CYP2D6 Genotype-guided Management of Opioid Analgesics in Patients Undergoing Elective Ventral Hernia Repairs
Not Applicable
Recruiting
- Conditions
- Ventral Hernia
- Interventions
- Other: Opioid pain medication prescribed based on CYP2D6 genotype testing PLUS Acetaminophen and Gabapentin
- 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
- Arm && Interventions
Group Intervention Description CYP2D6 genotype testing-treatment Opioid pain medication prescribed based on CYP2D6 genotype testing PLUS Acetaminophen and Gabapentin 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.
- 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