CYP2D6 Genotype-guided Management of Opioid Analgesics in Patients Undergoing Elective Ventral Hernia Repairs
Not Applicable
Recruiting
- Conditions
- Ventral Hernia
- Registration Number
- NCT06565546
- Lead Sponsor
- University of Florida
- Brief 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. Assess the efficacy (PROMIS Pain Intensity and Hernia-Related QOL) of a CYP2D6-guided opioid prescribing approach for patients undergoing elective VHRs.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
- > 18 years age undergoing a ventral hernia repair (VHR) ≥1.5 cm in diameter with mesh.
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Determine the feasibility of a CYP2D6-guided opioid prescribing by the percentage enrolled of patients undergoing elective VHRs compared to usual care. 6 months Percentage of potential participants approached will enroll and complete study.
- Secondary Outcome Measures
Name Time Method Assess the efficacy of a CYP2D6-guided opioid prescribing approach for patients undergoing elective VHRs. 6 months Participants may report improved post-operative pain control and quality of life.
Trial Locations
- Locations (1)
University of Florida Jacksonville
🇺🇸Jacksonville, Florida, United States
University of Florida Jacksonville🇺🇸Jacksonville, Florida, United StatesJennifer MullContact904-244-7988Jennifer.Mull@jax.ufl.edu