Spinal Anesthesia With Articaine and Bupivacaine for Outpatient Lower Limb Surgery

Condition(s) targeted: Spinal Anesthesia

Intervention: spinal administration of articaine (Drug); spinal administration of bupivacaine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Reinier de Graaf Groep

Official(s) and/or principal investigator(s):
Tessa Dijkstra, drs, Principal Investigator, Affiliation: Reinier de Graaf Groep

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.

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

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: recovery time from motor blockade

Secondary outcome:

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

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

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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

Reinier de Graaf Groep, Voorburg, Zuid-Holland 2275 CX, Netherlands

Related 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.

Starting date: May 2006
Ending date: January 2007
Last updated: April 18, 2007