Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2026-03-31 @ 6:17 PM
Study NCT ID:
NCT02351804
Status:
COMPLETED
Last Update Posted:
2015-09-01
First Post:
2015-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Perineural Dexamethasone Prolong Duration of a Nerve Block?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077212', 'term': 'Ropivacaine'}, {'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-31', 'studyFirstSubmitDate': '2015-01-27', 'studyFirstSubmitQcDate': '2015-01-29', 'lastUpdatePostDateStruct': {'date': '2015-09-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in duration of sensory block between dexamethasone and placebo assessed as cold sensation with an alcohol swab', 'timeFrame': '0-36 hours', 'description': 'Duration is defined as time from block performance until recovery of cold sensation to an alcohol swab, assessed every hour post-block (and every half hour when pain scores during the tonic heat stimulation test is above 0, except at 2 and 3 hours post block where there will be a break and no assessments will be performed.'}], 'secondaryOutcomes': [{'measure': 'Difference between dexamethasone and placebo in the duration of a sensory block assessed by pin-prick', 'timeFrame': '0-36 hours', 'description': 'Duration is defined as time from block performance until recovery of normal sensation, assessed on the hour post block (except at 2 and 3 hours post block where there will be a break and no assessments will be performed).'}, {'measure': 'Difference between dexamethasone and placebo in the duration of a sensory block assessed as maximum pain during a tonic heat stimulation test', 'timeFrame': '0-36 hours', 'description': 'Duration is defined as time from block performance until recovery of normal sensation, assessed on the hour post block (except at 2 and 3 hours post block where there will be a break and no assessments will be performed).\n\nRecovery of normal sensation is defined as VAS pain scores ± 10 mm of the pre-block value.'}, {'measure': 'Difference between dexamethasone and placebo in the duration of a sensory block assessed as warmth detection threshold', 'timeFrame': '0-36 hours', 'description': 'Duration is defined as time from block performance until recovery of normal sensation, assessed on the hour post block (except at 2 and 3 hours post block where there will be a break and no assessments will be performed and only assessed if pain scores during tonic heat stimulation is above 0 ).\n\nRecovery of normal sensation is defined as detection thresholds of ± 2 degrees C of the pre-block value.'}, {'measure': 'Difference between dexamethasone and placebo in the duration of a sensory block assessed as heat pain detection threshold', 'timeFrame': '0-36 hours', 'description': 'Duration is defined as time from block performance until recovery of normal sensation, assessed on the hour post block (except at 2 and 3 hours post block where there will be a break and no assessments will be performed and only assessed if pain scores during tonic heat stimulation is above 0 ).\n\nRecovery of normal sensation is defined as detection thresholds of ± 2 degrees C of the pre-block value.'}, {'measure': 'Difference in maximum pain scores between dexamethasone and placebo during block and after recovery of normal sensation', 'timeFrame': '0-36 hours', 'description': 'Pain scores during a tonic heat stimulation will be compared at 4 h post block and 1 h after pain scores have returned to the pre-block values.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['US-guided peripheral nerve block', 'Anesthetics, Local', 'duration', 'Sensation', 'adductor canal block', 'lower limb', 'Adjuvants, Anesthesia'], 'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate whether dexamethasone as an adjuvant to ropivacaine for adductor canal block increases duration of the sensory block, when controlling for a systemic effect using a paired design and bilateral blocks.\n\nThe investigators hypothesize that adding dexamethasone to ropivacaine will prolong block duration compared with ropivacaine + placebo.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists class 1\n* Body Mass Index 18-30\n\nExclusion Criteria:\n\n* Allergy to study medication\n* Earlier trauma or surgery to lower limb\n* Diabetes Mellitus\n* Alcohol or drug abuse\n* Daily intake of opioids or steroids last 4 weeks\n* Daily intake of any analgesics last 48 hours'}, 'identificationModule': {'nctId': 'NCT02351804', 'briefTitle': 'Does Perineural Dexamethasone Prolong Duration of a Nerve Block?', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Does Perineural Dexamethasone Prolong Duration of an Adductor Canal Block When Controlling for a Systemic Effect? A Paired, Randomized, Blinded, Study in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'SM2-PJ-14'}, 'secondaryIdInfos': [{'id': '2014-004879-23', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ropivacaine + dexamethasone', 'description': '20 ml ropivacaine 0.5% + 0.5 ml dexamethasone 4 mg7ml', 'interventionNames': ['Drug: Ropivacaine + dexamethasone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Ropivacaine + placebo', 'description': '20 ml ropivacaine 0.5% + 0.5 ml isotonic saline ad', 'interventionNames': ['Drug: Ropivacaine + placebo']}], 'interventions': [{'name': 'Ropivacaine + dexamethasone', 'type': 'DRUG', 'description': 'Adductor canal block, single bolus', 'armGroupLabels': ['Ropivacaine + dexamethasone']}, {'name': 'Ropivacaine + placebo', 'type': 'DRUG', 'description': 'Adductor canal block, single bolus', 'armGroupLabels': ['Ropivacaine + placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2900', 'city': 'Gentofte Municipality', 'state': 'Hellerup', 'country': 'Denmark', 'facility': 'Department of Anaesthesia-Surgery-Intensive Care, Gentofte Hospital', 'geoPoint': {'lat': 55.74903, 'lon': 12.54601}}], 'overallOfficials': [{'name': 'Pia Jæger, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rigshospitalet, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Coordinating Investigator', 'investigatorFullName': 'Pia Jaeger', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}