Spinal Anesthesia With Articaine and Lidocaine for Outpatient Surgery.

Spinal Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00247741
• Other study ID #: Articaine
• Status: Completed
• Phase: Phase 3
• First received: November 1, 2005
• Last updated: December 18, 2013
• Start date: November 2005
• Est. completion date: May 2006

Study information

• Verified date: October 2005
• Source: St. Antonius Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: European Agency for the Evaluation of Medicinal Prodocts (EMEA)
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Anesthesia

Intervention

Drug:
• spinal administration of articaine

• spinal administration of lidocaine

Locations

Country	Name	City	State
Netherlands	St Antonius Hospital	Nieuwegein	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
St. Antonius Hospital

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

Kaukinen S, Eerola R, Eerola M, Kaukinen L. A comparison of carticaine and lidocaine in spinal anaesthesia. Ann Clin Res. 1978 Aug;10(4):191-4. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Onset time (sec) of sensory and motor blockade (after administration of drug)
Primary	Recovery time (min) from sensory and motor blockade
Primary	Spread of sensory blockade (30 min after administration of drug, dermatomal level)
Secondary	Hemodynamic stability (lowest systolic blood pressure, vasopressor therapy)
Secondary	Complications
Secondary	Patient satisfaction