Spinal Anesthesia With Articaine and Lidocaine for Outpatient Surgery.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00247741
Recruitment Status : Completed
First Posted : November 2, 2005
Last Update Posted : December 19, 2013
Information provided by:
St. Antonius Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Spinal Anesthesia Drug: spinal administration of articaine Drug: spinal administration of lidocaine Phase 3

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

Study Type : Interventional  (Clinical Trial)
Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Spinal Anesthesia With Articaine and Lidocaine for Outpatient Surgery: A Double Blind Randomized Clinical Trial.
Study Start Date : November 2005
Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia

Arm Intervention/treatment
Active Comparator: lidocaine Drug: spinal administration of lidocaine
Experimental: articaine Drug: spinal administration of articaine

Primary Outcome Measures :
  1. Onset time (sec) of sensory and motor blockade (after administration of drug)
  2. Recovery time (min) from sensory and motor blockade
  3. Spread of sensory blockade (30 min after administration of drug, dermatomal level)

Secondary Outcome Measures :
  1. Hemodynamic stability (lowest systolic blood pressure, vasopressor therapy)
  2. Complications
  3. Patient satisfaction

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age > 18 years
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00247741

St Antonius Hospital
Nieuwegein, Utrecht, Netherlands, 3435 CM
Sponsors and Collaborators
St. Antonius Hospital
Principal Investigator: Leon Timmerman, MD St Antonius Hospital, dept. of anesthesiology
Study Chair: Emile MJ Andriessen, MD St Antonius Hospital, dept of anesthesiology

Publications of Results:
Other Publications: Identifier: NCT00247741     History of Changes
Other Study ID Numbers: Articaine
First Posted: November 2, 2005    Key Record Dates
Last Update Posted: December 19, 2013
Last Verified: October 2005

Keywords provided by St. Antonius Hospital:
spinal anesthesia

Additional relevant MeSH terms:
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action