Clinical Study to Evaluate Clinical Impact of PGx-Guided Treatment for Patients Undergoing Elective Spinal Surgical Procedures

NCT ID: NCT02599870

Last Updated: 2018-07-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2016-02-29

Brief Summary

The purpose of this study is to evaluate the effect of pharmacogenetic (PGx) guided treatment when implemented into the pre-operative process for patients undergoing an elective spinal surgical procedure and requiring post-operative acute pain management, as compared to a group of subjects with the same attributes without the guidance of PGx testing for their post-surgery pain management. This study will also evaluate whether PGx testing can reduce narcotic consumption, opioid-related adverse effects, time to mobilization, medical visits and costs.

Detailed Description

The incidence of opioid related adverse drug events can reach as high as 50% in surgical patients and poor pain management is a significant risk factor for early readmission. In addition, the rate of non- response to certain analgesics is double in patients who are poor metabolizers as demonstrated by mutations in both CPY26d alleles. Finally, there is a growing body of literature that ineffective acute pain management contributes significantly to the risk of chronic pain syndromes. Genetics and drug interactions can alter both the pharmacokinetics and pharmacodynamics of a multitude of drug compounds and in turn influence both the safety and efficacy of selected therapeutic regimens.

Pharmacogenetic-guided therapy selection can enhance patient response by facilitating the selection of the most appropriate medication at the most effective dose in the shortest possible time.

In this prospective, randomized, single-blind study, the investigators will evaluate the clinical impact of pharmacogenetics-guided treatment on the duration of the post-surgical hospital stay and on patient well-being as determined by post-op pain assessments. Additionally, the impact of PGx-guided treatment on narcotic consumption, number of adverse events, re-admission rates and costs will be evaluated during the study duration.

Conditions

Acute Pain; Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

NeuroIDgenetix Test Panel Intervention

The medical provider for the NeuroIDgenetix-guided group will make post-operative pain management recommendations based on test results. Patient outcomes, length of hospital stay and number of medical visits will be measured throughout the study.

Group Type: EXPERIMENTAL

NeuroIDgenetix Test Panel

Intervention Type: GENETIC

The NeuroIDgenetix Test Panel is used to make recommendations on post-operative pain medication therapy that may be impacted by the genetic background of the patient.

Control

The medical provider for the control group will not receive the NeuroIDgenetix Test Panel results and will make post-operative pain management recommendations based as usual. Patient outcomes, length of hospital stay and number of medical visits will be measured throughout the study.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

NeuroIDgenetix Test Panel

The NeuroIDgenetix Test Panel is used to make recommendations on post-operative pain medication therapy that may be impacted by the genetic background of the patient.

Intervention Type: GENETIC

Other Intervention Names

IDgenetix Neuro Test; PGx Testing

Eligibility Criteria

Inclusion Criteria

• Male or female subjects over the age of 18;
• Patients undergoing an elective spine surgical procedures
• Willing and able to comply with study procedures
• Able to provide written informed consent
• Surgery timing - scheduled to occur after PGx testing and IDgenetix test report review (at least 4 days after Pre-Op visit)

Exclusion Criteria

• Unwilling or unable to provide written informed consent and to comply with study procedures
• Any subject for whom providing a buccal swab sample would be contraindicated or not possible
• Subject with a history of chronic renal dysfunction, Chronic Kidney Disease (Stage 4 or 5)
• abnormal hepatic function within the last 2 years (INR >1.2 not attributable to anticoagulant medications, AST/aspartate aminotransferase or ALT/alanine aminotransferase >1.5x normal, or suspected cirrhosis)
• a history of malabsorption (short gut syndrome)
• any gastric or small bowel surgery less than 3 months prior to study enrollment
• Patients with a significant unstable medical condition or life threatening disease
• History of prior pharmacogenetic testing

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ochsner Health System

OTHER

Sponsor Role: collaborator

AltheaDx

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wale Sulaiman, MD

Role: PRINCIPAL_INVESTIGATOR

Ochsner Health System

Locations

Ochsner Health System

New Orleans, Louisiana, United States

Countries

United States

Other Identifiers

CLP-0007

Identifier Type: -

Identifier Source: org_study_id