Back to resultsGenomic Opioid Optimization of Dosing and Selections (GOODS) Study
Primary Purpose
Perioperative/Postoperative Complications
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pharmacogenomic (PGx)
Review results
Sponsored by
About this trial
This is an interventional screening trial for Perioperative/Postoperative Complications focused on measuring pharmacogenomics, preoperative evaluation, perioperative opioid use
Eligibility 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
Sites / Locations
- Mayo Clinic in Arizona
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Pharmacogenomic (PGx) guided
Control
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in prescription pattern for postoperative pain control.
Overall benefit of change in opioid prescription
Change in Opioid requirements
Opioid doses will be recorded and converted into morphine equivalents.
Changes in opioid use perioperatively based on pharmacogenomic testing
Opioid doses will be recorded and converted into morphine equivalents.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03579121
Brief Title
Genomic Opioid Optimization of Dosing and Selections (GOODS) Study
Official Title
Genomic Opioid Optimization of Dosing and Selections (GOODS) Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
October 12, 2018 (Actual)
Primary Completion Date
March 1, 2022 (Actual)
Study Completion Date
April 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perioperative/Postoperative Complications
Keywords
pharmacogenomics, preoperative evaluation, perioperative opioid use
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Masking Description
Participants will not be aware of which arm of the study they are enrolled.
Allocation
Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pharmacogenomic (PGx) guided
Arm Type
Experimental
Arm 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.
Arm Title
Control
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Pharmacogenomic (PGx)
Intervention Description
Administer a pharmacogenomics test (buccal swab) during the pre-operative setting
Intervention Type
Other
Intervention Name(s)
Review results
Intervention Description
Pharmacogenomic (PGx) results reviewed by the clinicians during their treatment and the results may guide clinical decisions.
Primary Outcome Measure Information:
Title
Change in Overall Benefit of Analgesic Score (OBAS)
Description
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 Outcome Measure Information:
Title
Change in prescription pattern for postoperative pain control.
Description
Overall benefit of change in opioid prescription
Time Frame
baseline, 48 hours following PACU discharge
Title
Change in Opioid requirements
Description
Opioid doses will be recorded and converted into morphine equivalents.
Time Frame
baseline, 48 hours following PACU discharge
Title
Changes in opioid use perioperatively based on pharmacogenomic testing
Description
Opioid doses will be recorded and converted into morphine equivalents.
Time Frame
baseline, 48 hours following PACU discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Molly B Kraus
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Genomic Opioid Optimization of Dosing and Selections (GOODS) Study
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