Genomic Opioid Optimization of Dosing and Selections (GOODS) Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-12

Study Completion Date

2022-04-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Perioperative/Postoperative Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Participants

Participants will not be aware of which arm of the study they are enrolled.

Study Groups

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Pharmacogenomic (PGx) guided

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.

Group Type EXPERIMENTAL

Pharmacogenomic (PGx)

Intervention Type OTHER

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

Review results

Intervention Type OTHER

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

Control

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.

Group Type ACTIVE_COMPARATOR

Pharmacogenomic (PGx)

Intervention Type OTHER

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

Interventions

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Pharmacogenomic (PGx)

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

Intervention Type OTHER

Review results

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No