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

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ClinicalTrials.gov Identifier: NCT02711592
Recruitment Status : Recruiting
First Posted : March 17, 2016
Last Update Posted : October 18, 2018
Sponsor:
Information provided by (Responsible Party):
TriHealth Inc.

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.

Condition or disease Intervention/treatment Phase
Arthroplasty, Replacement, Knee Pain, Postoperative Genetic: Genetic Panel for Analgesics Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Utilizing Pharmacogenomics Information in Enhancing Post-operative Total Joint Replacement Pain Management: A Pilot Study
Study Start Date : March 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Pain Scores [ Time Frame: Surgery to 6 weeks postop (+/- 2 weeks) ]
    Numerical patient reported pain scales.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02711592


Contacts
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Contact: Alexandra N Sympson, BA 513-862-1904 alexandra_sympson@trihealth.com
Contact: Pam Plummer, MSN 513-862-6918 pam_plummer@trihealth.com

Locations
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United States, Ohio
Good Samaritan Hospital Recruiting
Cincinnati, Ohio, United States, 45220
Contact: Alex Sympson, BA    513-862-1904    alexandra_sympson@trihealth.com   
Contact: Pam Plummer, MSN    513-862-6918    pam_plummer@trihealth.com   
Principal Investigator: Mark A Snyder, MD         
Sponsors and Collaborators
TriHealth Inc.
Investigators
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Principal Investigator: Mark Snyder, MD TriHealth Inc.

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Responsible Party: TriHealth Inc.
ClinicalTrials.gov Identifier: NCT02711592     History of Changes
Other Study ID Numbers: 15-037
First Posted: March 17, 2016    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by TriHealth Inc.:
Orthopaedic Pain Management
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs