Spinal Anesthesia With Articaine and Bupivacaine for Outpatient Lower Limb Surgery

• Sponsor: Reinier de Graaf Groep (Other)
• Overall Status: Completed
• CT.gov ID: NCT00332735
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Duration (Months): 8
• Patients Per Site Per Month: 9.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Anesthesia	Drug: spinal administration of articaine; Drug: spinal administration of bupivacaine	Phase 3

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

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• 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
• Study Start Date: May 1, 2006
• Actual Study Completion Date: Jan 1, 2007

Outcome Measures

Primary Outcome Measures

1. recovery time from motor blockade []

Secondary Outcome Measures

1. onset of sensory and motor blockade []

2. maximum spread of sensory blockade (30 min after spinal injection of anesthetic) []

3. spread of sensory blockade after 1,5 hour []

4. recovery time from sensory blockade []

5. time to micturation []

6. complications []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• ClinicalTrials.gov Identifier: NCT00332735
• Other Study ID Numbers: METC-nr 06-010
• First Posted: Jun 2, 2006
• Last Update Posted: Apr 19, 2007
• Last Verified: Apr 1, 2007

• Keywords provided by , ,: spinal; anesthesia; articaine; bupivacaine; outpatient; surgery; limbs
• Additional relevant MeSH terms: Bupivacaine; Carticaine

Study Results

No Results Posted as of Apr 19, 2007