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Spinal Anesthesia With Articaine and Bupivacaine for Outpatient Lower Limb Surgery

R

Reinier de Graaf Groep

Status and phase

Completed
Phase 3

Conditions

Spinal Anesthesia

Treatments

Drug: spinal administration of bupivacaine
Drug: spinal administration of articaine

Study type

Interventional

Funder types

Other

Identifiers

NCT00332735
METC-nr 06-010

Details and patient eligibility

About

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.

Full 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

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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