Clinical trial NCT03534063: Implementing Genomics in Practice (IGNITE): CYP2D6 Genotype-Guided Pain Management in Patients Undergoing Arthroplasty Surgery
Official title: Implementing Genomics in Practice (IGNITE): CYP2D6 Genotype-Guided Pain Management in Patients Undergoing Arthroplasty Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Keywords: Arthroplasty Surgery
Genotype-Guided Pain Management
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: University of Florida Health
First posted: 2018-05-23
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This will be a randomized, open-labeled pilot pragmatic clinical trial. Patients undergoing arthroplasty surgery will be recruited from the University of Florida (UF) Health Gainesville and the Villages Orthopedic clinics for CYP2D6 pharmacogenetic testing to manage post-surgical pain. Patients will be randomized 2:1 to either usual care or genotype-guided care. The aims of the study were to: 1) test the feasibility of a genotype-guided opioid prescribing approach for patients undergoing an outpatient surgical procedure, a group at high risk for persistent opioid use; and 2) evaluate the effect of genotype-guided post-surgical pain management on pain control and opioid prescribing.

Detailed description: This study was a randomized, open-label, type 2 hybrid implementation effectiveness trial conducted to test the hypothesis that CYP2D6 genotype-guided management of post-surgical pain 1) was feasible, and 2) reduced the use of codeine, tramadol, hydrocodone, and oxycodone in Poor Metabolizers (PMs), Intermediate Metabolizers (IMs), and Ultrarapid metabolizers (UMs). In addition to the reduced use of opioids listed above, we aimed to see if participants had improved post-operative pain control in PMs/IMs and reduced Drug Enforcement Administration (DEA) Schedule II (C-II) opioids in Normal Metabolizers (NMs). Patients scheduled to undergo arthroplasty surgery were recruited from the UF Health Gainesville and the Villages Orthopedic clinics. Patients were randomized 2:1 to a genotype-guided versus usual care approach. For patients with CYP2D6 PM, IM or UM phenotype based on genotype or drug interactions, a recommendation to avoid hydrocodone, tramadol, codeine, and oxycodone were made. In NMs, tramadol was recommended, given evidence of its lower potential addiction risk than C-II opioids. Patient-Reported Outcomes Measurement Information System (PROMIS) measures were administered at baseline (within 30 days of surgery) and 2 weeks ± 4 days post-surgery for patients in each arm. Pain scores and assessments of physical functioning, emotional functioning, and mobility from the PROMIS measures and utilization of pain medications during the 2-week period following surgery were also compared between groups.

Eligibility criteria: Inclusion Criteria:

* Scheduled to undergo total joint arthroplasty at area hospital
* Primary unilateral total hip or knee arthroplasty scheduled within approximately 6 months of the initial evaluation clinic visit

Exclusion Criteria:

* Patients scheduled to undergo a revision or bilateral procedure
* Receiving chronic opioid therapy, defined as the use of opioids on most days for \> 3 month
* Allergy to opioids

Primary outcomes:
measure: Percentage of Patients Who Agreed to Participate
timeFrame: 12 months
measure: Percentage of Participants With a Clinical Phenotype Warranting Alternative Therapy
timeFrame: An average of 2 weeks after genotype sample collection
measure: Percentage of Participants in the Genotype-guided Arm for Whom a Clinical Phenotype-guided Recommendation Was Accepted by the Clinician
timeFrame: An average of 2 months after genotype results returned
measure: Opioid Utilization
timeFrame: 2 weeks after surgery
Secondary outcomes:
measure: Composite Pain Intensity
timeFrame: 2 weeks after surgery
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health at the University of Florida
state: Florida
city: Gainesville
country: United States
facility: Unversity of Florida
state: Florida
city: Summerfield
country: United States
facility: UF Health Orthopaedic--Villages
state: Florida
Study officials:
affiliation: University of Florida
name: Larisa Cavallari, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thomas CD, Parvataneni HK, Gray CF, Deen JT, Prieto HA, Pulido LF, Elsey AR, Elwood EN, Starostik P, Gong Y, Fillingim RB, Johnson JA, Cavallari LH. A hybrid implementation-effectiveness randomized trial of CYP2D6-guided postoperative pain management. Genet Med. 2021 Apr;23(4):621-628. doi: 10.1038/s41436-020-01050-4. Epub 2021 Jan 8.