At a glance
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Chloroprocaine Lavage to Improve Outcomes Related to Operative Cesarean Delivery
In Brief
A Early Phase 1 clinical trial evaluating Preservative free 1% Chloroprocaine, Preservative free 2% Chloroprocaine, and 1 other intervention for Cesarean Section. Completed, enrolled 15 participants across 1 site.
Detailed 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 surgical pain, reduce complications, and improve the birth experience. The objectives in this study are to determine the amount of chloroprocaine that is absorbed into the blood in order to create a plasma concentration time profile and to determine the incidence of side effects to help guide selection of an appropriate concentration for future study.
Study Details
Timeline
Interventions
40 ml of preservative-free 1% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.
40 ml of preservative-free 2% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.
40 ml of preservative-free 3% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.