Status:
COMPLETED
Chloroprocaine Lavage to Improve Outcomes Related to Operative Cesarean Delivery
Lead Sponsor:
Oregon Health and Science University
Conditions:
Cesarean Section
Eligibility:
FEMALE
18-50 years
Phase:
EARLY_PHASE1
Brief Summary
The long term objective is to show that intraperitoneal chloroprocaine can be used an alternative option to avoid general anesthesia during cesarean delivery, to alleviate mother's discomfort from sur...
Detailed Description
Compared to general anesthesia, neuraxial anesthesia (spinals and epidurals) is associated with a lower risk for maternal aspiration and airway compromise, exposes the baby to less anesthetic, and all...
Eligibility Criteria
Inclusion
- Subjects ≥ 18 to 50 years of age having scheduled cesarean sections on 12C (Labor and Delivery) within Oregon Health \& Science University (OHSU).
- Only subjects having spinal anesthesia will be eligible.
- Only subjects that can have a Pfannenstiel incision will be enrolled.
Exclusion
- Subjects with chronic narcotic usage
- Subjects that are deemed to need a combined spinal epidural for any reason.
- Subjects who are unable to successfully get a spinal block
- Subjects with known atypical cholinesterase activity
- American Society of Anesthesiologist physical status IV or higher
- Subjects with contraindication to neuraxial anesthesia (coagulopathy, infection)
- Subjects with stage 4 chronic kidney disease or worse (eGFR \< 30 ml/min)
- Subjects with significant hepatic dysfunction (AST or ALT \> 2x the upper limit of normal)
- Subjects with allergies to drugs required for this protocol.
- Subjects with multifetal gestations
- Subjects with a BMI \> 40 kg/m2
Key Trial Info
Start Date :
September 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03760718
Start Date
September 30 2019
End Date
December 31 2021
Last Update
September 19 2024
Active Locations (1)
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1
OHSU Labor and Delivery; Oregon Health and Science University Hospital
Portland, Oregon, United States, 97239