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?

This trial aims to determine if a person's genetic makeup, specifically the CYP2D6 liver enzyme that affects drug processing, can guide doctors in prescribing better pain management after ventral hernia repair surgery. It compares personalized opioid prescriptions based on genetic information to the usual pain management approach. The goal is to assess whether this method effectively reduces pain and improves quality of life. Individuals with hernias larger than 1.5 cm undergoing surgery with mesh may be suitable candidates for this trial. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance personalized medicine and improve post-surgical outcomes.

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.

What prior data suggests that CYP2D6 genotype-guided opioid management is safe for ventral hernia patients?

Research shows that using genetic testing to guide opioid prescriptions can be safe. This method involves checking genes to determine how the body processes pain medications. Studies have shown that this testing helps doctors select the right type and dose of pain medication, reducing side effects and improving pain control after surgery.

No direct evidence indicates serious safety concerns with this approach. Past studies have focused on its practicality and effectiveness rather than specific safety issues, suggesting that the treatment has been well-tolerated in previous research settings. However, as this approach is still new, ongoing research aims to confirm its safety for everyone. Prospective trial participants can use this information to weigh potential benefits and risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about genotype-guided opioid management for ventral hernia because it personalizes pain management by using a patient's genetic information. Unlike standard pain management options, which often involve a one-size-fits-all approach to prescribing opioids, this method tailors opioid prescriptions based on the CYP2D6 genotype. This could potentially improve pain control while minimizing side effects and the risk of opioid misuse. By precisely matching the type and dose of opioid to an individual's genetic makeup, this approach represents a significant step forward in personalized medicine.

What evidence suggests that CYP2D6 genotype-guided opioid management is effective for ventral hernia?

This trial will evaluate the effectiveness of using a person's genetic information, specifically their CYP2D6 gene, to guide opioid management after ventral hernia surgery. Participants in one arm will undergo CYP2D6 genotype testing before surgery, with results guiding opioid prescribing during recovery. Studies have shown that the CYP2D6 gene affects how the body processes certain drugs, including opioids, and this personalized approach can improve pain management without increasing pain levels. Evidence also indicates it might reduce the amount of opioids needed. This method has shown promise in maintaining pain levels and may enhance overall quality of life after surgery. ^{1 2 6 7 8}

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

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06565546

CYP2D6 Genotype-guided Management of Opioid ... Assess the efficacy (PROMIS Pain Intensity and Hernia-Related QOL) of a CYP2D6-guided opioid prescribing approach for patients undergoing elective VHRs.

2. pediatrics.med.jax.ufl.edu pediatrics.med.jax.ufl.edu/research/clinical-research-details/?studyid=426

Feasibility and efficacy of CYP2D6 genotype ... - Pediatrics Feasibility and efficacy of CYP2D6 genotype-guided management of opioid analgesics in patients undergoing elective ventral hernia repairs: A pilot pragmatic ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8525217/

A Hybrid Implementation-Effectiveness Randomized Trial of ... Data on pain intensity were collected to document that there were not obvious trends of the CYP2D6-guided approach leading to worse pain control, which in turn ...

4. bmcmedgenomics.biomedcentral.com bmcmedgenomics.biomedcentral.com/articles/10.1186/s12920-024-02064-6

Associations between (pharmaco-)genetic markers and ... We hypothesize that the CYP2D6 activity influences the development of postoperative pain after hernia surgery. Methods. This study is a ...

5. researchgate.net researchgate.net/publication/348342576_A_hybrid_implementation-effectiveness_randomized_trial_of_CYP2D6-guided_postoperative_pain_management

A hybrid implementation-effectiveness randomized trial of ... 17 Thomas et al demonstrated that implementing CYP2D6 genotype-guided postoperative pain management is feasible and may result in reduced opioid consumption ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11658386/

Associations between (pharmaco-)genetic markers and ... We hypothesize that the CYP2D6 activity influences the development of postoperative pain after hernia surgery. Methods. This study is a ...

7. go.drugbank.com go.drugbank.com/conditions/DBCOND0048185

Ventral Hernias (DBCOND0048185) CYP2D6 Genotype-guided Management of Opioid Analgesics in Patients Undergoing Elective Ventral Hernia Repairs, No drug interventions, diagnostic, Not Available ...

8. blueshieldca.com blueshieldca.com/content/dam/bsca/en/provider/docs/medical-policies/Pharmacogenetic-Testing-Pain-Management.pdf

Pharmacogenetic Testing for Pain Management The hybrid randomized trial concluded that preemptive CYP2D6-guided opioid selection is feasible in an elective surgery setting and that ...