Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2026-02-27 @ 2:20 PM
Study NCT ID:
NCT03038958
Status:
COMPLETED
Last Update Posted:
2019-11-18
First Post:
2017-01-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Hyperbaric Prilocaine With Chloroprocaine for Intrathecal Anaesthesia in Day Case Knee Arthroscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-15', 'studyFirstSubmitDate': '2017-01-26', 'studyFirstSubmitQcDate': '2017-01-30', 'lastUpdatePostDateStruct': {'date': '2019-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of sensory block', 'timeFrame': 'Until complete release of sensory block', 'description': 'Total duration of sensory block is the interval time between the end of intrathecal injection and the complete recovery of sensory block'}], 'secondaryOutcomes': [{'measure': 'Onset time of sensory block', 'timeFrame': 'up to 30 minutes', 'description': 'The levels of sensory block will be determined at 5, 10, 20 and 30 minutes after intrathecal injection. The levels of sensory block will be assessed as loss of sensation to pin-prick and cold.'}, {'measure': 'Onset time of motor block', 'timeFrame': 'up to 30 minutes', 'description': 'The levels of motor block will be determined at 5, 10, 20 and 30 minutes after intrathecal injection. The levels of motor block will be assessed by using the Bromage Scale (0=no motor block; 1=hip blocked; 2=hip and knee blocked; 3=hip, knee, and ankle blocked).'}, {'measure': 'Duration of motor block', 'timeFrame': 'Until complete regression of motor block', 'description': 'Total duration of motor block is the interval time between the end of intrathecal injection and the complete recovery of motor block'}, {'measure': 'Pain assessed by Visual Analog Scale', 'timeFrame': 'up to 24 hours', 'description': 'Pain levels will be determined at the inflation of tourniquet, at the incision and every 10 minutes in the PACU (Post Anesthesia Care Unit). Visual Analog pain score (scale = 0 no pain; 10 = worst pain imaginable).'}, {'measure': 'Side-effects (hypotension, bradycardia, urinary retention)', 'timeFrame': 'up to 24 hours', 'description': 'Assessed during and after intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Local Anaesthetic', 'spinal anesthesia', 'Knee arthroscopy'], 'conditions': ['Knee Arthroscopy', 'Spinal Anesthesia']}, 'descriptionModule': {'briefSummary': 'This study compares intrathecal 1% plain chloroprocaine with intrathecal 2% hyperbaric prilocaine for patients undergoing ambulatory knee arthroscopy in terms of efficacy and side effects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiology physical status (ASA) ≤ III\n* Age 18-80 year\n* Height between 160 and 185 cm\n* Signed informed consent obtained prior to any study specific assessments and procedures\n\nExclusion Criteria:\n\n* Cardiac pathology (such as Heart failure, Aortic stenosis)\n* Coagulation disorders (INR\\>1.3, platelet \\< 80 000/mm3)\n* Known allergy to local anaesthetics\n* Disagreement of the patient'}, 'identificationModule': {'nctId': 'NCT03038958', 'briefTitle': 'Comparison of Hyperbaric Prilocaine With Chloroprocaine for Intrathecal Anaesthesia in Day Case Knee Arthroscopy', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Saint Pierre'}, 'officialTitle': 'Comparison of Hyperbaric Prilocaine With Chloroprocaine for Intrathecal Anaesthesia in Day Case Knee Arthroscopy', 'orgStudyIdInfo': {'id': 'AK160324627AD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Isobaric 2-chloroprocaine', 'description': 'The 50 mg dose of isobaric 2-chloroprocaine will be administered to patients undergoing ambulatory knee arthroscopy', 'interventionNames': ['Drug: Isobaric 2-chloroprocaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hyperbaric prilocaine 2%', 'description': 'The dose of 50 mg of Hyperbaric prilocaine 2% will be administered to patients undergoing ambulatory knee arthroscopy', 'interventionNames': ['Drug: Hyperbaric prilocaine']}], 'interventions': [{'name': 'Isobaric 2-chloroprocaine', 'type': 'DRUG', 'otherNames': ['Ampres'], 'description': 'intrathecal injection of 50 mg isobaric 2-Chloroprocaine', 'armGroupLabels': ['Isobaric 2-chloroprocaine']}, {'name': 'Hyperbaric prilocaine', 'type': 'DRUG', 'otherNames': ['Tachipri'], 'description': 'intrathecal injection of 50 mg hyperbaric prilocaine 2%', 'armGroupLabels': ['Hyperbaric prilocaine 2%']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1420', 'city': "Braine-l'Alleud", 'country': 'Belgium', 'facility': "Braine-l'Alleud Hospital", 'geoPoint': {'lat': 50.68363, 'lon': 4.36784}}, {'zip': '1000', 'city': 'Brussels Capital Region', 'country': 'Belgium', 'facility': 'CHU Saint-Pierre'}], 'overallOfficials': [{'name': 'Emmanuel Guntz, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': "Université Libre de Bruxelles (ULB), Braine-l'Alleud Hospital"}, {'name': 'Panayota Kapessidou, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Saint Pierre', 'class': 'OTHER'}, 'collaborators': [{'name': "Hôpital de Braine-l'Alleud", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}