Spinal Anesthesia With Articaine and Lidocaine for Outpatient Surgery.

This study has been completed.
Sponsor:
Information provided by:
St. Antonius Hospital
ClinicalTrials.gov Identifier:
NCT00247741
First received: November 1, 2005
Last updated: December 18, 2013
Last verified: October 2005

November 1, 2005
December 18, 2013
November 2005
Not Provided
  • 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)
Same as current
Complete list of historical versions of study NCT00247741 on ClinicalTrials.gov Archive Site
  • Hemodynamic stability (lowest systolic blood pressure, vasopressor therapy)
  • Complications
  • Patient satisfaction
Same as current
Not Provided
Not Provided
 
Spinal Anesthesia With Articaine and Lidocaine for Outpatient Surgery.
Spinal Anesthesia With Articaine and Lidocaine for Outpatient Surgery: A Double Blind Randomized Clinical Trial.

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.

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
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Spinal Anesthesia
  • Drug: spinal administration of articaine
  • Drug: spinal administration of lidocaine
  • Active Comparator: lidocaine
    Intervention: Drug: spinal administration of lidocaine
  • Experimental: articaine
    Intervention: Drug: spinal administration of articaine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
May 2006
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00247741
Articaine
No
Not Provided
St. Antonius Hospital
Not Provided
Principal Investigator: Leon Timmerman, MD St Antonius Hospital, dept. of anesthesiology
Study Chair: Emile MJ Andriessen, MD St Antonius Hospital, dept of anesthesiology
St. Antonius Hospital
October 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP