- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00332735
Spinal Anesthesia With Articaine and Bupivacaine for Outpatient Lower Limb Surgery
Spinal Anesthesia With 5% Articaine and 0.5% Bupivacaine for Outpatient Lower Limb Surgery. A Double-Blind Randomised Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Zuid-Holland
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Voorburg, Zuid-Holland, Netherlands, 2275 CX
- Reinier de Graaf Groep
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
recovery time from motor blockade
|
Secondary Outcome Measures
Outcome Measure |
---|
complications
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tessa Dijkstra, drs, Reinier de Graaf Groep
Publications and helpful links
General 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. doi: 10.1016/j.bpa.2004.12.006.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- METC-nr 06-010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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