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
  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:


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
Arms Assigned Interventions
Active Comparator: lidocaine Drug: spinal administration of lidocaine
Experimental: articaine Drug: spinal administration of articaine

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: December 18, 2013
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
Lidocaine
Carticaine
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
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014