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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cerclage, Cervical | Drug: Chloroprocaine Hcl 3% Inj | Phase 4 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 47 participants |
Allocation: | N/A |
Intervention Model: | Sequential Assignment |
Intervention Model 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. |
Masking: | None (Open Label) |
Masking Description: | 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. |
Primary Purpose: | Diagnostic |
Official Title: | Determining the ED90 for Intrathecal 3% Chloroprocaine for Elective Cervical Cerclage Surgery |
Actual Study Start Date : | February 7, 2019 |
Actual Primary Completion Date : | October 23, 2020 |
Actual Study Completion Date : | October 23, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Chloroprocaine dose
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
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. |
- The Dose of Intrathecal (IT) Chloroprocaine That Provides Effective Anesthesia in 90% of Patients Undergoing Elective Cerclage Placement (Intraoperative Analgesic Supplementation Not Required). [ Time Frame: 60 minutes ]Identification of the dose of intrathecal 3% chloroprocaine that will provide adequate anesthesia for a cervical cerclage to occur.
- Maximum Pain Numerical Pain Rating Scale (NPRS) During Surgery (as Reported by Patient, Scored From 0-10 in the PACU). [ Time Frame: 60 minutes ]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.
- Number of Participants Who Reported Nausea (Self-reported by Patient, Yes or no). [ Time Frame: 60 minutes ]Number of participants reporting nausea.
- Number of Participants With Observed Vomiting. (Observed Yes or no). [ Time Frame: 60 minutes ]Number of participants with observed vomiting.
- Number of Participants Reporting Itching. (Self-reported by Patient, Yes or no). [ Time Frame: 60 minutes ]Number of participants reporting itching.
- Number of Patients Who Were Given Vasopressor Phenylephrine (and Ephedrine) BP Drops Greater Than 15% Below Baseline or < 100mg Hg Systolic. [ Time Frame: 60 minutes ]
- The Average Dose of Phenylephrine Given to Those Patients Whose BP Dropped Greater Than 15% Below Baseline or < 100mg Hg Systolic. [ Time Frame: 60 minutes ]All patients were analyzed for possible requirement of this intervention, though all participants did not require the intervention.
- Overall Patient Satisfaction at Time of PACU Discharge. [ Time Frame: 60 minutes ]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 to Resolution of Motor Block at End of the Cerclage Placement (Measured in the PACU). [ Time Frame: 60 minutes ]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 to Hospital Discharge as Measured as the Time Difference Between Local Anesthetic Injection and Discharge Time as Recorded in the Medical Notes [ Time Frame: approximately 180 minutes ]
- Time From Spinal Block to Ambulation [ Time Frame: up to 180 minutes ]
- Time From Spinal Block to Micturition [ Time Frame: approximately 180 minutes ]
- Time to Complete Sensory Regression [ Time Frame: up to 180 minutes ]
- Time to Resolution of Motor Block (Bromage Score of 5) [ Time Frame: up to 180 minutes ]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 to Readiness for PACU Discharge (Pre-defined Nursing Criteria) [ Time Frame: approximately 180 minutes ]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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- ≥ 18 years of age
- Singleton pregnancy
- ASA class II or III
- Cervical cerclage 1st or 2nd trimester of pregnancy
- Simple prophylactic cervical cerclage
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03805438
United States, Arkansas | |
University of Arkansas for Medical Sciences | |
Little Rock, Arkansas, United States, 72205 | |
United States, North Carolina | |
Duke University Hospital | |
Durham, North Carolina, United States, 27710 |
Principal Investigator: | Ashraf Habib, MBBS | Duke University Hospital |
Documents provided by Duke University:
Responsible Party: | Duke University |
ClinicalTrials.gov Identifier: | NCT03805438 |
Other Study ID Numbers: |
Pro00100699 |
First Posted: | January 15, 2019 Key Record Dates |
Results First Posted: | September 1, 2021 |
Last Update Posted: | October 12, 2021 |
Last Verified: | October 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | 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. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (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. |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Chloroprocaine Anesthetics, Local Anesthetics Central Nervous System Depressants |
Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents |