Genomic Opioid Optimization of Dosing and Selections (GOODS) Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Perioperative/Postoperative Complications
- Sponsor
- Mayo Clinic
- Enrollment
- 76
- Locations
- 1
- Primary Endpoint
- Change in Overall Benefit of Analgesic Score (OBAS)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Molly B. Kraus
Assistant Professor of Anesthesiology
Mayo Clinic
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
Outcomes
Primary Outcomes
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 Outcomes
- Change in prescription pattern for postoperative pain control.(baseline, 48 hours following PACU discharge)
- Change in Opioid requirements(baseline, 48 hours following PACU discharge)
- Changes in opioid use perioperatively based on pharmacogenomic testing(baseline, 48 hours following PACU discharge)