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Spinal Anesthesia With Articaine and Bupivacaine for Outpatient Lower Limb Surgery

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ClinicalTrials.gov Identifier: NCT00332735
Recruitment Status : Completed
First Posted : June 2, 2006
Last Update Posted : April 19, 2007
Sponsor:
Information provided by:
Reinier de Graaf Groep

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.

Condition or disease Intervention/treatment Phase
Spinal Anesthesia Drug: spinal administration of articaine Drug: spinal administration of bupivacaine Phase 3

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

Study Type : Interventional  (Clinical Trial)
Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : May 2006
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources




Primary Outcome Measures :
  1. recovery time from motor blockade

Secondary Outcome Measures :
  1. onset of sensory and motor blockade
  2. maximum spread of sensory blockade (30 min after spinal injection of anesthetic)
  3. spread of sensory blockade after 1,5 hour
  4. recovery time from sensory blockade
  5. time to micturation
  6. complications


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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