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

NCT02599870 | Terminated

• 1 other identifier: CLP-0007
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Pain; Surgery

Keywords

PGx; pharmacogenetic testing; IDgenetix; Pain Management; AltheaDx; Post-Operative Pain Management

Outcome Measures

Primary Outcomes (3)

• Comparison of length of post-surgical hospital stay between the two treatment arms.

  Duration of the post-surgical hospital stay

  From date of surgery until hospital discharge, assessed up to 3 months

• Comparison of patient well being between the two treatment arms as measured by pain scores

  Comparison of patient well being between the two treatment arms as measured by pain scores.

  3 months

• Comparison of patient well being between the two treatment arms as measured by disability scores

  Comparison of patient well being between the two treatment arms as measured by disability scores.

  3 months

Secondary Outcomes (3)

• Comparison of post-operative narcotic consumption between the two treatment arms

  3 months

• Comparison of opioid-related adverse effects between the two treatment arms

  3 months

• Comparison of time to mobilization between the two treatment arms

  3 months

Study Arms (2)

NeuroIDgenetix Test Panel Intervention

EXPERIMENTAL

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.

Genetic: NeuroIDgenetix Test Panel

Control

NO INTERVENTION

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.

Interventions

NeuroIDgenetix Test Panel 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.

Also known as: IDgenetix Neuro Test, PGx Testing

NeuroIDgenetix Test Panel Intervention

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• AltheaDx: lead
• Ochsner Health System: collaborator

Study Sites (1)

Ochsner Health System

New Orleans, Louisiana, 70121, United States

Location

MeSH Terms

Conditions

Acute Pain; Agnosia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Wale Sulaiman, MD

  Ochsner Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2015
• First Posted: November 9, 2015
• Study Start: September 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: July 9, 2018

Record last verified: 2018-07

Locations

US (1)