Precision Opioid Care After Cesarean Delivery (PRECISE-CD)

NCT05280743 | Completed FDA Drug

• 1 other identifier: STUDY21070164
• Study Type: observational
• Target: 341
• Locations: 1 country
• Sites: 1

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.

Conditions

Cesarean Section Complications; Opioid Use

Keywords

Personalized Care

Outcome Measures

Primary Outcomes (2)

• Opioid-Induced Adverse Effects-PROPORTION of maternal participants with RD

  Respiratory depression (RD) measured as Yes or No in occurrence.

  From time of surgery to time of discharge up to 3 days post-surgery

• Opioid-Induced Adverse Effects-PROPORTION of maternal participants with PONV

  Postoperative Nausea and Vomiting (PONV) Intensity Scale. Participants will be categorized as Clinically relevant (Yes) or Not clinically relevant (No) Nausea and Vomiting from the PONV scale. Clinically important PONV is defined as a total score \>50 at any time throughout the study period.

  From time of surgery to time of discharge up to 3 days post-surgery

Secondary Outcomes (9)

• Maternal Post-operative Pain Scores

  From time of delivery to 12-month post-surgery

• Total Maternal Inpatient Opioid Use

  From time of surgery to discharge-- up to 3 days post-surgery

• Extended Hospital Length of Stay-Maternal

  From surgery to 72 hours postoperation

• Length of prescribed opioid use (For Mothers; in days)

  From day of surgery to 12-month post-surgery

• Neonatal Sedation-- PROPORTION of infants with Sedation

  From birth to 7-days post-birth

Study Arms (2)

MATERNAL cohort

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

Drug: Oxycodone

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.

Drug: Oxycodone

Interventions

Oxycodone DRUG

exposure to opioids after Cesarean Section

Also known as: Opioid Exposure

MATERNAL cohort; NEONATE-INFANT cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants who have Cesarean Delivery and who plan to breast feed their infants

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Grace Lim, MD, MS: lead

Study Sites (1)

Magee Women's Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Pharmacogenetic (PG) Blood Samples: A blood sample will be collected to assess polymorphisms of genotypes, epigenetics, and gene expression affecting opioid effectiveness, metabolism and transport. CYP2D6 genotyping will be utilized to characterize CYP2D6 Poor Metabolizers (PMs) and Ultrarapid Metabolizers (UMS). Polymorphisms of OPRM1, COMT, and GCH1 have been associated with intensity and chronicity of post-surgical pain. The Illumina Human Omni5M+exome GWAS array (4.3 million SNPs) or equivalent GWAS panel will help us explore additional genetic variants while allowing unbiased exploration of additional154 biologically relevant genetic variants cost-effectively in all study participants.

MeSH Terms

Interventions

Oxycodone

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Grace Lim, MD MSc

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 6, 2022
• First Posted: March 15, 2022
• Study Start: March 28, 2022
• Primary Completion: September 24, 2023
• Study Completion: June 1, 2024
• Last Updated: July 5, 2024

Record last verified: 2024-07

Locations

US (1)