Precision Opioid Care After Cesarean Delivery (PRECISE-CD)

Launched by GRACE LIM, MD, MS · Mar 6, 2022

Keywords

ClinConnect Summary

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 pat...

Gender

FEMALE

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