Precision Opioid Care After Cesarean Delivery (PRECISE-CD)

NCT ID: NCT05280743

Last Updated: 2024-07-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 341 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-28
• Study Completion Date: 2024-06-01

Brief Summary

The purpose of this research is to study serious clinical problems from surgical pain and the use of oxycodone or other opioids in women having a Cesarean Delivery to improve the safety and efficacy of surgical pain relief. This research will ultimately improve the safety and efficacy of surgical pain relief with opioids by preoperative risk predictions and personalized care with the right dose of the right analgesic for each patient.

Detailed Description

The overall objective is to determine the impact of risk factors on oxycodone and other opioid's adverse postoperative outcomes and to personalize dosing in women having a Cesarean Delivery. For the purpose of this study, immediate adverse postoperative outcomes are characterized as Respiratory Depression (RD), Postoperative Nausea and Vomiting (PONV), and inadequate surgical pain relief. Long-term adverse postoperative outcomes are characterized as Chronic Persistent Surgical Pain (CPSP) and Opioid Dependence (OD).

The central hypothesis is that specific genetic factors in pain-opioid pathways significantly impact oxycodone and opioid dosing, analgesia, immediate adverse effects (RD and PONV), and long-term adverse outcomes (CPSP and OD).

The aims of this project are to validate genetic variants and to develop a test for preoperative risk prediction in lactating mothers and breastfed babies following cesarean delivery (CD). There is an urgent and unmet critical need for reliable technology to improve safety and effectiveness of opioid use in special populations.

Aim 1. Validate and identify genetic risk factors associated with postoperative opioid adverse effects, PONV and RD in adult nursing mothers following CD.

Investigators hypothesize that with standardized and genotype-blinded perioperative care, specific variants will identify nursing mothers at risk for opioid-induced RD and PONV (primary outcome), OD and severe pain following CD. In addition, genetic variants will identify risk for opioid-induced sedation and adverse effects in breastfed infants. In addition to clinical outcomes, the investigators will collect post-CD cost of care including length of stay.

Aim 2. Develop a laboratory-developed test (LDT) at University of Pittsburgh Genome Center (UGC) for preoperative genetic risk prediction and decision support for surgical patients to prevent adverse opioid outcomes. Investigators will develop a minimum viable product (MVP) (CPT code: 81227), a refined multi-gene panel in UGC's CLIA certified laboratory with a robust combinatorial pharmacogenetic decision support to personalize surgical analgesia with precise opioid use in children and adults, and to prevent RD, PONV, CPSP and OD.

Conditions

Cesarean Section Complications; Opioid Use

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

MATERNAL cohort

Nursing mothers who underwent Cesarean Delivery and who are receiving oxycodone to treat post-operative pain

Oxycodone

Intervention Type: DRUG

exposure to opioids after Cesarean Section

NEONATE-INFANT cohort

Neonate" encompasses a newborn from the age of birth until \<28 days of life. "Infant" refers to the period of 28 days of life until 1 year of life.

Oxycodone

Intervention Type: DRUG

exposure to opioids after Cesarean Section

Interventions

Oxycodone

exposure to opioids after Cesarean Section

Intervention Type: DRUG

Other Intervention Names

Opioid Exposure

Eligibility Criteria

Inclusion Criteria

• Pregnant Adult women (>18 y) and their infants
• All races
• ASA physical status 2 to 3
• Cesarean delivery at UPMC Magee
• Planned breast feeding mothers and their infants

Exclusion Criteria

• Serious illnesses or condition of either mother or infant precluding ability to participate in study procedures
• Multiple gestation pregnancies
• Preoperative severe pain and opioid use/misuse
• Allergy to oxycodone
• Women with opioid use disorder
• Any known condition that anticipates neonatal observation in NICU immediately after birth
• General anesthesia anticipated or converted intraoperatively
• Expected non-viable current gestation or serious neonatal health comorbidities anticipated prior to delivery
• Severe neurological disorder: any known untreated or uncontrolled seizure disorder, pre-eclampsia with severe features, pre-eclampsia requiring magnesium, elevated ICP other than benign intracranial hypertension condition, or conditions at the discretion of PI
• Liver disease: any known abnormal live function tests, or conditions at the discretion of PI
• Renal diseases: any chronic or acute renal insufficiency, or pre-eclampsia diagnosis with abnormal renal function i.e.: severe features, or conditions at the discretion of PI.
• Contraindications to neuraxial anesthesia, neuraxial morphine, acetaminophen, or NSAIDs which are standard parts of post-cesarean multimodal analgesia

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Grace Lim, MD, MS

OTHER

Sponsor Role: lead

Responsible Party

Grace Lim, MD, MS

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Grace Lim, MD MSc

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

Magee Women's Hospital of UPMC

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

STUDY21070164

Identifier Type: -

Identifier Source: org_study_id