ED90 of 3% Chloroprocaine for Cervical Cerclage

PHASE4CompletedINTERVENTIONAL
Enrollment

47

Participants

Timeline

Start Date

February 7, 2019

Primary Completion Date

October 23, 2020

Study Completion Date

October 23, 2020

Conditions
Cerclage, Cervical
Interventions
DRUG

Chloroprocaine Hcl 3% Inj

"Initial Patient (A#X) 45mg (1.5mL) of Chloroprocaine 3% (Nesacaine - Fresenius Kabi), will be drawn up into a 3 ml syringe (a 1 ml 'TB syringe' will be used to aspirate the drug in aliquots to ensure accuracy). The following additive will be added: 10 mcg (0.2ml) of fentanyl (50 mcg/ml) 0.3 ml of sterile 0.9% sodium chloride Thus the total volume in the syringe will be 2 ml. Study drugs will be prepared by one anesthesiologist (un-blinded) and administered by another anesthesiologist (blinded).~Subsequent Patient (A#X+1) The dose of Chloroprocaine 3% based on outcome from prior subject and calculations mentioned previously will be added to 10 mcg (0.2ml) of fentanyl (50 mcg/ml). Sterile 0.9% sodium chloride will be added until the total volume in the syringe is 2 ml."

Trial Locations (2)

27710

Duke University Hospital, Durham

72205

University of Arkansas for Medical Sciences, Little Rock

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

University of Arkansas

OTHER

lead

Duke University

OTHER

NCT03805438 - ED90 of 3% Chloroprocaine for Cervical Cerclage | Biotech Hunter | Biotech Hunter