Spinal Anesthesia With Articaine and Bupivacaine for Outpatient Lower Limb Surgery

This study has been completed.
Sponsor:
Information provided by:
Reinier de Graaf Groep
ClinicalTrials.gov Identifier:
NCT00332735
First received: May 31, 2006
Last updated: April 18, 2007
Last verified: April 2007
  Purpose

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.


Condition Intervention Phase
Spinal Anesthesia
Drug: spinal administration of articaine
Drug: spinal administration of bupivacaine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Spinal Anesthesia With 5% Articaine and 0.5% Bupivacaine for Outpatient Lower Limb Surgery. A Double-Blind Randomised Clinical Trial

Resource links provided by NLM:


Further study details as provided by Reinier de Graaf Groep:

Primary Outcome Measures:
  • recovery time from motor blockade

Secondary Outcome Measures:
  • 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
  • complications

Estimated Enrollment: 80
Study Start Date: May 2006
Study Completion Date: January 2007
Detailed Description:

The purpose of the trial is to compare two local anesthetics, articaine and bupivacaine for outpatient lower limb surgery.

Faster onset and shorter elimination time favours a short-acting local anaesthetic for spinal anesthesia for out-patient lower limb surgery, e.g. knee arthroscopy, foot and varices surgery. Patients will recover faster and less complications will be expected.

Articaine is said to act faster and shorter than a low dose of bupivacaine. There are not enough data available to establish that articaine is as safe as and more effective by outpatient lower limb surgery than bupivacaine.

Spinal anesthesia with articaine will be compared to spinal anesthesia with bupivacaine in a randomized double blind clinical trial.

Endpoints are:

  • onset of sensory and motor block
  • maximum spread of sensory level
  • recovery from sensory and motor block
  • time to micturition
  • complications
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00332735

Locations
Netherlands
Reinier de Graaf Groep
Voorburg, Zuid-Holland, Netherlands, 2275 CX
Sponsors and Collaborators
Reinier de Graaf Groep
Investigators
Principal Investigator: Tessa Dijkstra, drs Reinier de Graaf Groep
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00332735     History of Changes
Other Study ID Numbers: METC-nr 06-010
Study First Received: May 31, 2006
Last Updated: April 18, 2007
Health Authority: The Netherlands: Medical Ethics Committee South-West Holland
The Netherlands: central committee of human related investigation

Keywords provided by Reinier de Graaf Groep:
spinal
anesthesia
articaine
bupivacaine
outpatient
surgery
limbs

Additional relevant MeSH terms:
Anesthetics
Bupivacaine
Carticaine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on August 28, 2014