Genomic Opioid Optimization of Dosing and Selections (GOODS) Study

Mayo Clinic

Status: Completed

Conditions: Perioperative/Postoperative Complications

Treatments: Other: Review results; Other: Pharmacogenomic (PGx)

Study type: Interventional

Funder types: Other

Identifiers

NCT03579121

17-006577

Details and patient eligibility

About

The researchers are conducting this study to see if pharmacogenomic testing before surgery helps the doctor to choose which medications will work best for the patient.

Full description

Participants, undergoing total knee replacements, will be randomized into two groups. Both groups will receive pharmacogenomics (PGx) testing preoperatively. The PGx guided group will have their results reviewed by the clinicians during their treatment and the results may guide clinical decisions. The control group results will be sealed until completion of treatment and clinicians will not have access to this information. These participants will undergo standard treatment dosing and medication selection.

Enrollment: 76 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing primary total knee arthroplasty
• Patients must understand and provide written informed consent and HIPAA authorization prior to initiation of any study-specific procedures.

Exclusion criteria

• Patients with a current diagnosis of chronic pain
• Patients requiring narcotics for greater than one week prior to surgery
• Patients with chronic kidney disease with a pre-op creatinine greater than 1.5
• Patient preference or need for spinal anesthesia rather than general anesthesia
• Patient planned for robotic surgical approach

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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76 participants in 2 patient groups

Pharmacogenomic (PGx) guided

Experimental group

Description:

Subjects will have Pharmacogenomic (PGx) testing preoperatively. The pharmacists will review results and make recommendations to the anesthesia and orthopedic teams for perioperative anesthesia and analgesia. The teams will use this information to drive clinical decisions as they see fit.

Treatment:

Other: Pharmacogenomic (PGx)

Other: Review results

Control

Active Comparator group

Description:

Subjects will undergo Pharmacogenomic (PGx) preoperatively but the results will be sealed until completion of treatment and clinicians will not have access to this information. These patients will undergo standard treatment dosing and medication selection.

Treatment:

Other: Pharmacogenomic (PGx)