Pharmacogenomics Information in Enhancing Post-operative Total Joint Replacement Pain Management: a Pilot Study

Utilizing Pharmacogenomics Information in Enhancing Post-operative Total Joint Replacement Pain Management: A Pilot Study

The objective of this study is to see how pain management and its outcomes are effected when pharmacogenomic testing is used to determine patient specific pain medication and dosing. Our goal is to determine if through the use of analgesic genetic testing, TKA post-operative patients will see a decrease in narcotic consumption, postsurgical opioid- related adverse reactions, and length of stay, overall NRS pain scores and while maintaining or improving their satisfaction scores.

Study Overview

• Status: Terminated
• Conditions: Pain, Postoperative; Arthroplasty, Replacement, Knee
• Intervention / Treatment: Genetic: Genetic Panel for Analgesics

Detailed Description

This is a pilot study that will look at how pain management will be effected when pharmacogenomic testing is utilized to select and dose narcotic pain medications prescribed for breakthrough pain in post-operative total knee arthroplasty (TKA) patients. Patients will receive individualized analgesics and doses for pain mitigation based on genetic testing results. Post op pain scores, narcotic consumption, adverse reactions, length of stay and patient satisfaction with pain management will be collected and analyzed to determine the significance of the pharmacogenomic analgesic testing.

Due to the lack of literature and evidence surrounding pharmacogenomics and its use in selecting analgesics to control post-operative pain a pilot study is being conducted to evaluate effect size (statistical variability) in an attempt to predict an appropriate sample size for a larger scale randomized control trial. The subjects enrolled and data collected for this internal pilot will be used in the larger scale parent study as well.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45220
      • Good Samaritan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Patients undergoing total knee arthroplasty Patients able to understand study intent, and agree to study participation. Patients with a history of preoperative narcotic dependence and/or, adverse reactions to narcotics, and/or have experienced ineffective pain management with narcotics.

Exclusion Criteria:

Patients with orthopaedic and medical co-morbidities that would thwart postoperative pain control such as extra-articular pathology with referred pain to the knee (spinal stenosis, neuropathy,ipsilateral hip disease), severe knee deformity, post-traumatic and inflammatory arthritis Patients with chronic pain disorders BMI > 40 ASA class > III GI bleed within 6 months of surgery History of drug or alcohol abuse Patients unable to receive multimodal pain remitting agents including Celecoxib and Pregabalin.

Patients with diabetes and patients who are unable to receive decadron Any patient receiving general anesthesia Patients who will need to go to an ECF upon discharge Patients who are pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Genetic Panel for Analgesics; Genetic testing for analgesics prior to surgery will be conducted. The subject will receive postoperative analgesia based on test results.	Genetic: Genetic Panel for Analgesics; All patients will receive genetic test panel to determine individualized optimal pain management following Total Knee Arthroplasty.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Scores	Numerical patient reported pain scales.	Surgery to 6 weeks postop (+/- 2 weeks)

Collaborators and Investigators

• Sponsor: TriHealth Inc.
• Investigators: Principal Investigator: Mark Snyder, MD, TriHealth Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2016
• Primary Completion (Actual): August 22, 2019
• Study Completion (Actual): August 22, 2019

Study Registration Dates

• First Submitted: March 13, 2016
• First Submitted That Met QC Criteria: March 13, 2016
• First Posted (Estimate): March 17, 2016

Study Record Updates

• Last Update Posted (Actual): February 25, 2021
• Last Update Submitted That Met QC Criteria: February 24, 2021
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Orthopaedic Pain Management
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Analgesics
• Other Study ID Numbers: 15-037

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO