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Completed

NCT Number: NCT00332735

Spinal Anesthesia With Articaine and Bupivacaine for Outpatient Lower Limb Surgery

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.

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Key information

Conditions

Spinal Anesthesia

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Reinier de Graaf Groep

Voorburg, South Holland, 2275 CX, Netherlands

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

spinal administration of articaine

Drug

spinal administration of bupivacaine

Drug

Primary outcomes

  1. recovery time from motor blockade

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Reinier de Graaf Groep

Other

Registry information

Official study title

Spinal Anesthesia With 5% Articaine and 0.5% Bupivacaine for Outpatient Lower Limb Surgery. A Double-Blind Randomised Clinical Trial

Important dates

Study start
2006
Study completion
2007
First posted
Jun 2, 2006
Registry last updated
Apr 19, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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