NCT03414359

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 29, 2018

Completed
17 days until next milestone

Study Start

First participant enrolled

February 15, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2019

Completed
1 year until next milestone

Results Posted

Study results publicly available

April 13, 2020

Completed
Last Updated

April 13, 2020

Status Verified

March 1, 2020

Enrollment Period

1.1 years

First QC Date

January 22, 2018

Results QC Date

February 12, 2020

Last Update Submit

March 30, 2020

Conditions

Surgical Anesthesia, Cesarean Section

Outcome Measures

Primary Outcomes (1)

  • The Onset Time to Surgical Anesthesia

    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.

    Up to 35 minutes

Secondary Outcomes (1)

  • Secondary Outcome: Number of Participants With Requirement for Intraoperative Analgesia Supplementation

    1 hour

Study Arms (2)

2% Lidocaine

ACTIVE COMPARATOR

Group LEBF received 20 ml of 2% lidocaine (combined with the following adjuncts \[0.15 ml of 0.1% epinephrine, 2 ml of 8.4% sodium bicarbonate and 2 ml of 100 mcg fentanyl

Drug: 2% Lidocaine

3% Chloroprocaine

EXPERIMENTAL

20 ml of 3% chloroprocaine with 4 ml 0.9% sodium chloride

Drug: 3% Chloroprocaine

Interventions

2% LidocaineDRUG

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

Also known as: Xylocaine
2% Lidocaine
3% ChloroprocaineDRUG

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

Also known as: Nesacaine
3% Chloroprocaine

Eligibility Criteria

Age18 Years - 99 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsAny mother requiring an elective cesarean section.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 18 years of age for the mother
  • Singleton pregnancy
  • Gestation \> 36 weeks
  • American Society of Anesthesiologist (ASA) class II
  • Provides written consent
  • Infant of mother

You may not qualify if:

  • Patient refusal
  • Non-elective or urgent/emergent cesarean sections
  • ASA class III or above
  • Unable to understand English
  • Significant back surgery or scoliosis
  • Known fetal abnormality
  • Weight \> 120 kg
  • Height \< 150 cm
  • Allergy to local anesthetics
  • Concurrent use of sulfonamides

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Related Publications (1)

  • Sharawi N, Bansal P, Williams M, Spencer H, Mhyre JM. Comparison of Chloroprocaine Versus Lidocaine With Epinephrine, Sodium Bicarbonate, and Fentanyl for Epidural Extension Anesthesia in Elective Cesarean Delivery: A Randomized, Triple-Blind, Noninferiority Study. Anesth Analg. 2021 Mar 1;132(3):666-675. doi: 10.1213/ANE.0000000000005141.

    PMID: 32852294DERIVED

MeSH Terms

Interventions

Lidocainechloroprocaine

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Results Point of Contact

Title
Nadir El Sharawi
Organization
UAMS
nelsharawi@uams.edu
5016866114

Study Officials

  • Nadir Sharawi, MD

    University of Arkansas

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2018

First Posted

January 29, 2018

Study Start

February 15, 2018

Primary Completion

March 27, 2019

Study Completion

March 27, 2019

Last Updated

April 13, 2020

Results First Posted

April 13, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)