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Lidocaine-Prilocaine Cream for Axillary Block Puncture Pain
NCT01673542Phase 2
Key facts
- Status
- Completed
- Start
- Aug 2012
- Primary completion
- May 2013
- Countries
- 1
- Sponsor
- CHU de Poitiers
- Modality
- Small Molecules, Drug Delivery Systems
- Conditions
- procedural pain
01
Overview
Phase 2, randomised, double-blind trial of lidocaine + prilocaine in procedural pain (2 arms), sponsored by CHU de Poitiers. Primary endpoint: Visual Analog Scale. Started Aug 2012; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Lidocaine-Prilocaine 5%
Application of Lidocaine-Prilocaine 5% cream
Dexeryl
Application of Dexeryl placebo cream
03
Who it enrols
Adult patients (>= 18 years) hospitalized for scheduled upper extremity surgery requiring axillary block anesthesia. Excludes patients with hypersensitivity to amides/excipients, methemoglobinemia, porphyrias, G6PD deficiency, uncontrolled epilepsy, skin infections at puncture site, psychiatric disorders, severe heart failure, or those on anticoagulants.
04
Endpoints
Primary
Visual Analog Scale
Secondary
Pain Evaluation
Patient Satisfaction
Procedural Success
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