Clinical trial NCT05380531: Personalized Perioperative Analgesia Platform (PPAP) for Cesarean Section
Official title: Personalized Perioperative Analgesia Platform (PPAP) for Cesarean Section
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cesarean Section Complications
Opioid Use
Keywords: Opioid Exposure
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2022-05-19
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Interventional study with mother undergoing elective c-section and the infant
Primary purpose: TREATMENT

Brief summary: The purpose of this collaborative CTSA (Clinical and Translational Science Award) 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 breastfeeding mothers and their infants

Detailed description: The approach includes 1) development and implementation of an innovative PPAP infrastructure at participating CTSA hubs (Aim 1) and 2) to improve analgesia and reduce serious immediate and long-term adverse outcomes of perioperative opioids and precision dosing in nursing mothers and infants (Aim 2).

SPECIFIC AIMS: 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

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

Aim 2. Evaluate utility of PPAP in nursing mothers and their newborns following Cesarean Section The investigators hypothesize that CYP2D6 and other (ABCB1, and OPRM1) variants will explain clinical and pharmacokinetic variations of oxycodone, and PPAP implementation will reduce adverse effects in mothers and infants.

Eligibility criteria: Inclusion Criteria:

Adult women (\>18 yr) All races American Society of Anesthesiologists Classification (ASA) physical status: 1 to 3 undergoing elective Cesarean section that are willing to receive in-patient opioids.

Exclusion Criteria:

1. Health conditions including uncontrolled diabetes (gestational or pre-existing) or hypertension (pre-eclampsia, eclampsia, or chronic)
2. Any history of opioid misuse before or during pregnancy-per self-report and clinical notes
3. Preoperative severe pain and opioid use/misuse, allergy to oxycodone
4. Allergy to oxycodone
5. Significant neurological disorders, liver and renal diseases

Primary outcomes:
measure: Look at genetic factors predisposing patients to immediate postoperative opioid-adverse effects Respiratory Depression (RD) and Postoperative Nausea and Vomiting (PONV)
timeFrame: Immediately post-surgery during hospital stay
measure: Look at genetic factors predisposing patients to immediate postoperative opioid-adverse effects Respiratory Depression (RD) and Postoperative Nausea and Vomiting (PONV)
timeFrame: At home up to 1 year post-surgery
measure: Look at genetic factors predisposing patients to inadequate surgical pain relief with oxycodone
timeFrame: Immediately post-surgery during hospital stay
measure: Look at genetic factors predisposing patients 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 patients 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
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: Pittsburgh
country: United States
facility: UPMC Magee Women's Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Senthilkumar Sadhasivam, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: