Genotype-Guided Opioid Management for Ventral Hernia

Overseen By Ruchir Puri, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Must not be taking: Opioids

Disqualifiers: Small hernia, Emergency surgery, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on chronic opioid therapy, you would not be eligible to participate.

Is CYP2D6 genotype-guided opioid management safe for humans?

Research suggests that using CYP2D6 genotype-guided opioid management can improve pain control and reduce opioid misuse, which may enhance safety by helping doctors choose the right pain medication and dose for each person. ^{1 2 3 4 5}

How does genotype-guided opioid management differ from other treatments for ventral hernia?

This treatment is unique because it uses genetic testing to guide opioid prescribing, tailoring pain management based on how a patient's body processes certain drugs. This approach aims to improve pain control and reduce the risk of opioid misuse by considering individual genetic differences, unlike standard treatments that do not account for these variations. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment CYP2D6 Genotype-guided Opioid Management for Ventral Hernia?

Research shows that using a person's genetic information (CYP2D6 genotype) to guide opioid prescribing can improve pain control and reduce the risk of opioid misuse. This approach has been effective in managing postoperative pain by tailoring opioid selection to individual genetic profiles, which may lead to better pain relief and safer use of opioids. ^{1 2 3 4 6}

Who Is on the Research Team?

Jana Sacco, MD

Principal Investigator

Assistant Professor

Are You a Good Fit for This Trial?

This trial is for adults over 18 years old who are having a ventral hernia repair with mesh, where the hernia is at least 1.5 cm in diameter. It's not specified who can't join, but typically those with health issues that could interfere with the study or safety concerns would be excluded.

Exclusion Criteria

I have had an emergency surgery.

Allergy to opioids

I have a small hernia (less than 1.5 cm).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Genotype Testing

CYP2D6 genotype testing performed preoperatively to guide opioid prescribing

1 week

Postoperative Treatment

Participants receive opioid analgesics guided by CYP2D6 genotype results during the postoperative period

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pain control and quality of life assessments

6 months

What Are the Treatments Tested in This Trial?

Interventions

• CYP2D6 Genotype-guided Opioid Management

Trial Overview The trial tests if prescribing opioid pain medication based on individual genetic testing (CYP2D6 genotype) plus standard pain meds like Acetaminophen and Gabapentin improves pain management and quality of life after elective ventral hernia repairs compared to usual care.

How Is the Trial Designed?

Group I: CYP2D6 genotype testing-treatment Experimental Treatment 1 Intervention

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.

Group II: CYP2D6 genotype testing-control Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Published Research Related to This Trial

A study involving 260 patients undergoing total joint arthroplasty showed that using CYP2D6 genotype-guided opioid prescribing is feasible, with 20% of participants identified as high-risk metabolizers receiving alternative opioids instead of standard ones.

Patients in the genotype-guided group consumed less opioids (200 vs. 230 morphine milligram equivalents) while experiencing similar pain levels, indicating that this approach can reduce opioid use without worsening pain control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A hybrid implementation-effectiveness randomized trial of CYP2D6-guided postoperative pain management. Thomas, CD., Parvataneni, HK., Gray, CF., et al.[2023]

Cincinnati Children's Hospital implemented CYP2D6-focused pharmacogenetic testing to guide opioid prescribing, particularly for children, which has evolved alongside FDA guidelines and testing advancements since 2004.

The testing improved compliance among prescribers for genotype-guided prescribing of oxycodone, although there was some skepticism about its utility for this specific medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of CYP2D6-guided opioid therapy at Cincinnati Children's Hospital Medical Center. Ramsey, LB., Prows, CA., Chidambaran, V., et al.[2023]

This study will assess the impact of CYP2D6-guided opioid prescribing on pain management in up to 2020 participants undergoing surgery, focusing on those with reduced or absent CYP2D6 activity who may not respond well to standard opioids like hydrocodone, tramadol, and codeine.

The primary outcome will evaluate pain intensity and opioid usage 10 days post-surgery, aiming to demonstrate that personalized opioid prescribing can enhance pain control and minimize the risk of opioid misuse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing a pragmatic clinical trial to tailor opioids for acute pain on behalf of the IGNITE ADOPT PGx investigators. Cavallari, LH., Cicali, E., Wiisanen, K., et al.[2023]

Genetic variations in the CYP2D6 enzyme can significantly affect how well certain opioids work for pain relief, suggesting that understanding a patient's CYP2D6 genotype could help predict their response to opioid medications.

Using a genotype-guided approach to pain management has shown promise in improving pain control and reducing opioid use, which may help combat the misuse of prescription opioids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacogenetics: A Precision Medicine Approach to Combatting the Opioid Epidemic. Smith, DM., Stevenson, JM., Ho, TT., et al.[2023]

CYP2D6 genotyping was utilized in a 14-year-old female suspected of narcotic overdose to confirm opiate intoxication, highlighting the importance of genetic testing in understanding drug metabolism.

The study emphasizes the role of pharmacogenetics in personalizing pain management and optimizing opiate therapy, suggesting that genetic variations can significantly influence individual responses to narcotics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suspected opioid overdose case resolved by CYP2D6 genotyping. Shaw, KD., Amstutz, U., Jimenez-Mendez, R., et al.[2020]

Cytochrome P450 enzyme metabolism can be influenced by both environmental and genetic factors, which may impact how effectively and safely opioids work in patients.

Pharmacogenetic testing for CYP polymorphisms can assist clinicians in making more informed and safer decisions regarding opioid prescriptions, potentially improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maximizing patient safety when prescribing opioids for pain management. Judy, M., Sams, D., Poulton, S.[2023]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

A hybrid implementation-effectiveness randomized trial of CYP2D6-guided postoperative pain management. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Implementation of CYP2D6-guided opioid therapy at Cincinnati Children's Hospital Medical Center. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Implementing a pragmatic clinical trial to tailor opioids for acute pain on behalf of the IGNITE ADOPT PGx investigators. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Pharmacogenetics: A Precision Medicine Approach to Combatting the Opioid Epidemic. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Suspected opioid overdose case resolved by CYP2D6 genotyping. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Maximizing patient safety when prescribing opioids for pain management. [2023]