NCT00332735

Spinal Anesthesia With Articaine and Bupivacaine for Outpatient Lower Limb Surgery

Spinal Anesthesia With 5% Articaine and 0.5% Bupivacaine for Outpatient Lower Limb Surgery. A Double-Blind Randomised Clinical Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (planned)
• Sponsor: Reinier de Graaf Groep · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the trial is to compare two local anesthetics, articaine and bupivacaine for outpatient lower limb surgery. Onset and recovery times of sensory and motor blockade will be compared.

Detailed description

The purpose of the trial is to compare two local anesthetics, articaine and bupivacaine for outpatient lower limb surgery. Faster onset and shorter elimination time favours a short-acting local anaesthetic for spinal anesthesia for out-patient lower limb surgery, e.g. knee arthroscopy, foot and varices surgery. Patients will recover faster and less complications will be expected. Articaine is said to act faster and shorter than a low dose of bupivacaine. There are not enough data available to establish that articaine is as safe as and more effective by outpatient lower limb surgery than bupivacaine. Spinal anesthesia with articaine will be compared to spinal anesthesia with bupivacaine in a randomized double blind clinical trial. Endpoints are: * onset of sensory and motor block * maximum spread of sensory level * recovery from sensory and motor block * time to micturition * complications

Conditions

• Spinal Anesthesia

Interventions

Type	Name	Description
DRUG	spinal administration of articaine
DRUG	spinal administration of bupivacaine

Timeline

• Start date: 2006-05-01
• Completion: 2007-01-01
• First posted: 2006-06-02
• Last updated: 2007-04-19

Locations

1 site across 1 country: Netherlands