Clinical trial NCT00332735: Spinal Anesthesia With Articaine and Bupivacaine for Outpatient Lower Limb Surgery
Official title: Spinal Anesthesia With 5% Articaine and 0.5% Bupivacaine for Outpatient Lower Limb Surgery. A Double-Blind Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Spinal Anesthesia
Keywords: spinal
anesthesia
articaine
bupivacaine
outpatient
surgery
limbs
Lead sponsor: Reinier de Graaf Groep
Sponsor class: OTHER
First posted: 2006-06-02
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: recovery time from motor blockade
Secondary outcomes:
measure: onset of sensory and motor blockade
measure: maximum spread of sensory blockade (30 min after spinal injection of anesthetic)
measure: spread of sensory blockade after 1,5 hour
measure: recovery time from sensory blockade
measure: time to micturation
measure: complications
Other outcomes:
Locations:
city: Voorburg
country: Netherlands
facility: Reinier de Graaf Groep
state: Zuid-Holland
Study officials:
affiliation: Reinier de Graaf Groep
name: Tessa Dijkstra, drs
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1016/j.bpa.2004.12.006.
citation: 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. doi: 10.1093/bja/61.4.385.
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. doi: 10.1093/bja/57.10.960.
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.