NCT03414359

Comparison of Chloroprocaine vs Lidocaine for Epidural Anesthesia in Cesarean Delivery

Completed EARLY_PHASE1 Results posted Last updated 13 April 2020

What this trial tests

EARLY_PHASE1 trial testing 2% Lidocaine in Surgical Anesthesia, Cesarean Section in 70 participants. Completed in 27 March 2019.

Timeline

15 February 2018

Primary endpoint
27 March 2019

27 March 2019

Quick facts

Lead sponsor	University of Arkansas
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	70
Start date	15 February 2018
Primary completion	27 March 2019
Estimated completion	27 March 2019
Sites	1 location across United States

Drugs / interventions tested

• 2% Lidocaine
• 3% Chloroprocaine — full drug profile →

Conditions studied

• Surgical Anesthesia, Cesarean Section — all drugs for Surgical Anesthesia, Cesarean Section →

Sponsor

University of Arkansas

Who can join

Adults 18 to 99, female only, with Surgical Anesthesia, Cesarean Section. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

The Onset Time to Surgical Anesthesia Primary · Up to 35 minutes

The onset time to surgical anesthesia, as reported by the participant using a standard procedure This will be measured by the time taken from the end of the epidural loading dose to develop a loss of touch sensation using a neurotip® (Owen Mumford, USA) device bilaterally at the T7 dermatomal level using a non-inferiority study design. A non-inferiority limit of 3 minutes was chosen apriori.

Group	Value	95% CI
2% Lidocaine	558	± 269
3% Chloroprocaine	655	± 258

Secondary Outcome: Number of Participants With Requirement for Intraoperative Analgesia Supplementation Secondary · 1 hour

This requirement for any rescue medications to control discomfort or pain during CD

Group	Value	95% CI
2% Lidocaine	4
3% Chloroprocaine	7

Adverse events — posted to ClinicalTrials.gov

Time frame: During inpatient admission, approximately three days. Reporting threshold: 3%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

2% Lidocaine

Serious: 0/34 (0%)

Deaths: 0/34

3% Chloroprocaine

Serious: 0/33 (0%)

Deaths: 0/33

Other adverse events (1 terms — click to expand)

Reaction	System	2% Lidocaine	3% Chloroprocaine
Post dural puncture headache	Nervous system disorders	—	—

Data from ClinicalTrials.gov NCT03414359 adverse events section.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.