NCT00247741

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2005

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2005

Completed
Same day until next milestone

Study Start

First participant enrolled

November 1, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2005

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

December 19, 2013

Status Verified

October 1, 2005

First QC Date

November 1, 2005

Last Update Submit

December 18, 2013

Conditions

Spinal Anesthesia

Keywords

spinal anesthesialidocainearticaineintrathecal

Outcome Measures

Primary Outcomes (3)

  • 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 (3)

  • Hemodynamic stability (lowest systolic blood pressure, vasopressor therapy)

  • Complications

  • Patient satisfaction

Study Arms (2)

lidocaine

ACTIVE COMPARATOR
Drug: spinal administration of lidocaine

articaine

EXPERIMENTAL
Drug: spinal administration of articaine

Interventions

spinal administration of articaineDRUG
articaine
spinal administration of lidocaineDRUG
lidocaine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Contra-indications spinal anesthesia
  • History of allergic reactions on amide-type local anesthetics
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Antonius Hospital

Nieuwegein, Utrecht, 3435 CM, Netherlands

Location

Related Publications (2)

  • 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.

    PMID: 15966499BACKGROUND

  • 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.

    PMID: 360957RESULT

Study Officials

  • Leon Timmerman, MD

    St Antonius Hospital, dept. of anesthesiology

    PRINCIPAL INVESTIGATOR

  • Emile MJ Andriessen, MD

    St Antonius Hospital, dept of anesthesiology

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 2005

First Posted

November 2, 2005

Study Start

November 1, 2005

Study Completion

May 1, 2006

Last Updated

December 19, 2013

Record last verified: 2005-10

Locations

NL(1)