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Spinal Anesthesia With Articaine and Lidocaine for Outpatient Surgery.

Information source: St. Antonius Hospital
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Spinal Anesthesia

Intervention: spinal administration of articaine (Drug); spinal administration of lidocaine (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: St. Antonius Hospital

Official(s) and/or principal investigator(s):
Leon Timmerman, MD, Principal Investigator, Affiliation: St Antonius Hospital, dept. of anesthesiology
Emile MJ Andriessen, MD, Study Chair, Affiliation: St Antonius Hospital, dept of anesthesiology

Summary

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.

Clinical Details

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

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

Primary outcome:

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:

Hemodynamic stability (lowest systolic blood pressure, vasopressor therapy)

Complications

Patient satisfaction

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

St Antonius Hospital, Nieuwegein, Utrecht 3435 CM, Netherlands
Additional Information

Related publications:

Vree TB, Gielen MJ. Clinical pharmacology and the use of articaine for local and regional anaesthesia. Best Pract Res Clin Anaesthesiol. 2005 Jun;19(2):293-308. Review.

Starting date: November 2005
Ending date: May 2006
Last updated: May 15, 2006

Page last updated: June 20, 2008

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