Spinal Anesthesia With Articaine and Bupivacaine for Outpatient Lower Limb Surgery

Spinal Anesthesia Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Anesthesia

• NCT number: NCT00332735
• Study type: Interventional
• Source: Reinier de Graaf Groep
• Status: Completed
• Phase: Phase 3
• Start date: May 2006
• Completion date: January 2007