NCT03805438

Brief 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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

2 active sites

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 11, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 15, 2019

Completed
23 days until next milestone

Study Start

First participant enrolled

February 7, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 23, 2020

Completed
10 months until next milestone

Results Posted

Study results publicly available

September 1, 2021

Completed
Last Updated

October 12, 2021

Status Verified

October 1, 2021

Enrollment Period

1.7 years

First QC Date

January 11, 2019

Results QC Date

August 5, 2021

Last Update Submit

October 7, 2021

Conditions

Cerclage, Cervical

Outcome Measures

Primary Outcomes (1)

  • The Dose of Intrathecal (IT) Chloroprocaine That Provides Effective Anesthesia in 90% of Patients Undergoing Elective Cerclage Placement (Intraoperative Analgesic Supplementation Not Required).

    Identification of the dose of intrathecal 3% chloroprocaine that will provide adequate anesthesia for a cervical cerclage to occur.

    60 minutes

Secondary Outcomes (14)

  • Maximum Pain Numerical Pain Rating Scale (NPRS) During Surgery (as Reported by Patient, Scored From 0-10 in the PACU).

    60 minutes

  • Number of Participants Who Reported Nausea (Self-reported by Patient, Yes or no).

    60 minutes

  • Number of Participants With Observed Vomiting. (Observed Yes or no).

    60 minutes

  • Number of Participants Reporting Itching. (Self-reported by Patient, Yes or no).

    60 minutes

  • Number of Patients Who Were Given Vasopressor Phenylephrine (and Ephedrine) BP Drops Greater Than 15% Below Baseline or < 100mg Hg Systolic.

    60 minutes

  • +9 more secondary outcomes

Study Arms (1)

Chloroprocaine dose

EXPERIMENTAL

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.

Drug: Chloroprocaine Hcl 3% Inj

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.

Chloroprocaine dose

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 18 years of age
  • Singleton pregnancy
  • ASA class II or III
  • Cervical cerclage 1st or 2nd trimester of pregnancy
  • Simple prophylactic cervical cerclage

You may not qualify if:

  • Patient refusal
  • Abdominal and complex cervical cerclage (e.g. bulging bag)
  • BMI ≥ 50 kg/m2
  • ASA class IV or above
  • Contraindication to neuraxial anesthesia
  • Allergy to chloroprocaine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Duke University Hospital

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

  • Sharawi N, Tan HS, Taylor C, Fuller ME, Landreth RA, Diomede OI, Williams M, Martinello C, Mhyre JM, Habib AS. ED 90 of Intrathecal Chloroprocaine With Fentanyl for Prophylactic Cervical Cerclage: A Sequential Allocation Biased-Coin Design. Anesth Analg. 2022 Apr 1;134(4):834-842. doi: 10.1213/ANE.0000000000005927.

    PMID: 35139044DERIVED

MeSH Terms

Interventions

chloroprocaine

Results Point of Contact

Title
Riley Landreth, DO
Organization
Duke University
riley.landreth@duke.edu
919-684-8111

Study Officials

  • Ashraf Habib, MBBS

    Duke University Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Masking Details
The solutions and their administration procedures are identical to those used outside this research and are almost exclusively used for patients requiring spinal anesthesia for cervical cerclage. The only deviation involves diluting the chloroprocaine with saline so that study solutions are of equal volume to maintain blinding.
Purpose
DIAGNOSTIC
Intervention Model
SEQUENTIAL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2019

First Posted

January 15, 2019

Study Start

February 7, 2019

Primary Completion

October 23, 2020

Study Completion

October 23, 2020

Last Updated

October 12, 2021

Results First Posted

September 1, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will share

IPD will be shared between institutions insofar as it is required for the sequential study design when evaluating the primary outcome. The dose of chloroprocaine used for each procedure as well as the outcome of the surgery will dictate the dosing for the next patient at either institution. PHI will not be shared however.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
The study protocol will be shared between institutions and will be identical. The SAP, CSR, and analytic code is also shared and identical. The ICF however will be different and each institution will use its own version of the consent form.
Access Criteria
Shared data will be stored in REDCap to be used between institutions. The data will be shared by the PIs and all members listed on the Duke IRB submission both at Duke and UAMS. All statistical analyses will be done at Duke.

Locations

US(2)