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Completed

NCT Number: NCT00247741

Spinal Anesthesia With Articaine and Lidocaine for Outpatient Surgery.

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.

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Key information

Conditions

Spinal Anesthesia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

St Antonius Hospital

Nieuwegein, Utrecht, 3435 CM, Netherlands

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

spinal administration of articaine

Drug

spinal administration of lidocaine

Drug

Primary outcomes

  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 outcomes

  1. Hemodynamic stability (lowest systolic blood pressure, vasopressor therapy)

  2. Complications

  3. Patient satisfaction

Sponsors and collaborators

Lead sponsor

St. Antonius Hospital

Other

Registry information

Official study title

Spinal Anesthesia With Articaine and Lidocaine for Outpatient Surgery: A Double Blind Randomized Clinical Trial.

Important dates

Study start
2005
Study completion
2006
First posted
Nov 2, 2005
Registry last updated
Dec 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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