CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 15 enrolled
Drug / intervention
Preservative free 1% Chloroprocaine +2 moredrug
Likely dose
Preservative free 1% Chloroprocaine 40 mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03760718
NCT03760718Early Ph 1Completed

Chloroprocaine Lavage to Improve Outcomes Related to Operative Cesarean Delivery

Oregon Health and Science University·interventional·Posted Nov 30, 2018·Updated Sep 19, 2024

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Early Ph 1CompletedFinished
20192020202120222023202420252026
First PostedNov 30, 2018
Enrollment StartSep 30, 2019
Primary CompletionSep 17, 2020
Study CompletionDec 31, 2021
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 7.6 years ago

Interventions

Preservative free 1% Chloroprocainedrug

40 ml of preservative-free 1% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.

Preservative free 2% Chloroprocainedrug

40 ml of preservative-free 2% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.

Preservative free 3% Chloroprocainedrug

40 ml of preservative-free 3% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.