Status:
COMPLETED
Intrathecal Chloroprocaine vs. Bupivacaine for Cervical Cerclage
Lead Sponsor:
Tufts Medical Center
Conditions:
Cervical Incompetence
Eligibility:
FEMALE
18-45 years
Phase:
PHASE4
Brief Summary
This study aims to compare the effect of chloroprocaine vs. bupivacaine on duration of motor block and duration until meeting discharge criteria in patients undergoing cervical cerclage. The hypothesi...
Detailed Description
Cervical cerclage is an ambulatory surgical procedure of short duration commonly performed under spinal anesthesia. Bupivaciane and chlororpocaine are both commonly used, but how their use impacts cli...
Eligibility Criteria
Inclusion
- ASA classification II or III females
- Age: 18-45 years old
- BMI ≤ 50 kg/m2
- Singleton pregnancy
- Simple prophylactic cervical cerclage
- Planning neuraxial anesthesia
Exclusion
- Abdominal and complex cervical cerclage (e.g. bulging bag)
- Contraindication to neuraxial anesthesia
- Known hypersensitivity to chloroprocaine (a.k.a. Ester allergy), paraaminobenzoic acid (PABA) or bupivacaine (a.k.a. Amide allergy)
- Pseudocholinesterase deficiency
- Concomitant use with ergot-type oxytocic drugs
Key Trial Info
Start Date :
October 13 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 24 2018
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03305575
Start Date
October 13 2017
End Date
August 24 2018
Last Update
August 25 2020
Active Locations (1)
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1
Tufts Medical Center
Boston, Massachusetts, United States, 02111