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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00332735

Enrollment

Registered

2006-06-02

Start date

2006-05-31

Completion date

2007-01-31

Last updated

2007-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Anesthesia

Keywords

spinal, anesthesia, articaine, bupivacaine, outpatient, surgery, limbs

Brief 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

Interventions

DRUGspinal administration of articaine

DRUGspinal administration of bupivacaine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Age between 18 and 70 years * Patients planned for an outpatient lower limb surgery * Procedure under spinal anesthesia * Informed consent

Exclusion criteria

* Contra-indications spinal anesthesia * History of allergic reactions on amide-type local anesthetics * Length \< 1.60 m or \> 1.90 m * BMI \< 18.5 kg/m2 or \> 35 kg/m2 * Pregnancy

Design outcomes

Primary

Measure	Time frame
recovery time from motor blockade	—

Secondary

Measure	Time frame
time to micturation	—
complications	—
recovery time from sensory blockade	—
maximum spread of sensory blockade (30 min after spinal injection of anesthetic)	—
spread of sensory blockade after 1,5 hour	—
onset of sensory and motor blockade	—

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026