Spinal Anesthesia With Articaine and Lidocaine for Outpat... | NCT00247741

Studies
Spinal Anesthesia With Articaine and Lidocaine for Outpatient Surgery.

NCT00247741

Sponsor

St. Antonius Hospital

Status

Completed

Last Update Posted

Dec 19, 2013Estimated

Enrollment

Phase

Phase 3

Conditions

Spinal Anesthesia

Interventions

spinal administration of articaine
spinal administration of lidocaine

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2005

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2005

Primary Completion Date

Not provided

Completion Date

May 2006

First Submitted Date

Nov 1, 2005

First Submission Date that Met QC Criteria

Nov 1, 2005

First Posted Date

Nov 2, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 18, 2013

Last Update Posted Date

Dec 19, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
lidocaine	Active Comparator		Drug: spinal administration of lidocaine
articaine	Experimental		Drug: spinal administration of articaine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
spinal administration of articaine	Drug		articaine
spinal administration of lidocaine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
Hemodynamic stability (lowest systolic blood pressure, vasopressor therapy)
Complications
Patient satisfaction

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Leon Timmerman, MD	St Antonius Hospital, dept. of anesthesiology	Principal Investigator
Emile MJ Andriessen, MD	St Antonius Hospital, dept of anesthesiology	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St Antonius Hospital		Nieuwegein	Utrecht	3435 CM	Netherlands

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15966499	Background	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.
360957	Result	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.