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Spinal Anesthesia With Articaine and Lidocaine for Outpatient Surgery.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2005 by St. Antonius Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
St. Antonius Hospital
ClinicalTrials.gov Identifier:
NCT00247741
First received: November 1, 2005
Last updated: May 15, 2006
Last verified: October 2005
History of Changes
  Purpose

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 Intervention Phase
Spinal Anesthesia
 Drug: spinal administration of articaine
Drug: spinal administration of lidocaine
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Spinal Anesthesia With Articaine and Lidocaine for Outpatient Surgery: A Double Blind Randomized Clinical Trial.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by St. Antonius Hospital:

Primary Outcome Measures:
  • 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 Measures:
  • Hemodynamic stability (lowest systolic blood pressure, vasopressor therapy)
  • Complications
  • Patient satisfaction

Estimated Enrollment: 80
Study Start Date: November 2005
Estimated Study Completion Date: May 2006
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00247741

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

Publications:

ClinicalTrials.gov Identifier: NCT00247741     History of Changes
Other Study ID Numbers: Articaine
Study First Received: November 1, 2005
Last Updated: May 15, 2006
Health Authority: Netherlands: European Agency for the Evaluation of Medicinal Prodocts (EMEA)

Keywords provided by St. Antonius Hospital:
spinal anesthesia
lidocaine
articaine
intrathecal

Additional relevant MeSH terms:
Anesthetics
Carticaine
Lidocaine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
 Therapeutic Uses
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 22, 2013