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Chloroprocaine Lavage to Improve Outcomes Related to Operative Cesarean Delivery

NCT03760718 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-09-19

Study results available
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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.

Conditions

  • Cesarean Section

Interventions

DRUG

Preservative free 1% Chloroprocaine

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

DRUG

Preservative free 2% Chloroprocaine

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

DRUG

Preservative free 3% Chloroprocaine

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

Sponsors & Collaborators

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

  • Brandon M Togioka, MD · Oregon Health and Science University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-30
Primary Completion
2020-09-17
Completion
2021-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03760718 on ClinicalTrials.gov