Genomic Opioid Optimization of Dosing and Selections (GOODS) Study

Mayo Clinic76 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

SINGLE

Enrollment

Conditions

Perioperative/Postoperative Complications

Interventions

Pharmacogenomic (PGx)OTHER

Administer a pharmacogenomics test (buccal swab) during the pre-operative setting

Review resultsOTHER

Pharmacogenomic (PGx) results reviewed by the clinicians during their treatment and the results may guide clinical decisions.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic in Arizona

Phoenix, Arizona, United States

Outcomes

Primary Outcomes

Change in Overall Benefit of Analgesic Score (OBAS)

The overall benefit of analgesia score (OBAS) is a daily multi-dimensional survey that assesses analgesia benefits, opioid-related adverse events (ORAEs), and patient satisfaction. It is a seven-item scale, with items ranging from( 0 = not at all) to(4 = very much). To calculate the Total OBAS score, compute the sum of scores in items 1-6 and add '4-score in item 7'. Low score indicates high benefit.

Time frame: baseline, 48 hours following PACU discharge

Secondary Outcomes

Change in prescription pattern for postoperative pain control.

Overall benefit of change in opioid prescription

Time frame: baseline, 48 hours following PACU discharge

Change in Opioid requirements

Opioid doses will be recorded and converted into morphine equivalents.

Time frame: baseline, 48 hours following PACU discharge

Changes in opioid use perioperatively based on pharmacogenomic testing

Opioid doses will be recorded and converted into morphine equivalents.

Time frame: baseline, 48 hours following PACU discharge

Data from ClinicalTrials.gov

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