Implementing Genomics in Practice (IGNITE): CYP2D6 Genotype-Guided Pain Management in Patients Undergoing Arthroplasty Surgery
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional

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.
    

Intervention name(s): CYP2D6-guided opioid therapy
Intervention type(s): Genetic
Intervention description(s): Using a standardized consult note, recommendations were made to avoid tramadol, hydrocodone, codeine, and oxycodone in PMs, IMs, and UMs and to use an alternative opioid (e.g. morphine, hydromorphone) or non-opioid (e.g. NSAID). Consideration of tramadol as the first-line opioid will be recommended for NMs.
Intervention MeSH terms: Analgesics, Opioid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Arthroplasty Surgery; Genotype-Guided Pain Management