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.

Study Timeline

• Study First Submitted: 2018-06-25
• Study First Submitted QC: 2018-06-25
• Study First Posted: 2018-07-06
• Study Start: 2018-10-12
• Primary Completion: 2022-03-01
• Study Completion: 2022-04-01
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-13
• Last Update Posted: 2022-06-15

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

Name	Time	Method
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

Name	Time	Method
Change in prescription pattern for postoperative pain control.	baseline, 48 hours following PACU discharge	Overall benefit of change in opioid prescription
Change in Opioid requirements	baseline, 48 hours following PACU discharge	Opioid doses will be recorded and converted into morphine equivalents.
Changes in opioid use perioperatively based on pharmacogenomic testing	baseline, 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