NCT00332735

Brief Summary

The purpose of the trial is to compare two local anesthetics, articaine and bupivacaine for outpatient lower limb surgery. Onset and recovery times of sensory and motor blockade will be compared.

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 May 2006

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

Study Start

First participant enrolled

May 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 31, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 2, 2006

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

April 19, 2007

Status Verified

April 1, 2007

First QC Date

May 31, 2006

Last Update Submit

April 18, 2007

Conditions

Spinal Anesthesia

Keywords

spinalanesthesiaarticainebupivacaineoutpatientsurgerylimbs

Outcome Measures

Primary Outcomes (1)

  • recovery time from motor blockade

Secondary Outcomes (6)

  • onset of sensory and motor blockade

  • maximum spread of sensory blockade (30 min after spinal injection of anesthetic)

  • spread of sensory blockade after 1,5 hour

  • recovery time from sensory blockade

  • time to micturation

  • +1 more secondary outcomes

Interventions

spinal administration of articaineDRUG
spinal administration of bupivacaineDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 70 years
  • Patients planned for an outpatient lower limb surgery
  • Procedure under spinal anesthesia
  • Informed consent

You may not qualify if:

  • Contra-indications spinal anesthesia
  • History of allergic reactions on amide-type local anesthetics
  • Length \< 1.60 m or \> 1.90 m
  • BMI \< 18.5 kg/m2 or \> 35 kg/m2
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reinier de Graaf Groep

Voorburg, South Holland, 2275 CX, Netherlands

Location

Related Publications (4)

  • 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

  • Alston RP. Spinal anaesthesia with 0.5% bupivacaine 3 ml: comparison of plain and hyperbaric solutions administered to seated patients. Br J Anaesth. 1988 Oct;61(4):385-9. doi: 10.1093/bja/61.4.385.

    PMID: 3190969BACKGROUND

  • Axelsson KH, Widman GB, Sundberg AE, Hallgren S. A double-blind study of motor blockade in the lower limbs. Studies during spinal anaesthesia with hyperbaric and glucose-free 0.5% bupivacaine. Br J Anaesth. 1985 Oct;57(10):960-70. doi: 10.1093/bja/57.10.960.

    PMID: 4041323BACKGROUND

  • 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: 360957BACKGROUND

Study Officials

  • Tessa Dijkstra, drs

    Reinier de Graaf Groep

    PRINCIPAL INVESTIGATOR

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

May 31, 2006

First Posted

June 2, 2006

Study Start

May 1, 2006

Study Completion

January 1, 2007

Last Updated

April 19, 2007

Record last verified: 2007-04

Locations

NL(1)