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Chloroprocaine Spinal Anesthesia for Cervical Cerclage (CP Spinal)

Phase 4
Completed
Conditions
Maternal Care for Cervical Incompetence
Adverse Reaction to Spinal Anesthetic
Interventions
Registration Number
NCT02862912
Lead Sponsor
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
43
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)

Study & Design

Study Type
INTERVENTIONAL
Study Design
FACTORIAL
Arm && Interventions
GroupInterventionDescription
Chloroprocaine (CP)FentanylPatients in CP group will receive 3% 2-chloroprocaine 50 mg (1.67 ml) and fentanyl 15 mcg (0.3 ml)
Bupivacaine (BUP)SalinePatients 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
Chloroprocaine (CP)ChloroprocainePatients in CP group will receive 3% 2-chloroprocaine 50 mg (1.67 ml) and fentanyl 15 mcg (0.3 ml)
Bupivacaine (BUP)FentanylPatients 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
Bupivacaine (BUP)BupivacainePatients 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
Primary Outcome Measures
NameTimeMethod
Time to Resolution of Motor Block3 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
NameTimeMethod
Time to Ambulate5 hours

Time from spinal anesthesia placement to ability to ambulate.

Time to Void5 hours

Time from spinal anesthesia injection to ability to void spontaneously.

Trial Locations

Locations (1)

New York Presbyterian Hospital

🇺🇸

New York, New York, United States

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