New York Presbyterian Hospital
New York, 10032, United States
NCT Number: NCT02862912
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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Notify Me18 year and older
Female
Interventional
Phase 4
New York, 10032, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Administered as a single injection or continuously through an indwelling catheter - 50 mg
Other names: Nesacaine
A dextrose Solution is usually given as an injection - 9 mg (1.4 ml)
Other names: Bupivacaine hydrochloride
15 mcg Fentanyl will be included int he spinal anesthetic in both groups
Other names: Sublimaze
Preservative free normal saline (0.3 ml) to bring the volume to ~ 2 ml
Other names: Salt water
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%)
Time frame: 5 hours
Time from spinal anesthesia placement to ability to ambulate.
Time frame: 5 hours
Time from spinal anesthesia injection to ability to void spontaneously.
Columbia University
Other
Chloroprocaine Versus Bupivacaine Spinal Anesthesia for Cervical Cerclage
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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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