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Spinal Anesthesia With Articaine and Lidocaine for Outpatient Surgery.

NCT ID: NCT00247741

Last Updated: 2013-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2006-05-31

Brief Summary

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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

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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

Conditions

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Spinal Anesthesia

Keywords

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spinal anesthesia lidocaine articaine intrathecal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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lidocaine

Group Type ACTIVE_COMPARATOR

spinal administration of lidocaine

Intervention Type DRUG

articaine

Group Type EXPERIMENTAL

spinal administration of articaine

Intervention Type DRUG

Interventions

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spinal administration of articaine

Intervention Type DRUG

spinal administration of lidocaine

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Antonius Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Leon Timmerman, MD

Role: PRINCIPAL_INVESTIGATOR

St Antonius Hospital, dept. of anesthesiology

Emile MJ Andriessen, MD

Role: STUDY_CHAIR

St Antonius Hospital, dept of anesthesiology

Locations

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St Antonius Hospital

Nieuwegein, Utrecht, Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type BACKGROUND
PMID: 15966499 (View on PubMed)

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.

Reference Type RESULT
PMID: 360957 (View on PubMed)

Other Identifiers

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Articaine

Identifier Type: -

Identifier Source: org_study_id