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

NCT02711592 | Terminated

• 1 other identifier: 15-037
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Arthroplasty, Replacement, Knee; Pain, Postoperative

Keywords

Orthopaedic Pain Management

Outcome Measures

Primary Outcomes (1)

• Pain Scores

  Numerical patient reported pain scales.

  Surgery to 6 weeks postop (+/- 2 weeks)

Study Arms (1)

Genetic Panel for Analgesics

OTHER

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

Interventions

Genetic Panel for Analgesics GENETIC

All patients will receive genetic test panel to determine individualized optimal pain management following Total Knee Arthroplasty.

Genetic Panel for Analgesics

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• TriHealth Inc.: lead

Study Sites (1)

Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Analgesics

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Mark Snyder, MD

  TriHealth Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2016
• First Posted: March 17, 2016
• Study Start: October 5, 2016
• Primary Completion: August 22, 2019
• Study Completion: August 22, 2019
• Last Updated: February 25, 2021

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)