Spinal Anesthesia With Articaine and Lidocaine for Outpatient Surgery.

Phase 3

Completed

• Conditions: Spinal Anesthesia
• Interventions: Drug: spinal administration of articaine; Drug: spinal administration of lidocaine

• Registration Number: NCT00247741
• Lead Sponsor: St. Antonius Hospital

Brief 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.

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 Timeline

• Status Verified: 2005-10
• Study Start: 2005-11
• Study First Submitted: 2005-11-01
• Study First Submitted QC: 2005-11-01
• Study First Posted: 2005-11-02
• Study Completion: 2006-05
• Last Update Submitted: 2013-12-18
• Last Update Posted: 2013-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
articaine	spinal administration of articaine	-
lidocaine	spinal administration of lidocaine	-

Primary Outcome Measures

Name	Time	Method
Onset time (sec) of sensory and motor blockade (after administration of drug)
Spread of sensory blockade (30 min after administration of drug, dermatomal level)
Recovery time (min) from sensory and motor blockade

Secondary Outcome Measures

Name	Time	Method
Hemodynamic stability (lowest systolic blood pressure, vasopressor therapy)
Complications
Patient satisfaction

Trial Locations

Locations (1)

St Antonius Hospital; 🇳🇱 Nieuwegein, Utrecht, Netherlands