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

NCT06565546 | Active Not Recruiting

• 1 other identifier: 202401069
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventral Hernia

Outcome Measures

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.

  Percentage of potential participants approached will enroll and complete study.

  6 months

Secondary Outcomes (1)

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

  6 months

Study Arms (2)

CYP2D6 genotype testing-treatment

EXPERIMENTAL

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.

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

CYP2D6 genotype testing-control

ACTIVE COMPARATOR

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.

Other: Acetaminophen and Gabapentin: standard postoperative pain medications

Interventions

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

CYP2D6 genotype testing-treatment

Acetaminophen and Gabapentin: standard postoperative pain medications OTHER

Participants will receive standard postoperative pain medications

CYP2D6 genotype testing-control

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 18 years age undergoing a ventral hernia repair (VHR) ≥1.5 cm in diameter with mesh.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida Jacksonville

Jacksonville, Florida, 32209, United States

Location

MeSH Terms

Conditions

Hernia, Ventral

Interventions

Acetaminophen; Gabapentin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Jana Sacco, MD

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 22, 2024
• Study Start: January 29, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 8, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)