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Comparison of Chloroprocaine vs Lidocaine for Epidural Anesthesia in Cesarean Delivery

NCT03414359 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2020-04-13

Study results available
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Summary

Regional anesthesia is commonly used for elective and emergency cesarean delivery. It provides numerous safety advantages when compared to general anesthesia for both the mother and fetus1. Epidurals also have the added benefit of being able to provide pain relief throughout labor and in the event of cesarean delivery, epidural analgesia can be "extended" to provide surgical anesthesia. Numerous studies have been performed to assess the onset times of various local anesthetics when administered through an epidural catheter. Attempts to reduce anesthetic onset time and improve the quality of intraoperative analgesia have been attempted by using different local anesthetic solutions and by the addition of other drugs to the epidural solution (such as epinephrine, fentanyl and sodium bicarbonate).

Conditions

  • Surgical Anesthesia, Cesarean Section

Interventions

DRUG

2% Lidocaine

2% Lidocaine using a combined spinal-epidural (CSE)

DRUG

3% Chloroprocaine

3% Chloroprocaine using a combined spinal-epidural (CSE)

Sponsors & Collaborators

  • University of Arkansas

    lead OTHER

Principal Investigators

  • Nadir Sharawi, MD · University of Arkansas

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-02-15
Primary Completion
2019-03-27
Completion
2019-03-27
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 NCT03414359 on ClinicalTrials.gov