Clinical trial NCT05367609: Personalized Perioperative Analgesia Platform (PPAP) for Pediatric Spine Fusion Surgery (sIRB)
Official title: Personalized Perioperative Analgesia Platform (PPAP) for Pediatric Spine Fusion Surgery (sIRB)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: PPAP
Spine Fusion
Keywords: PPAP
Pediatric
Spine Fusion Surgery
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2022-05-10
Enrollment: 300
Sex: ALL
Minimum age (years): 10
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: PK sampling and genetic testing will determine the type of analgesia medication treatment the patient receives
Primary purpose: TREATMENT

Brief summary: The purpose of this collaborative CTSA application is to develop an innovative perioperative precision analgesia platform (PPAP) to improve analgesia and reduce serious immediate and long-term adverse outcomes of perioperative opioids in children undergoing painful surgery.

Detailed description: Aim 1. Develop and implement a perioperative precision analgesia platform (PPAP) by linking genomics to opioid metabolism, CPIC guidelines, precision dosing, clinical safety, and personalizing analgesia

Aim 2. Implement and evaluate PPAP in children undergoing major inpatient surgery, posterior spinal fusion (PSF)

1. Determine genetic factors predisposing children to immediate and long-term postoperative methadone and oxycodone related adverse effects including RD, PONV, opioid dependence, and CPSP The investigators postulate that specific CYP2B6, ABCB1, OPRM1, FAAH, and CYP2D6 variants identify children at risk for poor pain relief, RD, PONV, opioid dependence, and CPSP in the postoperative period.
2. Determine genetic variants-based perioperative dosing and outpatient prescribing of opioids

The investigators hypothesize that CYP2B6 and CYP2D6 variants will explain pharmacokinetic variations of methadone and oxycodone, determine the right doses, and implement precision opioid use for optimal clinical outcomes

Eligibility criteria: Inclusion Criteria:

* Children ages 10 to 21
* ASA physical status 1 to 3
* Undergoing Posterior-Lateral Spinal Fusion
* Receives in-patient opioids
* Prescribed opioids at discharge

Exclusion Criteria:

* Serious illness
* Preoperative severe pain
* Preoperative opioid use or misuse

Primary outcomes:
measure: Look at genetic factors predisposing children to immediate postoperative opioid-adverse effects Respiratory Depression (RD) and Postoperative Nausea and Vomiting (PONV)
timeFrame: Immediately post-surgery
measure: Look at genetic factors predisposing children to postoperative opioid-adverse effects Respiratory Depression (RD) and Postoperative Nausea and Vomiting (PONV) at genetic factors predisposing children to inadequate surgical pain relief with oxycodone
timeFrame: At home up to 1 year post-surgery
measure: Look at genetic factors predisposing children to inadequate surgical pain relief with oxycodone
timeFrame: Immediately post-surgery
measure: Look at genetic factors predisposing children to inadequate surgical pain relief with oxycodone
timeFrame: At home up to 1 year post-surgery
Secondary outcomes:
measure: Look at the impact of CYP2D6 variants on oxycodone's clinical dosing in children to see if specific variants correlate with a need for lower or higher doses of analgesic
timeFrame: Pre-operative to post-operative day 2
Other outcomes:
measure: Look at OPRM1 epigenetics and OPRM1, FAAH, GCH1, DRD2 variants to find correlations with chronic persistent surgical pain (CPSP) up to 1-year post-surgery
timeFrame: Post-operative up to 1-year
measure: Look at OPRM1 epigenetics and OPRM1, FAAH, GCH1, DRD2 variants to find correlations with opioid dependence (OD) up to 1-year post-surgery
timeFrame: Post-operative up to 1-year
Locations:
city: San Francisco
country: United States
facility: University of California
state: California
city: Indianapolis
country: United States
facility: Riley Children's Hospital
state: Indiana
city: Pittsburgh
country: United States
facility: UPMC Children's Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Senthilkumar Sadhasivam, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: