Genotype-Guided Opioid Management for Ventral Hernia
Recruiting in Palo Alto (17 mi)
Overseen byJana Sacco, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Florida
Must not be taking: Opioids
Disqualifiers: Small hernia, Emergency surgery, Pregnancy, others
No Placebo Group
Trial Summary
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.
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.
12345Is 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.
12346How 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.
12346Eligibility Criteria
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.Inclusion Criteria
I am over 18 and having a hernia repair with mesh for a hernia larger than 1.5 cm.
Exclusion Criteria
I have had an emergency surgery.
Allergy to opioids
I have a small hernia (less than 1.5 cm).
+3 more
Trial Timeline
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: CYP2D6 genotype testing-treatmentExperimental Treatment1 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-controlActive Control1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Florida JacksonvilleJacksonville, FL
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Who Is Running the Clinical Trial?
University of FloridaLead Sponsor
References
A hybrid implementation-effectiveness randomized trial of CYP2D6-guided postoperative pain management. [2023]Cytochrome P450 2D6 (CYP2D6) genotype-guided opioid prescribing is limited. The purpose of this type 2 hybrid implementation-effectiveness trial was to evaluate the feasibility of clinically implementing CYP2D6-guided postsurgical pain management and determine that such an approach did not worsen pain control.
Implementation of CYP2D6-guided opioid therapy at Cincinnati Children's Hospital Medical Center. [2023]We describe the implementation of CYP2D6-focused pharmacogenetic testing to guide opioid prescribing in a quaternary care, nonprofit pediatric academic medical center.
Implementing a pragmatic clinical trial to tailor opioids for acute pain on behalf of the IGNITE ADOPT PGx investigators. [2023]Opioid prescribing for postoperative pain management is challenging because of inter-patient variability in opioid response and concern about opioid addiction. Tramadol, hydrocodone, and codeine depend on the cytochrome P450 2D6 (CYP2D6) enzyme for formation of highly potent metabolites. Individuals with reduced or absent CYP2D6 activity (i.e., intermediate metabolizers [IMs] or poor metabolizers [PMs], respectively) have lower concentrations of potent opioid metabolites and potentially inadequate pain control. The primary objective of this prospective, multicenter, randomized pragmatic trial is to determine the effect of postoperative CYP2D6-guided opioid prescribing on pain control and opioid usage. Up to 2020 participants, age ≥8 years, scheduled to undergo a surgical procedure will be enrolled and randomized to immediate pharmacogenetic testing with clinical decision support (CDS) for CYP2D6 phenotype-guided postoperative pain management (intervention arm) or delayed testing without CDS (control arm). CDS is provided through medical record alerts and/or a pharmacist consult note. For IMs and PM in the intervention arm, CDS includes recommendations to avoid hydrocodone, tramadol, and codeine. Patient-reported pain-related outcomes are collected 10 days and 1, 3, and 6 months after surgery. The primary outcome, a composite of pain intensity and opioid usage at 10 days postsurgery, will be compared in the subgroup of IMs and PMs in the intervention (n = 152) versus the control (n = 152) arm. Secondary end points include prescription pain medication misuse scores and opioid persistence at 6 months. This trial will provide data on the clinical utility of CYP2D6 phenotype-guided opioid selection for improving postoperative pain control and reducing opioid-related risks.
Pharmacogenetics: A Precision Medicine Approach to Combatting the Opioid Epidemic. [2023]Ineffective pain control is the most commonly cited reason for misuse of prescription opioids and is influenced by genetics. In particular, the gene encoding the CYP2D6 enzyme, which metabolizes some of the most commonly prescribed opioids (e.g., tramadol, hydrocodone) to their more potent forms, is highly polymorphic and can lead to reduced concentrations of the active metabolites and decreased opioid effectiveness. Consideration of the CYP2D6 genotype may allow for predicting opioid response and identifying patients who are likely to respond well to lower potency opioids as well as those who may derive greater pain relief from non-opioid analgesics versus certain opioids. There is emerging evidence that a CYP2D6-guided approach to pain management improves pain control and reduces opioid consumption and thus may be a promising means for combating opioid misuse. Clinical practice guidelines are available for select opioids and other analgesics to support medication and dose selection based on pharmacogenetic data. This article describes the evidence supporting genotype-guided pain management as a means of improving pain control and reducing opioid misuse and clinical recommendations for genotype-guided analgesic prescribing. In addition, a "how to" guide using patient case examples is provided to demystify the process for implementing pharmacogenetics-guided pain management in order to optimize analgesia and minimize adverse effects. Optimizing pain management through genotype-guided approaches may ultimately provide safer and more effective therapy for pain control while decreasing the risk for opioid misuse.
Suspected opioid overdose case resolved by CYP2D6 genotyping. [2020]A 14-year-old female with suspected narcotic overdose had CYP2D6 genotyping performed to verify opiate intoxication. The role of pharmacogenetics in pain management and individualization of opiate pharmacotherapy is discussed.
Maximizing patient safety when prescribing opioids for pain management. [2023]Cytochrome P450 enzyme metabolism is altered by environmental and genetic factors, which can affect the efficacy and safety of opioids. This article describes CYP polymorphisms and how pharmacogenetic testing could be used to help clinicians make safer decisions about opioid use in patients.