CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 47 enrolled
Drug / intervention
Chloroprocaine Hcl 3% Injdrug
Likely dose
Chloroprocaine Hcl 3% Inj 45mgfrom record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03805438
NCT03805438Phase 4Completed
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Determining the ED90 for Intrathecal 3% Chloroprocaine for Elective Cervical Cerclage Surgery

Duke University·interventional·Posted Jan 15, 2019·Updated Oct 12, 2021

In Brief

A Phase 4 clinical trial evaluating Chloroprocaine Hcl 3% Inj for Cerclage, Cervical. Completed, enrolled 47 participants across 2 sites.

Detailed Summary

The aim of this study is to identify the dose of intrathecal (IT) chloroprocaine that provides effective anesthesia in 90% of patients undergoing elective cerclage placement (intraoperative analgesic supplementation not required).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCerclage, Cervical
CountriesUnited States
CollaboratorsUniversity of Arkansas

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedJan 15, 2019
Enrollment StartFeb 7, 2019
Primary CompletionOct 23, 2020
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 7.5 years ago

Interventions

Chloroprocaine Hcl 3% Injdrug

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.