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OpenTrials
Completed

NCT Number: NCT03579121

Genomic Opioid Optimization of Dosing and Selections (GOODS) Study

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.

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Key information

Conditions

Perioperative/Postoperative Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Arizona

Phoenix, Arizona, 85054, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pharmacogenomic (PGx)

Other

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

Review results

Other

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

Primary outcomes

  1. 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

  1. Change in prescription pattern for postoperative pain control.

    Time frame: baseline, 48 hours following PACU discharge

    Overall benefit of change in opioid prescription

  2. Change in Opioid requirements

    Time frame: baseline, 48 hours following PACU discharge

    Opioid doses will be recorded and converted into morphine equivalents.

  3. Changes in opioid use perioperatively based on pharmacogenomic testing

    Time frame: baseline, 48 hours following PACU discharge

    Opioid doses will be recorded and converted into morphine equivalents.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jul 6, 2018
Registry last updated
Jun 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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