Genomic Opioid Optimization of Dosing and Selections (GOODS) Study

NCT03579121 | Completed

• 1 other identifier: 17-006577
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Perioperative/Postoperative Complications

Keywords

pharmacogenomics; preoperative evaluation; perioperative opioid use

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

Pharmacogenomic (PGx) guided

EXPERIMENTAL

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.

Other: Pharmacogenomic (PGx); Other: Review results

Control

ACTIVE COMPARATOR

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.

Other: Pharmacogenomic (PGx)

Interventions

Pharmacogenomic (PGx) OTHER

Administer a pharmacogenomics test (buccal swab) during the pre-operative setting

Control; Pharmacogenomic (PGx) guided

Review results OTHER

Pharmacogenomic (PGx) results reviewed by the clinicians during their treatment and the results may guide clinical decisions.

Pharmacogenomic (PGx) guided

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Arizona

Phoenix, Arizona, 85054, United States

Location

Related Publications (1)

• Kraus MB, Bingham JS, Kekic A, Erickson C, Grilli CB, Seamans DP, Upjohn DP, Hentz JG, Clarke HD, Spangehl MJ. Does Preoperative Pharmacogenomic Testing of Patients Undergoing TKA Improve Postoperative Pain? A Randomized Trial. Clin Orthop Relat Res. 2024 Feb 1;482(2):291-300. doi: 10.1097/CORR.0000000000002767. Epub 2023 Aug 18.

  PMID: 37594401 DERIVED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Postoperative Complications

Interventions

Pharmacogenomic Testing

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Genetic Testing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Study Officials

• Molly B Kraus

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not be aware of which arm of the study they are enrolled.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology

Model Details: 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.

Study Record Dates

• First Submitted: June 25, 2018
• First Posted: July 6, 2018
• Study Start: October 12, 2018
• Primary Completion: March 1, 2022
• Study Completion: April 1, 2022
• Last Updated: June 15, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)