ED90 of 3% Chloroprocaine for Cervical Cerclage

• 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: Duke University
• 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

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Chloroprocaine Dose
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

Baseline Characteristics

Arm/Group Title		Chloroprocaine Dose
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
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%

Outcome Measures

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).
Description	Identification of the dose of intrathecal 3% chloroprocaine that will provide adequate anesthesia for a cervical cerclage to occur.
Time Frame	60 minutes

Outcome Measure Data

Analysis Population Description

Participants who completed the study.

Arm/Group Title	Chloroprocaine Dose
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).
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

Outcome Measure Data

Analysis Population Description

Participants who completed the study.

Arm/Group Title	Chloroprocaine Dose
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).
Description	Number of participants reporting nausea.
Time Frame	60 minutes

Outcome Measure Data

Analysis Population Description

Participants who completed the study.

Arm/Group Title	Chloroprocaine Dose
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).
Description	Number of participants with observed vomiting.
Time Frame	60 minutes

Outcome Measure Data

Analysis Population Description

Participants who completed the study.

Arm/Group Title	Chloroprocaine Dose
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).
Description	Number of participants reporting itching.
Time Frame	60 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Chloroprocaine Dose
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.
Description	[Not Specified]
Time Frame	60 minutes

Outcome Measure Data

Analysis Population Description

Participants who completed the study.

Arm/Group Title	Chloroprocaine Dose
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.
Description	All patients were analyzed for possible requirement of this intervention, though all participants did not require the intervention.
Time Frame	60 minutes

Outcome Measure Data

Analysis Population Description

Participants who completed the study.

Arm/Group Title	Chloroprocaine Dose
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.
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

Outcome Measure Data

Analysis Population Description

Participants who completed the study.

Arm/Group Title	Chloroprocaine Dose
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).
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

Outcome Measure Data

Analysis Population Description

Participants who completed the study.

Arm/Group Title	Chloroprocaine Dose
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
Description	[Not Specified]
Time Frame	approximately 180 minutes

Outcome Measure Data

Analysis Population Description

Participants who completed the study.

Arm/Group Title	Chloroprocaine Dose
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
Description	[Not Specified]
Time Frame	up to 180 minutes

Outcome Measure Data

Analysis Population Description

Participants who completed the study.

Arm/Group Title	Chloroprocaine Dose
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
Description	[Not Specified]
Time Frame	approximately 180 minutes

Outcome Measure Data

Analysis Population Description

Participants who completed the study.

Arm/Group Title	Chloroprocaine Dose
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
Description	[Not Specified]
Time Frame	up to 180 minutes

Outcome Measure Data

Analysis Population Description

Participants who completed the study.

Arm/Group Title	Chloroprocaine Dose
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)
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

Outcome Measure Data

Analysis Population Description

Participants who completed the study.

Arm/Group Title	Chloroprocaine Dose
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)
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

Outcome Measure Data

Analysis Population Description

Participants who completed the study.

Arm/Group Title	Chloroprocaine Dose
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)

Adverse Events

Time Frame	Approximately 180 minutes
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Chloroprocaine Dose
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%)
Serious Adverse Events
	Chloroprocaine Dose
	Affected / at Risk (%)
Total	0/47 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Chloroprocaine Dose
	Affected / at Risk (%)
Total	0/47 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Riley Landreth, DO
• Organization: Duke University
• Phone: 919-684-8111
• EMail: riley.landreth@duke.edu

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• 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