Genomic Opioid Optimization of Dosing and Selections (GOODS) Study

Perioperative/Postoperative Complications Clinical Trial

Official title:

Genomic Opioid Optimization of Dosing and Selections (GOODS) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03579121
• Other study ID #: 17-006577
• Status: Completed
• Phase: N/A
• Start date: October 12, 2018
• Est. completion date: April 1, 2022

Study information

• Verified date: June 2022
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: April 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Perioperative/Postoperative Complications
• Postoperative Complications

Intervention

Other:
• Pharmacogenomic (PGx)
Administer a pharmacogenomics test (buccal swab) during the pre-operative setting
• Review results
Pharmacogenomic (PGx) results reviewed by the clinicians during their treatment and the results may guide clinical decisions.

Locations

Country	Name	City	State
United States	Mayo Clinic in Arizona	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   Mayo Clinic Clinical Trials