Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2025-12-25 @ 7:40 PM
Study NCT ID:
NCT00332735
Status:
COMPLETED
Last Update Posted:
2007-04-19
First Post:
2006-05-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Spinal Anesthesia With Articaine and Bupivacaine for Outpatient Lower Limb Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-04', 'completionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-04-18', 'studyFirstSubmitDate': '2006-05-31', 'studyFirstSubmitQcDate': '2006-05-31', 'lastUpdatePostDateStruct': {'date': '2007-04-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-06-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'recovery time from motor blockade'}], 'secondaryOutcomes': [{'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'}]}, 'conditionsModule': {'keywords': ['spinal', 'anesthesia', 'articaine', 'bupivacaine', 'outpatient', 'surgery', 'limbs'], 'conditions': ['Spinal Anesthesia']}, 'referencesModule': {'references': [{'pmid': '15966499', 'type': 'BACKGROUND', '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.'}, {'pmid': '3190969', 'type': 'BACKGROUND', '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.'}, {'pmid': '4041323', 'type': 'BACKGROUND', '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.'}, {'pmid': '360957', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'The purpose of the trial is to compare two local anesthetics, articaine and bupivacaine for outpatient lower limb surgery.\n\nFaster 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.\n\nArticaine 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.\n\nSpinal anesthesia with articaine will be compared to spinal anesthesia with bupivacaine in a randomized double blind clinical trial.\n\nEndpoints are:\n\n* onset of sensory and motor block\n* maximum spread of sensory level\n* recovery from sensory and motor block\n* time to micturition\n* complications'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 70 years\n* Patients planned for an outpatient lower limb surgery\n* Procedure under spinal anesthesia\n* Informed consent\n\nExclusion Criteria:\n\n* Contra-indications spinal anesthesia\n* History of allergic reactions on amide-type local anesthetics\n* Length \\< 1.60 m or \\> 1.90 m\n* BMI \\< 18.5 kg/m2 or \\> 35 kg/m2\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT00332735', 'briefTitle': 'Spinal Anesthesia With Articaine and Bupivacaine for Outpatient Lower Limb Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Reinier de Graaf Groep'}, 'officialTitle': 'Spinal Anesthesia With 5% Articaine and 0.5% Bupivacaine for Outpatient Lower Limb Surgery. A Double-Blind Randomised Clinical Trial', 'orgStudyIdInfo': {'id': 'METC-nr 06-010'}}, 'armsInterventionsModule': {'interventions': [{'name': 'spinal administration of articaine', 'type': 'DRUG'}, {'name': 'spinal administration of bupivacaine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2275 CX', 'city': 'Voorburg', 'state': 'South Holland', 'country': 'Netherlands', 'facility': 'Reinier de Graaf Groep', 'geoPoint': {'lat': 52.07417, 'lon': 4.35972}}], 'overallOfficials': [{'name': 'Tessa Dijkstra, drs', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Reinier de Graaf Groep'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Reinier de Graaf Groep', 'class': 'OTHER'}}}}