Surgery Clinical Trial
Official title:
Prospective Observational Clinical Study to Evaluate Patient Outcomes Following Pharmacogenetic Testing of Patients Undergoing Elective Surgical Procedures Compared to Historical Data
The purpose of this study is to evaluate the effect of pharmacogenetics (PGx) guided treatment when implemented into the pre-operative process for patients undergoing bowel surgery, major urologic procedure, or major ventral hernia repair and requiring post-operative acute pain management in an inpatient basis, as compared to a group of subjects with the same attributes without the guidance of PGx testing (historical control group). This study will also evaluate the frequency with which the standard analgesic care plan is adjusted by test results.
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.
;
Observational Model: Case Control, Time Perspective: Prospective
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