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Genomic Opioid Optimization of Dosing and Selections (GOODS) Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03579121
Recruitment Status : Recruiting
First Posted : July 6, 2018
Last Update Posted : January 12, 2022
Sponsor:
Information provided by (Responsible Party):
Molly B. Kraus, Mayo Clinic

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Perioperative/Postoperative Complications Other: Pharmacogenomic (PGx) Other: Review results Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: All subjects meeting inclusion/exclusion criteria will undergo pharmacogenomic testing. A pharmacist will review the pharmacogemic report and make recommendations for patients in the interventional group. The anesthesiologist and orthopedic surgeon will use that information for preoperative clinical decisions related to anesthesia and analgesia.
Masking: Single (Participant)
Masking Description: Participants will not be aware of which arm of the study they are enrolled.
Primary Purpose: Screening
Official Title: Genomic Opioid Optimization of Dosing and Selections (GOODS) Study
Actual Study Start Date : October 12, 2018
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : May 2, 2022
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Change in Overall Benefit of Analgesic Score (OBAS) [ Time Frame: baseline, 48 hours following PACU discharge ]
    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.


Secondary Outcome Measures :
  1. Change in prescription pattern for postoperative pain control. [ Time Frame: baseline, 48 hours following PACU discharge ]
    Overall benefit of change in opioid prescription

  2. Change in Opioid requirements [ Time Frame: baseline, 48 hours following PACU discharge ]
    Opioid doses will be recorded and converted into morphine equivalents.

  3. Changes in opioid use perioperatively based on pharmacogenomic testing [ Time Frame: baseline, 48 hours following PACU discharge ]
    Opioid doses will be recorded and converted into morphine equivalents.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03579121


Contacts
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Contact: Carrie King 480-342-6236 King.Carrie1@mayo.edu

Locations
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United States, Arizona
Mayo Clinic in Arizona Recruiting
Phoenix, Arizona, United States, 85054
Contact: Carrie King    480-342-6236    King.Carrie1@mayo.edu   
Principal Investigator: Molly Kraus, MD         
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Molly B Kraus Mayo Clinic
More Information
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Additional Information:

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Responsible Party: Molly B. Kraus, Assistant Professor of Anesthesiology, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03579121    
Other Study ID Numbers: 17-006577
First Posted: July 6, 2018    Key Record Dates
Last Update Posted: January 12, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Molly B. Kraus, Mayo Clinic:
pharmacogenomics
preoperative evaluation
perioperative opioid use
Additional relevant MeSH terms:
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Postoperative Complications
Pathologic Processes