Status:
ACTIVE_NOT_RECRUITING
Stopping Opioid Overuse in Obstetrics to Halt Exposure Trial
Lead Sponsor:
University of Missouri, Kansas City
Collaborating Sponsors:
Truman Medical Center
Conditions:
Pain, Postoperative
Opioid Use
Eligibility:
FEMALE
18-45 years
Phase:
PHASE4
Brief Summary
As the opioid epidemic continues on, more research is needed on multi-modal approaches to decrease opioid exposure after common procedures. The aim of this study is to investigate the role of a transv...
Detailed Description
Nearly 1 in 3 women in the US deliver by cesarean delivery. After cesarean delivery, approximately 75-87% percent of women are discharged from the hospital with an opioid prescription. Most women fill...
Eligibility Criteria
Inclusion
- Unlabored, scheduled primary or repeat cesarean delivery
- Cesarean performed by obstetrician or surgically-trained family medicine physician
- Ability to complete numeric pain scale assessment and surveys
- Patients who do not speak English but are able to converse via an interpreter both in person and by phone
Exclusion
- Complications requiring return to the operating room
- Unscheduled deliveries
- \<18 years old, \>45 years old
- Twin deliveries
- Preterm deliveries (\<37 wks)
- Current or previous history of opioid-substance use disorder according to patient report or medical chart
- Prescription of opioid medication filled in previous 30 days prior to delivery according to patient report, documentation in electronic medical record, or documentation in the prescription drug monitoring program
- Allergy to local anesthetics or NSAIDs
- Cardiovascular disease, eg arrhythmia, or ASA (American Society of Anesthesiologists) Class III or higher
- Diagnosis of liver disorder or dysfunction including fatty liver of pregnancy, preeclampsia with severe features including liver or kidney involvement
- Known significant renal disease, oliguria, or Cr \>1.1.
- Platelet count less than or equal to 90k or rapid decline in third trimester or other coagulopathy
- Infection overlying the regional anesthesia site
- Hypovolemia prohibiting regional anesthesia
- General anesthesia
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT04680221
Start Date
March 1 2021
End Date
June 1 2025
Last Update
March 25 2025
Active Locations (1)
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1
Truman Medical Center - Lakewood
Kansas City, Missouri, United States, 64139