Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2026-02-21 @ 1:35 PM
Study NCT ID:
NCT02033356
Status:
COMPLETED
Last Update Posted:
2014-04-04
First Post:
2014-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ED95 of Lidocaine 1.0% for Filling the Adductor Canal
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-03', 'studyFirstSubmitDate': '2014-01-09', 'studyFirstSubmitQcDate': '2014-01-09', 'lastUpdatePostDateStruct': {'date': '2014-04-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To estimate the ED 95 for the volume needed to fill the adductor canal distally.', 'timeFrame': 'MRI performed 15 minutes post block', 'description': 'This will be evaluated as a binary outcome using MRI; where the adductor canal is considered to be filled if the lidocaine injectate can be identified inside the canal in the first slice distally to the insertion of the adductor longus muscle on femur.'}], 'secondaryOutcomes': [{'measure': 'To investigate the effect of volume on proximal spread to the femoral triangle', 'timeFrame': 'MRI performed 15 minutes post block', 'description': 'Evaluated as a binary outcome using MRI'}, {'measure': 'Quadriceps muscle strength', 'timeFrame': '1 hour post block', 'description': 'To investigate the effect of volume on quadriceps muscle strength, assessed as maximum voluntary isometric contraction (MVIC) and evaluated as a binary outcome (reduction by more or less than 25%).'}, {'measure': 'Pin prick test', 'timeFrame': '1 hour post block', 'description': 'To investigate the effect of volume on sensory block assessed by pin-prick in the saphenous innervation area and in the popliteal fossa.'}, {'measure': 'Temperature discrimination test', 'timeFrame': '1 hour post block', 'description': 'To investigate the effect of volume on sensory block assessed by cold sensation using alchohol swabs, in the saphenous innervation area and in the popliteal fossa.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['adductor canal block', 'volunteers', 'US-guided peripheral nerve block', 'lower limb', 'MRI'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '26582853', 'type': 'DERIVED', 'citation': 'Jaeger P, Jenstrup MT, Lund J, Siersma V, Brondum V, Hilsted KL, Dahl JB. Optimal volume of local anaesthetic for adductor canal block: using the continual reassessment method to estimate ED95. Br J Anaesth. 2015 Dec;115(6):920-6. doi: 10.1093/bja/aev362.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this prospective dose finding study is to estimate the minimal effective volume (ED95) for lidocaine 1.0% for filling the adductor canal when placing an adductor canal block. We will apply the Continual Reassessment Method (CRM) for estimating the ED95 and use an MRI scan to evaluate the main objective and ensure spread to the distal part of the adductor canal.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18-30 years\n* Men\n* American Society of Anesthesiologists' class 1\n* Body Mass Index 18-25\n\nExclusion Criteria:\n\n* Allergy to study medication\n* Earlier trauma or surgery to the lower limb\n* Diabetes Mellitus - Contraindications to MRI"}, 'identificationModule': {'nctId': 'NCT02033356', 'briefTitle': 'ED95 of Lidocaine 1.0% for Filling the Adductor Canal', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'An Estimate of the ED95 of Lidocaine 1.0% for Filling the Adductor Canal When Placing an Adductor Canal Block in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'SM3-PJ-13'}, 'secondaryIdInfos': [{'id': '2013-004462-33', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ACB with 30 ml lidocaine 1%', 'description': 'Procedure/Surgery: Adductor canal block with lidocaine 1% The Continual Reassessment Method is used to calculate the dose level consecutively for every new cohort (2 subjects) in the study.\n\nPossible dose levels are: 5, 10, 15, 20, 25 and 30 ml.', 'interventionNames': ['Procedure: Adductor canal block with lidocaine 1%', 'Drug: Lidocaine']}, {'type': 'EXPERIMENTAL', 'label': 'ACB with 25 ml lidocaine 1%', 'description': 'Procedure/Surgery: Adductor canal block with lidocaine 1% The Continual Reassessment Method is used to calculate the dose level consecutively for every new cohort (2 subjects) in the study.\n\nPossible dose levels are: 5, 10, 15, 20, 25 and 30 ml.', 'interventionNames': ['Procedure: Adductor canal block with lidocaine 1%', 'Drug: Lidocaine']}, {'type': 'EXPERIMENTAL', 'label': 'ACB with 20 ml lidocaine 1%', 'description': 'Procedure/Surgery: Adductor canal block with lidocaine 1% The Continual Reassessment Method is used to calculate the dose level consecutively for every new cohort (2 subjects) in the study.\n\nPossible dose levels are: 5, 10, 15, 20, 25 and 30 ml.', 'interventionNames': ['Procedure: Adductor canal block with lidocaine 1%', 'Drug: Lidocaine']}, {'type': 'EXPERIMENTAL', 'label': 'ACB with 15 ml lidocaine 1%', 'description': 'Procedure/Surgery: Adductor canal block with lidocaine 1% The Continual Reassessment Method is used to calculate the dose level consecutively for every new cohort (2 subjects) in the study.\n\nPossible dose levels are: 5, 10, 15, 20, 25 and 30 ml.', 'interventionNames': ['Procedure: Adductor canal block with lidocaine 1%', 'Drug: Lidocaine']}, {'type': 'EXPERIMENTAL', 'label': 'ACB with 10 ml lidocaine 1%', 'description': 'Procedure/Surgery: Adductor canal block with lidocaine 1% The Continual Reassessment Method is used to calculate the dose level consecutively for every new cohort (2 subjects) in the study.\n\nPossible dose levels are: 5, 10, 15, 20, 25 and 30 ml.', 'interventionNames': ['Procedure: Adductor canal block with lidocaine 1%', 'Drug: Lidocaine']}, {'type': 'EXPERIMENTAL', 'label': 'ACB with 5 ml lidocaine 1%', 'description': 'Procedure/Surgery: Adductor canal block with lidocaine 1% The Continual Reassessment Method is used to calculate the dose level consecutively for every new cohort (2 subjects) in the study.\n\nPossible dose levels are: 5, 10, 15, 20, 25 and 30 ml.', 'interventionNames': ['Procedure: Adductor canal block with lidocaine 1%', 'Drug: Lidocaine']}], 'interventions': [{'name': 'Adductor canal block with lidocaine 1%', 'type': 'PROCEDURE', 'description': 'US-guided adductor canal block', 'armGroupLabels': ['ACB with 10 ml lidocaine 1%', 'ACB with 15 ml lidocaine 1%', 'ACB with 20 ml lidocaine 1%', 'ACB with 25 ml lidocaine 1%', 'ACB with 30 ml lidocaine 1%', 'ACB with 5 ml lidocaine 1%']}, {'name': 'Lidocaine', 'type': 'DRUG', 'armGroupLabels': ['ACB with 10 ml lidocaine 1%', 'ACB with 15 ml lidocaine 1%', 'ACB with 20 ml lidocaine 1%', 'ACB with 25 ml lidocaine 1%', 'ACB with 30 ml lidocaine 1%', 'ACB with 5 ml lidocaine 1%']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2860', 'city': 'Søborg', 'country': 'Denmark', 'facility': 'Aleris-Hamlet Hospitals Copenhagen', 'geoPoint': {'lat': 56.08481, 'lon': 12.31803}}], 'overallOfficials': [{'name': 'Pia Jaeger, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anaesthesia, HOC, Rigshospitalet, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Pia Jaeger', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}