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ED90 of 3% Chloroprocaine for Cervical Cerclage

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ClinicalTrials.gov Identifier: NCT03805438
Recruitment Status : Completed
First Posted : January 15, 2019
Results First Posted : September 1, 2021
Last Update Posted : October 12, 2021
Sponsor:
Collaborator:
University of Arkansas
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Cerclage, Cervical
Intervention Drug: Chloroprocaine Hcl 3% Inj
Enrollment 47
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Chloroprocaine Dose
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 47
Completed 45
Not Completed 2
Reason Not Completed
Lack of Efficacy             1
Protocol Violation             1
Arm/Group Title Chloroprocaine Dose
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 45
Hide Baseline Analysis Population Description
Participants who completed the study.
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 45 participants
32
(29 to 37)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants
Female
45
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants
Hispanic or Latino
4
   8.9%
Not Hispanic or Latino
41
  91.1%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants
American Indian or Alaska Native
0
   0.0%
Asian
3
   6.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
22
  48.9%
White
14
  31.1%
More than one race
0
   0.0%
Unknown or Not Reported
6
  13.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 45 participants
45
 100.0%
1.Primary Outcome
Title The Dose of Intrathecal (IT) Chloroprocaine That Provides Effective Anesthesia in 90% of Patients Undergoing Elective Cerclage Placement (Intraoperative Analgesic Supplementation Not Required).
Hide Description Identification of the dose of intrathecal 3% chloroprocaine that will provide adequate anesthesia for a cervical cerclage to occur.
Time Frame 60 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed the study.
Arm/Group Title Chloroprocaine Dose
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 45
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: mg
49.5
(45.0 to 50.1)
2.Secondary Outcome
Title Maximum Pain Numerical Pain Rating Scale (NPRS) During Surgery (as Reported by Patient, Scored From 0-10 in the PACU).
Hide Description The scale from 0-10 is used where a score of 0 represents no pain at all and a score of 10 represents the worst pain a participant could imagine. It is reported as a single score at a single point in time. No subscales are used.
Time Frame 60 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed the study.
Arm/Group Title Chloroprocaine Dose
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 45
Mean (Inter-Quartile Range)
Unit of Measure: score on a scale
0
(0 to 0)
3.Secondary Outcome
Title Number of Participants Who Reported Nausea (Self-reported by Patient, Yes or no).
Hide Description Number of participants reporting nausea.
Time Frame 60 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed the study.
Arm/Group Title Chloroprocaine Dose
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 45
Measure Type: Count of Participants
Unit of Measure: Participants
8
  17.8%
4.Secondary Outcome
Title Number of Participants With Observed Vomiting. (Observed Yes or no).
Hide Description Number of participants with observed vomiting.
Time Frame 60 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed the study.
Arm/Group Title Chloroprocaine Dose
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 45
Measure Type: Count of Participants
Unit of Measure: Participants
1
   2.2%
5.Secondary Outcome
Title Number of Participants Reporting Itching. (Self-reported by Patient, Yes or no).
Hide Description Number of participants reporting itching.
Time Frame 60 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Chloroprocaine Dose
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 45
Measure Type: Count of Participants
Unit of Measure: Participants
2
   4.4%
6.Secondary Outcome
Title Number of Patients Who Were Given Vasopressor Phenylephrine (and Ephedrine) BP Drops Greater Than 15% Below Baseline or < 100mg Hg Systolic.
Hide Description [Not Specified]
Time Frame 60 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed the study.
Arm/Group Title Chloroprocaine Dose
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 45
Measure Type: Count of Participants
Unit of Measure: Participants
13
  28.9%
7.Secondary Outcome
Title The Average Dose of Phenylephrine Given to Those Patients Whose BP Dropped Greater Than 15% Below Baseline or < 100mg Hg Systolic.
Hide Description All patients were analyzed for possible requirement of this intervention, though all participants did not require the intervention.
Time Frame 60 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed the study.
Arm/Group Title Chloroprocaine Dose
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 45
Mean (Inter-Quartile Range)
Unit of Measure: mg
320
(100 to 460)
8.Secondary Outcome
Title Overall Patient Satisfaction at Time of PACU Discharge.
Hide Description The scale used is 0-10 where 0 would represent completely unsatisfied and 10 would be completely satisfied. A 10 would imply that if a participant had to have the procedure performed again, it would be repeated in the exact same fashion it was carried out the first time. This will be assessed at the time of PACU discharge and will be asked one time. No subscales are used.
Time Frame 60 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed the study.
Arm/Group Title Chloroprocaine Dose
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 45
Mean (Inter-Quartile Range)
Unit of Measure: score on a scale
10
(10 to 10)
9.Secondary Outcome
Title Time to Resolution of Motor Block at End of the Cerclage Placement (Measured in the PACU).
Hide Description The motor block is assessed using the Bromage scale (1-5). The block is objectively assessed using this scale based on which joints a patient is able to mobilize following epidural or subarachnoid block. A score of 1 represents a patient who is unable to mobilize any lower extremity joint. A score of 5 represents a patient able to mobilize all lower extremity joints.
Time Frame 60 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed the study.
Arm/Group Title Chloroprocaine Dose
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 45
Mean (Inter-Quartile Range)
Unit of Measure: minutes
60
(45 to 90)
10.Secondary Outcome
Title Time to Hospital Discharge as Measured as the Time Difference Between Local Anesthetic Injection and Discharge Time as Recorded in the Medical Notes
Hide Description [Not Specified]
Time Frame approximately 180 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed the study.
Arm/Group Title Chloroprocaine Dose
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 45
Mean (Inter-Quartile Range)
Unit of Measure: minutes
150
(139 to 186)
11.Secondary Outcome
Title Time From Spinal Block to Ambulation
Hide Description [Not Specified]
Time Frame up to 180 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed the study.
Arm/Group Title Chloroprocaine Dose
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 45
Mean (Inter-Quartile Range)
Unit of Measure: minutes
60
(45 to 90)
12.Secondary Outcome
Title Time From Spinal Block to Micturition
Hide Description [Not Specified]
Time Frame approximately 180 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed the study.
Arm/Group Title Chloroprocaine Dose
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 45
Mean (Inter-Quartile Range)
Unit of Measure: minutes
150
(139 to 186)
13.Secondary Outcome
Title Time to Complete Sensory Regression
Hide Description [Not Specified]
Time Frame up to 180 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed the study.
Arm/Group Title Chloroprocaine Dose
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 45
Mean (Inter-Quartile Range)
Unit of Measure: minutes
90
(75 to 105)
14.Secondary Outcome
Title Time to Resolution of Motor Block (Bromage Score of 5)
Hide Description The motor block is assessed using the Bromage scale (1-5). The block is objectively assessed using this scale based on which joints a patient is able to mobilize following epidural or subarachnoid block. A score of 1 represents a patient who is unable to mobilize any lower extremity joint. A score of 5 represents a patient able to mobilize all lower extremity joints.
Time Frame up to 180 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed the study.
Arm/Group Title Chloroprocaine Dose
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 45
Mean (Inter-Quartile Range)
Unit of Measure: minutes
60
(45 to 90)
15.Secondary Outcome
Title Time to Readiness for PACU Discharge (Pre-defined Nursing Criteria)
Hide Description Readiness for PACU discharge would include a patient who is able to ambulate unassisted (indicating resolution of motor block), has vital signs within normal limits, has pain levels acceptable to the patient, and has been able to urinate.
Time Frame approximately 180 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed the study.
Arm/Group Title Chloroprocaine Dose
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 45
Mean (Inter-Quartile Range)
Unit of Measure: minutes
150
(139 to 186)
Time Frame Approximately 180 minutes
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Chloroprocaine Dose
Hide Arm/Group Description

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.

At the completion of this study, there were no adverse events experienced by any patients enrolled in the study. As such, the delineation of adverse events on a per dose level is unnecessary.

All-Cause Mortality
Chloroprocaine Dose
Affected / at Risk (%)
Total   0/47 (0.00%) 
Hide Serious Adverse Events
Chloroprocaine Dose
Affected / at Risk (%)
Total   0/47 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Chloroprocaine Dose
Affected / at Risk (%)
Total   0/47 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Riley Landreth, DO
Organization: Duke University
Phone: 919-684-8111
EMail: riley.landreth@duke.edu
Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03805438    
Other Study ID Numbers: Pro00100699
First Submitted: January 11, 2019
First Posted: January 15, 2019
Results First Submitted: August 5, 2021
Results First Posted: September 1, 2021
Last Update Posted: October 12, 2021