Spinal Anesthesia With Articaine and Bupivacaine for Outpatient Lower Limb Surgery

Spinal Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00332735
• Other study ID #: METC-nr 06-010
• Status: Completed
• Phase: Phase 3
• First received: May 31, 2006
• Last updated: April 18, 2007
• Start date: May 2006
• Est. completion date: January 2007

Study information

• Verified date: April 2007
• Source: Reinier de Graaf Groep
• Contact: n/a
• Is FDA regulated: No
• Health authority: The Netherlands: Medical Ethics Committee South-West HollandThe Netherlands: central committee of human related investigation
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Anesthesia

Intervention

Drug:
• spinal administration of articaine

• spinal administration of bupivacaine

Locations

Country	Name	City	State
Netherlands	Reinier de Graaf Groep	Voorburg	Zuid-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Reinier de Graaf Groep

Country where clinical trial is conducted

Netherlands, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recovery time from motor blockade
Secondary	onset of sensory and motor blockade
Secondary	maximum spread of sensory blockade (30 min after spinal injection of anesthetic)
Secondary	spread of sensory blockade after 1,5 hour
Secondary	recovery time from sensory blockade
Secondary	time to micturation
Secondary	complications