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Chloroprocaine Spinal Anesthesia for Cervical Cerclage (CP Spinal)

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ClinicalTrials.gov Identifier: NCT02862912
Recruitment Status : Recruiting
First Posted : August 11, 2016
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
Richard M. Smiley, Columbia University

Brief Summary:
This study aims to determine whether or not spinal anesthesia with the local anesthetic drug, chloroprocaine, wears off faster than the local anesthetic drug, bupivacaine, and results in faster discharge from the post-anesthesia care unit after surgery.

Condition or disease Intervention/treatment Phase
Adverse Reaction to Spinal Anesthetic Maternal Care for Cervical Incompetence Drug: Chloroprocaine Drug: Bupivacaine Drug: Fentanyl Drug: Saline Phase 4

Detailed Description:

This will be a prospective, randomized, double blind clinical trial. Subjects will be ASA I and II women ≥18 yrs old with a singleton pregnancy in the 1st or 2nd trimester of pregnancy undergoing cervical cerclage with spinal anesthesia. Patients will be randomly allocated to the chloroprocaine (CP) or bupivacaine group (BUP). Patients will receive spinal anesthesia with either chloroprocaine 50 mg with fentanyl 15 mcg or bupivacaine 9 mg with fentanyl 15 mcg.

Bupivacaine is the most common local anesthetic used for cervical cerclage with spinal anesthesia. Bupivacaine is safe and has been preferred over other medications such as lidocaine, because it is associated with a low incidence of a complication from spinal anesthesia known as "transient neurologic symptoms" - a condition where pain and cramping in the buttocks and lower extremities can be experienced for several days. Bupivacaine is a long-acting local anesthetic agent and therefore has the disadvantage of a prolonged anesthetic recovery that may last a few hours.

Chloroprocaine is a local anesthetic with a fast onset and short duration that may be used for spinal anesthesia for ambulatory procedures. Chloroprocaine is currently used at the research institution for spinal anesthesia for ambulatory surgical patients, especially for lower extremity orthopedic procedures such as knee arthroscopy, as well as for pregnant patients.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Chloroprocaine Versus Bupivacaine Spinal Anesthesia for Cervical Cerclage
Actual Study Start Date : November 8, 2016
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Chloroprocaine (CP)
Patients in CP group will receive 3% 2-chloroprocaine 50 mg (1.67 ml) and fentanyl 15 mcg (0.3 ml)
Drug: Chloroprocaine
Administered as a single injection or continuously through an indwelling catheter - 50 mg
Other Name: Nesacaine

Drug: Fentanyl
15 mcg Fentanyl will be included int he spinal anesthetic in both groups
Other Name: Sublimaze

Active Comparator: Bupivacaine (BUP)
Patients in BUP group will receive hyperbaric 0.75% bupivacaine 9 mg (1.4 ml), with fentanyl 15 mcg (0.3 ml), with saline (0.3 ml) to bring the volume to ~ 2 ml
Drug: Bupivacaine
A dextrose Solution is usually given as an injection - 9 mg (1.4 ml)
Other Name: Bupivacaine hydrochloride

Drug: Fentanyl
15 mcg Fentanyl will be included int he spinal anesthetic in both groups
Other Name: Sublimaze

Drug: Saline
Preservative free normal saline (0.3 ml) to bring the volume to ~ 2 ml
Other Name: Salt water




Primary Outcome Measures :
  1. Time to resolution of motor block [ Time Frame: 3 hours ]

    The mean difference between groups in time between the end of spinal injection (t IT) to time for no motor block (t motor), i.e. tIT - T motor. Motor block will be assessed using the Bromage scale:

    Bromage Scale I = free movement of the legs and feet = no block II = able to flex knees, with free movement of feet = partial (33%) block III = unable to flex knees, but with free movement of the feet = almost complete (66%) block IV = unable to move legs or feet = complete block (100%)



Secondary Outcome Measures :
  1. Time to ambulate [ Time Frame: 5 hours ]
    Time from spinal anesthesia placement to ability to ambulate.

  2. Time to void [ Time Frame: 5 hours ]
    Time from spinal anesthesia injection to ability to void spontaneously.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ASA I and II women
  • 18-45 yrs old
  • Singleton pregnancy
  • Cervical cerclage 1st or 2nd trimester of pregnancy undergoing with spinal anesthesia
  • Height 150 - 180 cm
  • BMI ≤ 40 kg/m2.

Exclusion Criteria:

  • Any contraindication to neuraxial anesthesia (history of neurologic disease (e.g., multiple sclerosis, spinal stenosis, central or peripheral neuropathy)
  • Pre-existing/chronic back pain
  • Ester local anesthetic allergy, PABA allergy
  • History of atypical cholinesterase (CP is metabolized by cholinesterase)

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): NCT02862912


Contacts
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Contact: Allison Lee, MD al3196@columbia.edu

Locations
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United States, New York
New York Presbyterian Hospital Recruiting
New York, New York, United States, 10032
Contact: Allison Lee, MD       al3196@columbia.edu   
Principal Investigator: Richard Smiley, MD         
Sponsors and Collaborators
Columbia University
Investigators
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Principal Investigator: Richard Smiley, MD Columbia University

Publications:
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Responsible Party: Richard M. Smiley, Professor of Anesthesiology, Columbia University
ClinicalTrials.gov Identifier: NCT02862912     History of Changes
Other Study ID Numbers: AAAQ0916
First Posted: August 11, 2016    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Richard M. Smiley, Columbia University:
Chloroprocaine
cervical cerclage
spinal anesthesia
Bupivacaine
Additional relevant MeSH terms:
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Uterine Cervical Incompetence
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Abortion, Habitual
Abortion, Spontaneous
Pregnancy Complications
Fentanyl
Anesthetics
Bupivacaine
Chloroprocaine
Procaine
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General