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ED90 of 3% Chloroprocaine for Cervical Cerclage

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ClinicalTrials.gov Identifier: NCT03805438
Recruitment Status : Recruiting
First Posted : January 15, 2019
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
University of Arkansas
Information provided by (Responsible Party):
Duke University

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).

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

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


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.





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 1-10 is used where a score of 1 represents minimal pain, but some perceptible pain. A score of 10 would represent the worst pain a participant could imagine. It is reported as a single score at a single point in time. No subscales are used.

  2. Nausea (self-reported by patient, yes or no). [ Time Frame: 60 minutes ]
  3. Vomiting (observed yes or no). [ Time Frame: 60 minutes ]
  4. Itching (self-reported by patient, yes or no). [ Time Frame: 60 minutes ]
  5. Proportion of patients who were given vasopressor phenylephrine (and ephedrine) BP drops greater than 15% below baseline or < 100mg Hg systolic. [ Time Frame: 60 minutes ]
  6. The average dose of phenylephrine given to patients whose BP dropped greater than 15% below baseline or < 100mg Hg systolic. [ Time Frame: 60 minutes ]
  7. 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.

  8. 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.

  9. 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: 180 minutes ]
  10. Time from spinal block to ambulation [ Time Frame: 180 minutes ]
  11. Time from spinal block to micturition [ Time Frame: 180 minutes ]
  12. Time to complete sensory regression [ Time Frame: 180 minutes ]
  13. Time to resolution of motor block (Bromage score of 0) [ Time Frame: 180 minutes ]
  14. Time to readiness for PACU discharge (pre-defined nursing criteria) [ Time Frame: 180 minutes ]


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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
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Cameron R Taylor, MD (919) 684-6633 cameron.r.taylor@duke.edu
Contact: Jennifer Dominguez, MD (919) 684-6633 jennifer.dominguez@duke.edu

Locations
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United States, Arkansas
University of Arkansas for Medical Sciences Not yet recruiting
Little Rock, Arkansas, United States, 72205
Contact: Nadir Sharawi, MD    501-686-6119    nelsharawi@uams.edu   
Contact: Jill Mhyre, MD    501-686-6119    jmmhyre@uams.edu   
United States, North Carolina
Duke University Hospital Recruiting
Durham, North Carolina, United States, 27710
Contact: Ashraf Habib, MBBS    919-684-6633    ashraf.habib@duke.edu   
Contact: Cameron R Taylor, MD    (919) 684-6633    cameron.r.taylor@duke.edu   
Principal Investigator: Ashraf Habib, MBBS         
Sub-Investigator: Cameron R Taylor, MD         
Sub-Investigator: Jennifer Dominguez, MD         
Sponsors and Collaborators
Duke University
University of Arkansas
Investigators
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Principal Investigator: Ashraf Habib, MBBS Duke University Hospital

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03805438     History of Changes
Other Study ID Numbers: Pro00100699
First Posted: January 15, 2019    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: January 2019
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.

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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
Additional relevant MeSH terms:
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Fentanyl
Chloroprocaine
Procaine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anesthetics, Local