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Minimum Effective Volume of Bupivacaine for Interscalene Block
NCT01244932Phase 2
Key facts
- Status
- Completed
- Start
- Sep 2009
- Primary completion
- Jun 2011
- Countries
- 1
- Sponsor
- Federal University of São Paulo
- Modality
- Small Molecules
- Drugs
- bupivacaine
- Conditions
- Anesthesia
01
Overview
Phase 2, double-blind, single-arm trial of bupivacaine in Anesthesia, sponsored by Federal University of São Paulo. Primary endpoint: ED95 of bupivacaine minimum effective volume. Started Sep 2009; status: completed.
02
Design
1 arm- Study design
- Non-randomizedDouble-blindSingle group
Bupivacaine Up-Down Sequence
Patients receive bupivacaine 0.5% for ISBPB. Volume starts at 15mL and is adjusted by 1mL based on success/failure of previous patient.
03
Who it enrols
Patients aged 21-65 undergoing shoulder surgery with ASA I/II and BMI < 35.
04
Endpoints
Primary
ED95 of bupivacaine minimum effective volume
Secondary
Diaphragmatic Function
Post-surgery analgesia
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