Spinal Anesthesia With Articaine and Lidocaine for Outpatient Surgery.

December 18, 2013 updated by: St. Antonius Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment

80

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Utrecht
      • Nieuwegein, Utrecht, Netherlands, 3435 CM
        • St Antonius hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: lidocaine
Drug: spinal administration of lidocaine
Experimental: articaine
Drug: spinal administration of articaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
Complications
Patient satisfaction
Hemodynamic stability (lowest systolic blood pressure, vasopressor therapy)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Study Completion

May 1, 2006

Study Registration Dates

First Submitted

November 1, 2005

First Submitted That Met QC Criteria

November 1, 2005

First Posted (Estimate)

November 2, 2005

Study Record Updates

Last Update Posted (Estimate)

December 19, 2013

Last Update Submitted That Met QC Criteria

December 18, 2013

Last Verified

October 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • articaine

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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