Spinal Anesthesia With Articaine and Bupivacaine for Outpatient Lower Limb Surgery - Full Text View

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:

Drug Information available for: Bupivacaine hydrochloride Articaine hydrochloride Articaine Bupivacaine Septocaine

U.S. FDA Resources

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

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:

Vree TB, Gielen MJ. Clinical pharmacology and the use of articaine for local and regional anaesthesia. Best Pract Res Clin Anaesthesiol. 2005 Jun;19(2):293-308. Review.

Alston RP. Spinal anaesthesia with 0.5% bupivacaine 3 ml: comparison of plain and hyperbaric solutions administered to seated patients. Br J Anaesth. 1988 Oct;61(4):385-9.

Axelsson KH, Widman GB, Sundberg AE, Hallgren S. A double-blind study of motor blockade in the lower limbs. Studies during spinal anaesthesia with hyperbaric and glucose-free 0.5% bupivacaine. Br J Anaesth. 1985 Oct;57(10):960-70.

Kaukinen S, Eerola R, Eerola M, Kaukinen L. A comparison of carticaine and lidocaine in spinal anaesthesia. Ann Clin Res. 1978 Aug;10(4):191-4.

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 May 19, 2013