drugset / Trial / NCT01994967
Phase III, Evaluate Noninferiority Between Levobupivacaine and Bupivacaine in Spinal Anesthesia.
Phase 3
Withdrawn
Cristália Produtos Químicos Farmacêuticos Ltda.
Newco Trials Pesquisa Científica Ltda · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
Clinical trial phase III, noninferiority, controlled, double-blind, randomized. The purpose of this study is to evaluate the noninferiority between Levobupivacaine and Bupivacaine in spinal anesthesia.
Timeline
- Start
- 2016-11
- Primary completion
- 2016-12
- Completion
- 2017-01
Outcome
Outcome not reported
Stopped: “Another regulatory way was defined.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bupivacaine | Other / unclassified | 3 ml | Intrathecal |
| Subject | Levobupivacaine | Other / unclassified | 3 ml | Intrathecal |
| Background | Morphine | Other / unclassified | — | Intrathecal |