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

N/AActive Not RecruitingNCT06565546

University of Florida100 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

100

Conditions

Ventral Hernia

Interventions

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Florida Jacksonville

Jacksonville, Florida, United States

Outcomes

Primary Outcomes

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.

Time frame: 6 months

Secondary Outcomes

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.

Time frame: 6 months

Data from ClinicalTrials.gov

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