Persistent Post Operative Opioid UsePhase 4NCT06669650
Personalized Post-Operative Pain Management
A Phase 4 study testing PGx guided personalized post-operative pain management, Oxycodone and Hydromorphone in people with Persistent Post Operative Opioid Use and Post-surgical Pain, run by University of Tennessee Graduate School of Medicine at 1 site in United States.
Trial summary
The main questions this study aims to answer are: Does perioperative PGx personalized opiate therapy reduce persistent post-operative opioid use dependency, improve pain management and reduce opiate related adverse events in opioid naïve patients after surgery? Participants will: Take hydromorphone if the PGx results… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Persistent Post Operative Opioid Use, Post-surgical Pain
- What is being tested?
- PGx guided personalized post-operative pain management, Oxycodone and Hydromorphone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2024to Dec 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1.18-85 years of age 2.Able to read and understand study procedures. 3.Willing to participate and sign an ICF. 4.Opioid naïve 90 days prior to surgery.
Who cannot join
- <18 years of age and >85 years of age
- Unable to understand study procedures.
- Unwilling to give consent.
- Patients with cognitive impairment that can affect their ability to give consent.
- Previous Surgery <14 days from time of enrollment.
- Allergies to study intervention or oxycodone.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Tennessee Graduate School of Medicine
Knoxville, Tennessee, 37920
About this study
Official title: Personalized Post-Operative Opiate Prescriptions Based on Pharmacogenetics of CytochromeP450, COMT, and OPRM1
The main questions this study aims to answer are:
Does perioperative PGx personalized opiate therapy reduce persistent post-operative opioid use dependency, improve pain management and reduce opiate related adverse events in opioid naïve patients after surgery?
Participants will:
Take hydromorphone if the PGx results determine they have a SNP indicating high or low metabolic activity in the CYP2D6 enzyme.
Complete a 7-day pain diary post-discharge. Complete a follow-up phone call once per month for 90 days.
- Being tested
- PGx guided personalized post-operative pain management, Oxycodone, Hydromorphone
- Keywords
- CYP2D6 SNPs, OPRM1 SNPs, COMT SNPs, Pharmacogenomics
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PGx guided personalized post-operative pain managementOther
Patients in the intervention group will receive post operative opioid therapy based on their pharmacogenomic results. Patients who are poor CYP2D6 metabolizers or rapid CYP2D6 metabolizers with moderate or severe pain, will be prescribed either oral hydromorphone 2mg every 4 hours as needed or oral hydromorphone 4mg every 4 hours as needed, respectively. Patients who are intermediate or normal CYP2D6 metabolizers with moderate or severe pain will receive oxycodone 5mg or oxycodone 10mg every 4 hours as needed respectively similar to the treatment offered to the control subjects. Normal or intermediate CYP2D6 metabolizers who are concomitantly taking a drug which is a strong CYP2D6 inducer will be treated as if they are in the rapid metabolizer group, and normal or intermediate patients that are concomitantly taking a drug which is a strong CYP2D6 inhibitor will be treated as if they were a poor metabolizer.
OxycodoneDrug
oxycodone
HydromorphoneDrug
hydromorphone
| Study group | Role | What they receive |
|---|---|---|
| Standard post-operative pain management (control) | Active comparator | Patients in the control groups will follow the current hospital standard of care and receive oxycodone 5mg every 4 hours as needed for moderate pain and oxycodone 10mg every four hours as needed for severe pain. Receives: Other: PGx guided personalized post-operative pain management; Drug: Oxycodone |
| Pharmacogenomics (PGx) guided treatment (hydromorphone) | Experimental | Patients who are poor CYP2D6 metabolizers or rapid CYP2D6 metabolizers with moderate or severe pain, will be prescribed either oral hydromorphone 2mg every 4 hours as needed or oral hydromorphone 4mg every 4 hours as needed, respectively. Receives: Other: PGx guided personalized post-operative pain management; Drug: Hydromorphone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Persistent Post-Operative Opioid Use
To determine the overall difference in the number of post-operative opioid prescriptions in 90 days using PGx guided post operative medication
Measured: 90 days
Secondary outcomes (1)
Post-Surgical Pain
To determine if PGx guided medication improves post-operative pain scores compared to similar patients who are given the standard current post operative opiate treatment. The scores are being rated using the Face, Legs, Activity, Cry and Consolability scale ranging from a minimum value of 0 to a maximum value of 10.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start25 Sep 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Post Operative Opioid UseStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Standard of Care (oxycodone) versus intervention group (hydromorphone)
- Masking
- None (open label)
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tennessee Graduate School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Trey Henderson, University of Tennessee Graduate School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06669650
- Sponsor's protocol ID
- 5226
- Other IDs
- CORNET Award
- Status last verified
- Oct 2024
- First submitted
- 30 Oct 2024
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Post-Operative Opiate Prescriptions Based on Pharmacogenetics of CytochromeP450, COMT, and OPRM1
- ClinicalTrials.gov ID
- NCT06669650
- Acronym / sponsor ID
- 5226
- Keywords
- CYP2D6 SNPs, OPRM1 SNPs, COMT SNPs, Pharmacogenomics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- University of Tennessee Graduate School of MedicineUniversity, hospital or other
- Study start
- 25 Sep 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 1 Nov 2024 (actual)
- 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 main questions this study aims to answer are:
Does perioperative PGx personalized opiate therapy reduce persistent post-operative opioid use dependency, improve pain management and reduce opiate related adverse events in opioid naïve patients after surgery?
Participants will:
Take hydromorphone if the PGx results determine they have a SNP indicating high or low metabolic activity in the CYP2D6 enzyme.
Complete a 7-day pain diary post-discharge. Complete a follow-up phone call once per month for 90 days.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Standard of Care (oxycodone) versus intervention group (hydromorphone)
| Arm | Type | Receives |
|---|---|---|
| Standard post-operative pain management (control) | Active comparator | Other: PGx guided personalized post-operative pain management, Drug: OxycodonePatients in the control groups will follow the current hospital standard of care and receive oxycodone 5mg every 4 hours as needed for moderate pain and oxycodone 10mg every four hours as needed for severe pain. |
| Pharmacogenomics (PGx) guided treatment (hydromorphone) | Experimental | Other: PGx guided personalized post-operative pain management, Drug: HydromorphonePatients who are poor CYP2D6 metabolizers or rapid CYP2D6 metabolizers with moderate or severe pain, will be prescribed either oral hydromorphone 2mg every 4 hours as needed or oral hydromorphone 4mg every 4 hours as needed, respectively. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1.18-85 years of age 2.Able to read and understand study procedures. 3.Willing to participate and sign an ICF. 4.Opioid naïve 90 days prior to surgery.
Key exclusion criteria (6 listed)
- <18 years of age and >85 years of age
- Unable to understand study procedures.
- Unwilling to give consent.
- Patients with cognitive impairment that can affect their ability to give consent.
- Previous Surgery <14 days from time of enrollment.
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 |
|---|---|---|
| PGx guided personalized post-operative pain managementPatients in the intervention group will receive post operative opioid therapy based on their pharmacogenomic results. Patients who are poor CYP2D6 metabolizers or rapid CYP2D6 metabolizers with moderate or severe pain, will be prescribed either oral hydromorphone 2mg every 4 hours as needed or oral hydromorphone 4mg every 4 hours as needed, respectively. Patients who are intermediate or normal CYP2D6 metabolizers with moderate or severe pain will receive oxycodone 5mg or oxycodone 10mg every 4 hours as needed respectively similar to the treatment offered to the control subjects. Normal or intermediate CYP2D6 metabolizers who are concomitantly taking a drug which is a strong CYP2D6 inducer will be treated as if they are in the rapid metabolizer group, and normal or intermediate patients that are concomitantly taking a drug which is a strong CYP2D6 inhibitor will be treated as if they were a poor metabolizer. | Other | Pharmacogenomics (PGx) guided treatment (hydromorphone), Standard post-operative pain management (control) |
| Oxycodoneoxycodone | Drug | Standard post-operative pain management (control) |
| Hydromorphonehydromorphone | Drug | Pharmacogenomics (PGx) guided treatment (hydromorphone) |
Primary outcome
Persistent Post-Operative Opioid Use
Time frame: 90 days
To determine the overall difference in the number of post-operative opioid prescriptions in 90 days using PGx guided post operative medication
1 secondary outcome
Post-Surgical Pain
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PGx guided personalized post-operative pain management, Oxycodone and Hydromorphone in people with Persistent Post Operative Opioid Use and Post-surgical Pain, run by University of Tennessee Graduate School of Medicine 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 6 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: under way, not looking for participants, as of the sponsor's last update on 1 Nov 2024. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Persistent Post-Operative Opioid Use (time frame: 90 days). 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 1 Nov 2024.