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Heavy Levobupivacaine (S75:R25) vs Racemic Bupivacaine in Spinal Anesthesia for Lower Limb Fracture
NCT01308047Phase 3
Key facts
- Status
- Withdrawn
- Countries
- 1
- Sponsor
- Cristália
- Modality
- Small Molecules
- Drugs
- bupivacaine
01
Overview
Phase 3, randomised, double-blind trial of bupivacaine (2 arms), sponsored by Cristália. Primary endpoint: Time of latency for sensory block at T10 dermatome. Status: withdrawn.
02
Design
2 arms- Study design
- RandomizedDouble-blind
bupivacaine S75:R25
Heavy Levobupivacaine (S75:R25) 15mg (3ml)
bupivacaine (S50:R50)
Heavy Racemic Bupivacaine 15mg (3ml)
03
Who it enrols
Adult patients (ASA I or II) undergoing spinal anesthesia for lower limb surgery, excluding those with BMI >= 35, spinal contraindications, or history of hypersensitivity.
04
Endpoints
Primary
Time of latency for sensory block at T10 dermatome
Secondary
Sensory block duration
Motor Block Evaluation
Maximum cranial dispersion verifying the largest metamer achieved
Evaluation of the cardiocirculatory and respiratory parameters
Time of regression of motor block by Bromage Scale
The residual analgesic effect
Anesthetic failure
Adverse Events
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