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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

May 31, 2006
April 18, 2007
May 2006
Not Provided
recovery time from motor blockade
Same as current
Complete list of historical versions of study NCT00332735 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Spinal Anesthesia With Articaine and Bupivacaine for Outpatient Lower Limb Surgery
Spinal Anesthesia With 5% Articaine and 0.5% Bupivacaine for Outpatient Lower Limb Surgery. A Double-Blind Randomised Clinical Trial

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.

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
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Spinal Anesthesia
  • Drug: spinal administration of articaine
  • Drug: spinal administration of bupivacaine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
January 2007
Not Provided

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00332735
METC-nr 06-010
Not Provided
Not Provided
Reinier de Graaf Groep
Not Provided
Principal Investigator: Tessa Dijkstra, drs Reinier de Graaf Groep
Reinier de Graaf Groep
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP