Genomic Opioid Optimization of Dosing and Selections (GOODS) Study

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.

Study Overview

• Status: Completed
• Conditions: Perioperative/Postoperative Complications
• Intervention / Treatment: Other: Pharmacogenomic (PGx); Other: Review results

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic in Arizona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pharmacogenomic (PGx) guided; 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.	Other: Pharmacogenomic (PGx); Administer a pharmacogenomics test (buccal swab) during the pre-operative setting; Other: Review results; Pharmacogenomic (PGx) results reviewed by the clinicians during their treatment and the results may guide clinical decisions.
Active Comparator: Control; 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.	Other: Pharmacogenomic (PGx); Administer a pharmacogenomics test (buccal swab) during the pre-operative setting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline, 48 hours following PACU discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in prescription pattern for postoperative pain control.	Overall benefit of change in opioid prescription	baseline, 48 hours following PACU discharge
Change in Opioid requirements	Opioid doses will be recorded and converted into morphine equivalents.	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.	baseline, 48 hours following PACU discharge

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Molly B Kraus, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2018
• Primary Completion (Actual): March 1, 2022
• Study Completion (Actual): April 1, 2022

Study Registration Dates

• First Submitted: June 25, 2018
• First Submitted That Met QC Criteria: June 25, 2018
• First Posted (Actual): July 6, 2018

Study Record Updates

• Last Update Posted (Actual): June 15, 2022
• Last Update Submitted That Met QC Criteria: June 13, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: pharmacogenomics; preoperative evaluation; perioperative opioid use
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: 17-006577

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No