Clinical trial NCT00247741: Spinal Anesthesia With Articaine and Lidocaine for Outpatient Surgery.
Official title: Spinal Anesthesia With Articaine and Lidocaine for Outpatient Surgery: A Double Blind Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Spinal Anesthesia
Keywords: spinal anesthesia
lidocaine
articaine
intrathecal
Lead sponsor: St. Antonius Hospital
Sponsor class: OTHER
First posted: 2005-11-02
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: Onset time (sec) of sensory and motor blockade (after administration of drug)
measure: Recovery time (min) from sensory and motor blockade
measure: Spread of sensory blockade (30 min after administration of drug, dermatomal level)
Secondary outcomes:
measure: Hemodynamic stability (lowest systolic blood pressure, vasopressor therapy)
measure: Complications
measure: Patient satisfaction
Other outcomes:
Locations:
city: Nieuwegein
country: Netherlands
facility: St Antonius Hospital
state: Utrecht
Study officials:
affiliation: St Antonius Hospital, dept. of anesthesiology
name: Leon Timmerman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St Antonius Hospital, dept of anesthesiology
name: Emile MJ Andriessen, MD
role: STUDY_CHAIR
References:
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. doi: 10.1016/j.bpa.2004.12.006.
citation: 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.