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



Status:Recruiting
Conditions:Post-Surgical Pain, Orthopedic
Therapuetic Areas:Musculoskeletal, Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:10/20/2018
Start Date:March 2016
End Date:March 2019
Contact:Alexandra N Sympson, BA
Email:alexandra_sympson@trihealth.com
Phone:513-862-1904

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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.

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.

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
We found this trial at
1
site
Cincinnati, Ohio 45220
Principal Investigator: Mark A Snyder, MD
Phone: 513-862-1904
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mi
from
Cincinnati, OH
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