CYP2D6 Genotype-guided Management of Opioid Analgesics in Patients Undergoing Elective Ventral Hernia Repairs

University of Florida

Status: Active, not recruiting

Conditions: Ventral Hernia

Treatments: Other: Opioid pain medication prescribed based on CYP2D6 genotype testing PLUS Acetaminophen and Gabapentin; Other: Acetaminophen and Gabapentin: standard postoperative pain medications

Study type: Interventional

Funder types: Other

Identifiers

NCT06565546

202401069

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

CYP2D6 genotype testing-treatment

Experimental group

Description:

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.

Treatment:

Other: Opioid pain medication prescribed based on CYP2D6 genotype testing PLUS Acetaminophen and Gabapentin

CYP2D6 genotype testing-control

Active Comparator group

Description:

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.

Treatment:

Other: Acetaminophen and Gabapentin: standard postoperative pain medications