Status:
COMPLETED
Precision Opioid Care After Cesarean Delivery (PRECISE-CD)
Lead Sponsor:
Grace Lim, MD, MS
Conditions:
Cesarean Section Complications
Opioid Use
Eligibility:
FEMALE
18+ years
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 o...
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 p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 28 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2024
Estimated Enrollment :
341 Patients enrolled
Trial Details
Trial ID
NCT05280743
Start Date
March 28 2022
End Date
June 1 2024
Last Update
July 5 2024
Active Locations (1)
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1
Magee Women's Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213