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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06565546

Enrollment

100

Registered

2024-08-22

Start date

2025-01-29

Completion date

2026-10-01

Last updated

2026-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventral Hernia

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.

Interventions

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

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

OTHERAcetaminophen and Gabapentin: standard postoperative pain medications

Participants will receive standard postoperative pain medications

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORRuchir Puri, MD

Associate Professor

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 8, 2026