Phase 4
N=43
Chloroprocaine Spinal Anesthesia for Cervical Cerclage (CP Spinal)
Adverse Reaction to Spinal Anesthetic · Maternal Care for Cervical Incompetence
Bottom Line
View on ClinicalTrials.gov: NCT02862912 ↗Enrolled (actual)
43
Serious AEs
0.0%
Results posted
May 2020
Primary outcome: Primary: Time to Resolution of Motor Block — 109; 112 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Chloroprocaine (Drug); Bupivacaine (Drug); Fentanyl (Drug); Saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Columbia University
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Resolution of Motor Block |
109; 112 | — |
| SECONDARY Time to Ambulate |
158; 229 | — |
| SECONDARY Time to Void |
229; 158 | — |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT02862912). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.