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Genomic Opioid Optimization of Dosing and Selections (GOODS) Study

Not Applicable
Completed
Conditions
Perioperative/Postoperative Complications
Registration Number
NCT03579121
Lead Sponsor
Mayo Clinic
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
76
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Change in Overall Benefit of Analgesic Score (OBAS)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
NameTimeMethod
Change in prescription pattern for postoperative pain control.baseline, 48 hours following PACU discharge

Overall benefit of change in opioid prescription

Change in Opioid requirementsbaseline, 48 hours following PACU discharge

Opioid doses will be recorded and converted into morphine equivalents.

Changes in opioid use perioperatively based on pharmacogenomic testingbaseline, 48 hours following PACU discharge

Opioid doses will be recorded and converted into morphine equivalents.

Trial Locations

Locations (1)

Mayo Clinic in Arizona

🇺🇸

Phoenix, Arizona, United States

Mayo Clinic in Arizona
🇺🇸Phoenix, Arizona, United States

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