Spinal Anesthesia With Articaine and Lidocaine for Outpatient Surgery.
Information source: St. Antonius Hospital
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Spinal Anesthesia
Intervention: spinal administration of articaine (Drug); spinal administration of lidocaine (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: St. Antonius Hospital Official(s) and/or principal investigator(s):
Leon Timmerman, MD, Principal Investigator, Affiliation: St Antonius Hospital, dept. of anesthesiology
Emile MJ Andriessen, MD, Study Chair, Affiliation: St Antonius Hospital, dept of anesthesiology
Summary
The purpose of this study is to compare two short-acting local anesthetics, articaine and
lidocaine, for spinal anesthesia in day-case surgery. The onset time of the sensory- and
motor block, recovery time until discharge and complications will be studied.
Clinical Details
Official title: Spinal Anesthesia With Articaine and Lidocaine for Outpatient Surgery: A Double Blind Randomized Clinical Trial.
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Onset time (sec) of sensory and motor blockade (after administration of drug)Recovery time (min) from sensory and motor blockade Spread of sensory blockade (30 min after administration of drug, dermatomal level)
Secondary outcome: Hemodynamic stability (lowest systolic blood pressure, vasopressor therapy)Complications Patient satisfaction
Detailed description:
The ideal spinal anesthesia in day-case surgery is characterized by a short onset of sensory
and motor blockade, and a rapid recovery after the operation. Short-acting local-anesthetics
are used frequently in this setting.
Lidocaine is one of the agents that is used most frequently. It has been associated with an
increased incidence of Transient Neurological Symptoms (TNS). Articaine is another agent that
is being used more often and is said to act faster and shorter than lidocaine.
We will compare spinal anesthesia with lidocaine and articaine in a randomized double-blind
clinical trial. Endpoint are:
- onset of sensory and motor block
- recovery from sensory and motor block
- time to micturition
- patient satisfaction
- complications
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Age > 18 years
- ASA I-III
- Patients planned for a short surgical procedure on lower extremities or lower
abdomen.
- Procedure in day-case setting
- Procedure under spinal anesthesia
- Informed consent
Exclusion Criteria:
- Contra-indications spinal anesthesia
- History of allergic reactions on amide-type local anesthetics
- Pregnancy
Locations and Contacts
St Antonius Hospital, Nieuwegein, Utrecht 3435 CM, Netherlands
Additional Information
Related publications: Vree TB, Gielen MJ. Clinical pharmacology and the use of articaine for local and regional anaesthesia. Best Pract Res Clin Anaesthesiol. 2005 Jun;19(2):293-308. Review.
Starting date: November 2005
Ending date: May 2006
Last updated: May 15, 2006
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