Back to resultsPharmacogenomics Information in Enhancing Post-operative Total Joint Replacement Pain Management: a Pilot Study
Primary Purpose
Arthroplasty, Replacement, Knee, Pain, Postoperative
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Genetic Panel for Analgesics
Sponsored by
About this trial
This is an interventional treatment trial for Arthroplasty, Replacement, Knee focused on measuring Orthopaedic Pain Management
Eligibility 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
Sites / Locations
- Good Samaritan Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Genetic Panel for Analgesics
Arm Description
Genetic testing for analgesics prior to surgery will be conducted. The subject will receive postoperative analgesia based on test results.
Outcomes
Primary Outcome Measures
Pain Scores
Numerical patient reported pain scales.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02711592
Brief Title
Pharmacogenomics Information in Enhancing Post-operative Total Joint Replacement Pain Management: a Pilot Study
Official Title
Utilizing Pharmacogenomics Information in Enhancing Post-operative Total Joint Replacement Pain Management: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Terminated
Why Stopped
Lack of enrollment
Study Start Date
October 5, 2016 (Actual)
Primary Completion Date
August 22, 2019 (Actual)
Study Completion Date
August 22, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TriHealth Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthroplasty, Replacement, Knee, Pain, Postoperative
Keywords
Orthopaedic Pain Management
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Genetic Panel for Analgesics
Arm Type
Other
Arm Description
Genetic testing for analgesics prior to surgery will be conducted. The subject will receive postoperative analgesia based on test results.
Intervention Type
Genetic
Intervention Name(s)
Genetic Panel for Analgesics
Intervention Description
All patients will receive genetic test panel to determine individualized optimal pain management following Total Knee Arthroplasty.
Primary Outcome Measure Information:
Title
Pain Scores
Description
Numerical patient reported pain scales.
Time Frame
Surgery to 6 weeks postop (+/- 2 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Snyder, MD
Organizational Affiliation
TriHealth Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Good Samaritan Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pharmacogenomics Information in Enhancing Post-operative Total Joint Replacement Pain Management: a Pilot Study
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