Chloroprocaine Spinal Anesthesia for Cervical Cerclage (CP Spinal)

  • STATUS
    Not Recruiting
  • participants needed
    50
  • sponsor
    Columbia University
Updated on 26 January 2021

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.

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.

Details
Condition Adverse Reaction to Spinal Anesthetic, Maternal Care for Cervical Incompetence
Treatment Fentanyl, Saline, Bupivacaine, Chloroprocaine
Clinical Study IdentifierNCT02862912
SponsorColumbia University
Last Modified on26 January 2021

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