Chloroprocaine Spinal Anesthesia for Cervical Cerclage (CP Spinal)
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/6/2019 |
| Start Date: | November 8, 2016 |
| End Date: | December 31, 2020 |
| Contact: | Allison Lee, MD |
| Email: | al3196@columbia.edu |
Chloroprocaine Versus Bupivacaine Spinal Anesthesia for Cervical Cerclage
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.
chloroprocaine, wears off faster than the local anesthetic drug, bupivacaine, and results in
faster discharge from the post-anesthesia care unit after surgery.
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.
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.
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)
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