Spinal Anesthesia With Articaine and Bupivacaine for Outpatient Lower Limb Surgery
|ClinicalTrials.gov Identifier: NCT00332735|
Recruitment Status : Completed
First Posted : June 2, 2006
Last Update Posted : April 19, 2007
|Condition or disease||Intervention/treatment||Phase|
|Spinal Anesthesia||Drug: spinal administration of articaine Drug: spinal administration of bupivacaine||Phase 3|
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.
- onset of sensory and motor block
- maximum spread of sensory level
- recovery from sensory and motor block
- time to micturition
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Spinal Anesthesia With 5% Articaine and 0.5% Bupivacaine for Outpatient Lower Limb Surgery. A Double-Blind Randomised Clinical Trial|
|Study Start Date :||May 2006|
|Actual Study Completion Date :||January 2007|
- recovery time from motor blockade
- onset of sensory and motor blockade
- maximum spread of sensory blockade (30 min after spinal injection of anesthetic)
- spread of sensory blockade after 1,5 hour
- recovery time from sensory blockade
- time to micturation
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00332735
|Reinier de Graaf Groep|
|Voorburg, Zuid-Holland, Netherlands, 2275 CX|
|Principal Investigator:||Tessa Dijkstra, drs||Reinier de Graaf Groep|