Arthroplasty, Replacement, KneeNCT02711592
Pharmacogenomics Information in Enhancing Post-operative Total Joint Replacement Pain Management: a Pilot Study
A study testing Genetic Panel for Analgesics in people with Arthroplasty, Replacement, Knee and Pain, Postoperative, run by TriHealth Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Replacement, Knee, Pain, Postoperative
- What is being tested?
- Genetic Panel for Analgesics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2016to 22 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Genetic Panel for Analgesics
- Keywords
- Orthopaedic Pain Management
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetic Panel for AnalgesicsGenetic
All patients will receive genetic test panel to determine individualized optimal pain management following Total Knee Arthroplasty.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Genetic: Genetic Panel for Analgesics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores
Numerical patient reported pain scales.
Measured: Surgery to 6 weeks postop (+/- 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study start5 Oct 2016
- Primary completion22 Aug 2019
- Study completion22 Aug 2019
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Replacement, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- TriHealth Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Snyder, MD, Principal investigator, TriHealth Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02711592
- Sponsor's protocol ID
- 15-037
- Status last verified
- Oct 2018
- First submitted
- 13 Mar 2016
- Last updated
- 25 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing Pharmacogenomics Information in Enhancing Post-operative Total Joint Replacement Pain Management: A Pilot Study
- ClinicalTrials.gov ID
- NCT02711592
- Acronym / sponsor ID
- 15-037
- Keywords
- Orthopaedic Pain Management
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment
- Enrolment
- 4 participants (actual)
- Lead sponsor
- TriHealth Inc.University, hospital or other
- Study start
- 5 Oct 2016 (actual)
- Primary completion
- 22 Aug 2019 (actual)
- Study completion
- 22 Aug 2019 (actual)
- First posted
- 17 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Genetic Panel for Analgesics | Other | Genetic: Genetic Panel for AnalgesicsGenetic testing for analgesics prior to surgery will be conducted. The subject will receive postoperative analgesia based on test results. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genetic Panel for AnalgesicsAll patients will receive genetic test panel to determine individualized optimal pain management following Total Knee Arthroplasty. | Genetic | Genetic Panel for Analgesics |
Primary outcome
Pain Scores
Time frame: Surgery to 6 weeks postop (+/- 2 weeks)
Numerical patient reported pain scales.
Results and safety
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Snyder, MD principal investigator
TriHealth Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Genetic Panel for Analgesics in people with Arthroplasty, Replacement, Knee and Pain, Postoperative, run by TriHealth Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Scores (time frame: Surgery to 6 weeks postop (+/- 2 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2021.