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Completed

NCT Number: NCT02862912

Chloroprocaine Spinal Anesthesia for Cervical Cerclage (CP Spinal)

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

New York Presbyterian Hospital

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Chloroprocaine

Drug

Administered as a single injection or continuously through an indwelling catheter - 50 mg

Other names: Nesacaine

Bupivacaine

Drug

A dextrose Solution is usually given as an injection - 9 mg (1.4 ml)

Other names: Bupivacaine hydrochloride

Fentanyl

Drug

15 mcg Fentanyl will be included int he spinal anesthetic in both groups

Other names: Sublimaze

Saline

Drug

Preservative free normal saline (0.3 ml) to bring the volume to ~ 2 ml

Other names: Salt water

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

Chloroprocaine Versus Bupivacaine Spinal Anesthesia for Cervical Cerclage

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Aug 11, 2016
Registry last updated
Dec 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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