Phase 4
N=10
Intrathecal Chloroprocaine vs. Bupivacaine for Cervical Cerclage
Cervical Incompetence
Bottom Line
View on ClinicalTrials.gov: NCT03305575 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcome: Primary: Duration of Motor Block — 75; 99 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Chloroprocaine (Drug); Bupivacaine (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Tufts Medical Center
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Duration of Motor Block |
75; 99 | — |
| SECONDARY Duration of Sensory Block |
127; 210 | — |
| SECONDARY Time to Ambulation |
110; 179 | — |
| SECONDARY Time to Micturation |
111; 233 | — |
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 hypothesis is that chloroprocaine will result in faster resolution of motor block.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03305575). 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.