient well being between the two treatment arms as measured by disability scores | Comparison of patient well being between the two treatment arms as measured by disability scores. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of post-operative narcotic consumption between the two treatment arms | Comparison of post-operative narcotic consumption between the two treatment arms | 3 months |
| Comparison of opioid-related adverse effects between the two treatment arms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wale Sulaiman, MD | Ochsner Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ochsner Health System | New Orleans | Louisiana | 70121 | United States |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Comparison of opioid-related adverse effects between the two treatment arms
| 3 months |
| Comparison of time to mobilization between the two treatment arms | Comparison of time to mobilization between the two treatment arms | 3 months |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |