Ventral HerniaNCT06565546
CYP2D6 Genotype-guided Management of Opioid Analgesics in Patients Undergoing Elective Ventral Hernia Repairs
A study testing Opioid pain medication prescribed based on CYP2D6 genotype testing PLUS Acetaminophen and Gabapentin and Acetaminophen and Gabapentin: standard postoperative pain medications in people with Ventral Hernia, run by University of Florida at 1 site in United States.
Trial summary
Pilot pragmatic trial using an implementation science approach to determine the feasibility of a CYP2D6-guided opioid prescribing for patients undergoing elective VHRs compared to usual care. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Ventral Hernia
- What is being tested?
- Opioid pain medication prescribed based on CYP2D6 genotype testing PLUS Acetaminophen and Gabapentin and Acetaminophen and Gabapentin: standard postoperative pain medications
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2025to Oct 2026
- Phase
- Interventional
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 18 years age undergoing a ventral hernia repair (VHR) ≥1.5 cm in diameter with mesh.
Who cannot join
- ventral hernia <1.5 cm
- primary ventral hernia repair (VHR) without a mesh
- emergency operative procedure
- receiving chronic opioid therapy (defined as use of opioids on most days for >3 months)
- allergy to opioids
- women of childbearing potential who have a positive pregnancy result as part of their standard pre-surgical workup
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida Jacksonville
Jacksonville, Florida, 32209
About this study
Official title: Feasibility and Efficacy of CYP2D6 Genotype-guided Management of Opioid Analgesics in Patients Undergoing Elective Ventral Hernia Repairs: A Pilot Pragmatic Trial
Pilot pragmatic trial using an implementation science approach to determine the feasibility of a CYP2D6-guided opioid prescribing for patients undergoing elective VHRs compared to usual care. Assess the efficacy (PROMIS Pain Intensity and Hernia-Related QOL) of a CYP2D6-guided opioid prescribing approach for patients undergoing elective VHRs.
- Conditions
- Ventral Hernia
- Being tested
- Opioid pain medication prescribed based on CYP2D6 genotype testing PLUS Acetaminophen and Gabapentin, Acetaminophen and Gabapentin: standard postoperative pain medications
- Medical subject headings
- Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid pain medication prescribed based on CYP2D6 genotype testing PLUS Acetaminophen and GabapentinOther
CYP2D6 genotype testing for assessment of medication metabolism to guide prescription of postoperative pain medication
Acetaminophen and Gabapentin: standard postoperative pain medicationsOther
Participants will receive standard postoperative pain medications
| Study group | Role | What they receive |
|---|---|---|
| CYP2D6 genotype testing-treatment | Experimental | CYP2D6 genotype testing performed preoperatively with results used to guide prescribing of opioid analgesics during the postoperative period to control pain. In addition, participants will receive standard of care postoperative pain medications. Receives: Other: Opioid pain medication prescribed based on CYP2D6 genotype testing PLUS Acetaminophen and Gabapentin |
| CYP2D6 genotype testing-control | Active comparator | CYP2D6 genotype testing performed preoperatively, results will be delayed until after operative procedure. Participants will receive standard of care postoperative pain medication prescriptions for pain management. Receives: Other: Acetaminophen and Gabapentin: standard postoperative pain medications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the feasibility of a CYP2D6-guided opioid prescribing by the percentage enrolled of patients undergoing elective VHRs compared to usual care.
Percentage of potential participants approached will enroll and complete study.
Measured: 6 months
Secondary outcomes (1)
Assess the efficacy of a CYP2D6-guided opioid prescribing approach for patients undergoing elective VHRs.
Participants may report improved post-operative pain control and quality of life.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start29 Jan 2025
- Primary completion1 Sep 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventral HerniaStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ruchir Puri, MD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06565546
- Sponsor's protocol ID
- 202401069
- Status last verified
- Apr 2026
- First submitted
- 13 Aug 2024
- Last updated
- 7 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Efficacy of CYP2D6 Genotype-guided Management of Opioid Analgesics in Patients Undergoing Elective Ventral Hernia Repairs: A Pilot Pragmatic Trial
- ClinicalTrials.gov ID
- NCT06565546
- Acronym / sponsor ID
- 202401069
- Conditions
- Ventral Hernia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 29 Jan 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 22 Aug 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.
Pilot pragmatic trial using an implementation science approach to determine the feasibility of a CYP2D6-guided opioid prescribing for patients undergoing elective VHRs compared to usual care. Assess the efficacy (PROMIS Pain Intensity and Hernia-Related QOL) of a CYP2D6-guided opioid prescribing approach for patients undergoing elective VHRs.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CYP2D6 genotype testing-treatment | Experimental | Other: Opioid pain medication prescribed based on CYP2D6 genotype testing PLUS Acetaminophen and GabapentinCYP2D6 genotype testing performed preoperatively with results used to guide prescribing of opioid analgesics during the postoperative period to control pain. In addition, participants will receive standard of care postoperative pain medications. |
| CYP2D6 genotype testing-control | Active comparator | Other: Acetaminophen and Gabapentin: standard postoperative pain medicationsCYP2D6 genotype testing performed preoperatively, results will be delayed until after operative procedure. Participants will receive standard of care postoperative pain medication prescriptions for pain management. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- > 18 years age undergoing a ventral hernia repair (VHR) ≥1.5 cm in diameter with mesh.
Key exclusion criteria (6 listed)
- ventral hernia <1.5 cm
- primary ventral hernia repair (VHR) without a mesh
- emergency operative procedure
- receiving chronic opioid therapy (defined as use of opioids on most days for >3 months)
- allergy to opioids
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 |
|---|---|---|
| Opioid pain medication prescribed based on CYP2D6 genotype testing PLUS Acetaminophen and GabapentinCYP2D6 genotype testing for assessment of medication metabolism to guide prescription of postoperative pain medication | Other | CYP2D6 genotype testing-treatment |
| Acetaminophen and Gabapentin: standard postoperative pain medicationsParticipants will receive standard postoperative pain medications | Other | CYP2D6 genotype testing-control |
Primary outcome
Determine the feasibility of a CYP2D6-guided opioid prescribing by the percentage enrolled of patients undergoing elective VHRs compared to usual care.
Time frame: 6 months
Percentage of potential participants approached will enroll and complete study.
1 secondary outcome
Assess the efficacy of a CYP2D6-guided opioid prescribing approach for patients undergoing elective VHRs.
Time frame: 6 months
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 7 Jul 2026.
- 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.
Ruchir Puri, MD principal investigator
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Opioid pain medication prescribed based on CYP2D6 genotype testing PLUS Acetaminophen and Gabapentin and Acetaminophen and Gabapentin: standard postoperative pain medications in people with Ventral Hernia, run by University of Florida 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 7 Jul 2026. 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?
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?
Determine the feasibility of a CYP2D6-guided opioid prescribing by the percentage enrolled of patients undergoing elective VHRs compared to usual care. (time frame: 6 months). 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 7 Jul 2026.