Persistent Post Operative Opioid Use, Post-surgical Pain
Conditions
Keywords
CYP2D6 SNPs, OPRM1 SNPs, COMT SNPs, Pharmacogenomics
Brief summary
The main questions this study aims to answer are: Does perioperative PGx personalized opiate therapy reduce persistent post-operative opioid use dependency, improve pain management and reduce opiate related adverse events in opioid naïve patients after surgery? Participants will: Take hydromorphone if the PGx results determine they have a SNP indicating high or low metabolic activity in the CYP2D6 enzyme. Complete a 7-day pain diary post-discharge. Complete a follow-up phone call once per month for 90 days.
Interventions
OTHERPGx guided personalized post-operative pain management
Patients in the intervention group will receive post operative opioid therapy based on their pharmacogenomic results. Patients who are poor CYP2D6 metabolizers or rapid CYP2D6 metabolizers with moderate or severe pain, will be prescribed either oral hydromorphone 2mg every 4 hours as needed or oral hydromorphone 4mg every 4 hours as needed, respectively. Patients who are intermediate or normal CYP2D6 metabolizers with moderate or severe pain will receive oxycodone 5mg or oxycodone 10mg every 4 hours as needed respectively similar to the treatment offered to the control subjects. Normal or intermediate CYP2D6 metabolizers who are concomitantly taking a drug which is a strong CYP2D6 inducer will be treated as if they are in the rapid metabolizer group, and normal or intermediate patients that are concomitantly taking a drug which is a strong CYP2D6 inhibitor will be treated as if they were a poor metabolizer.
DRUGOxycodone
oxycodone
DRUGHydromorphone
hydromorphone
Sponsors
University of Tennessee Graduate School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Standard of Care (oxycodone) versus intervention group (hydromorphone)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
1.18-85 years of age 2.Able to read and understand study procedures. 3.Willing to participate and sign an ICF. 4.Opioid naïve 90 days prior to surgery.
Exclusion criteria
1. \<18 years of age and \>85 years of age 2. Unable to understand study procedures. 3. Unwilling to give consent. 4. Patients with cognitive impairment that can affect their ability to give consent. 5. Previous Surgery \<14 days from time of enrollment. 6. Allergies to study intervention or oxycodone.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Persistent Post-Operative Opioid Use | 90 days | To determine the overall difference in the number of post-operative opioid prescriptions in 90 days using PGx guided post operative medication |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-Surgical Pain | 7 days | To determine if PGx guided medication improves post-operative pain scores compared to similar patients who are given the standard current post operative opiate treatment. The scores are being rated using the Face, Legs, Activity, Cry and Consolability scale ranging from a minimum value of 0 to a maximum value of 10. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Opioid Related Adverse Events | 90 days | To determine if PGx guided medication reduces total opioid related adverse events compared to standard post operative opiate therapy. |
Countries
United States
Outcome results
None listed