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NCT Number: NCT06565546

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Ventral Hernia Hernia Hernia, Abdominal Hernia, Ventral Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida Jacksonville

Jacksonville, Florida, 32209, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

CYP2D6 genotype testing for assessment of medication metabolism to guide prescription of postoperative pain medication

Acetaminophen and Gabapentin: standard postoperative pain medications

Other

Participants will receive standard postoperative pain medications

Primary outcomes

  1. 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.

Secondary outcomes

  1. Assess the efficacy of a CYP2D6-guided opioid prescribing approach for patients undergoing elective VHRs.

    Time frame: 6 months

    Participants may report improved post-operative pain control and quality of life.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

Feasibility and Efficacy of CYP2D6 Genotype-guided Management of Opioid Analgesics in Patients Undergoing Elective Ventral Hernia Repairs: A Pilot Pragmatic Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 22, 2024
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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