Optimizing Anesthesia for Post Partum Tubal Ligations
Summary
In this study, the investigators will compare CLOROTEKAL® (1% spinal chloroprocaine) to low-dose isobaric bupivacaine using the epidural volume extension (EVE) technique in patients undergoing post-partum tubal ligation (PPBTL). This will be a randomized, double-blinded study. Patients scheduled for PPBTL at the Women and Infants Center (WIC) will be eligible for enrollment in this study. Outcomes measured will include: ability to achieve an adequate level required for surgery (T6), rate of epidural activation, and duration of the block. The investigators hope to determine the usefulness of each drug using the EVE technique in the setting of PPBTL.
Timeline
- Start
- 2019-08-13
- Primary completion
- 2020-12-03
- Completion
- 2020-12-03
Outcome
Missed primary endpoint
Stopped (Enrollment): “Lack of recruitment due to COVID-19 pandemic; chloroprocaine shortage”
registry analysis (superiority test); Bupivacaine vs Chloroprocaine; p = 0.757; Farrington-Manning (Score) test; note: Two-sided p-value NCT03993314 ↗
registry analysis (superiority test); Bupivacaine vs Chloroprocaine; p = 0.186; Wilcoxon (Mann-Whitney); note: Two-sided p-value NCT03993314 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bupivacaine | Other / unclassified | 5 mg | Intrathecal |
| Subject | Chloroprocaine | Other / unclassified | 50 mg | Intrathecal |
| Comparator | Fentanyl | Other / unclassified | 15 ug | Intrathecal |