Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2026-01-05 @ 12:42 AM
Study NCT ID:
NCT03385967
Status:
WITHDRAWN
Last Update Posted:
2019-05-23
First Post:
2017-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Duration of Analgesia With Dexmedetomidine and Ropivacaine in Brachial Plexus Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D059787', 'term': 'Acute Pain'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D000077212', 'term': 'Ropivacaine'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'Double Blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a prospective, randomized, double blind study of adding dexmedetomidine 0.25mcg/kg body weight to standard dose (25ml) of 0.5%ropivacaine for Brachial plexus block and assessing the analgesia with VAS pain scales (0-10), Satisfaction scale by VAS scale (0-10) and time to first analgesic consumption.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'PI is leaving the University of Florida', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-05-21', 'studyFirstSubmitDate': '2017-12-20', 'studyFirstSubmitQcDate': '2017-12-27', 'lastUpdatePostDateStruct': {'date': '2019-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of Effect', 'timeFrame': 'Immediate pre-op until 36hours post block', 'description': 'To determine the change in duration of analgesia by the time to first intake of analgesic medicine by adding 0.25mcg/kg of dexmedetomidine to 25 ml of 0.5%ropivacaine in Brachial plexus nerve block.'}], 'secondaryOutcomes': [{'measure': 'Potential Side Effects', 'timeFrame': 'Immediate pre-op until 36hours post block', 'description': 'To look for the potential side effects of dexmedetomidine like bradycardia and hypotension in the intraoperative and immediate post-operative period.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['upper extremity bone fracture'], 'conditions': ['Analgesia', 'Pain, Acute', 'Peripheral Nerve Block']}, 'descriptionModule': {'briefSummary': 'This is a prospective, randomized, double blind study of adding dexmedetomidine to ropivacaine for Brachial plexus block and assessing the analgesia with VAS pain scales(0-10), Satisfaction scale by VAS scale(0-10) and time to first analgesic consumption. This study mainly aims to investigate whether addition of dexmedetomidine helps in increasing the duration of analgesia.', 'detailedDescription': 'In our institute ropivacaine is used for all the peripheral nerve blocks. This a prospective, randomized, double blind clinical trial study comparing the addition of dexmedetomidine vs ropivacaine alone in brachial plexus nerve block. After screening the patient with the inclusion criteria, an informed consent is obtained from the patient by one of the co-investigator.\n\nAdjuvants to local anesthetics are commonly added to prolong the duration of the peripheral nerve block. Sometimes patients have other added comorbidities along with high BMI with history of chronic pain where prolonging the duration of the peripheral nerve block would help with decreased narcotic consumption in the perioperative period with minimal side effects related to the local anesthetics(LA) as well as the adjuncts.\n\nDexmedetomidine is proven to be better than Clonidine in a recent study. Also perineural dexmedetomidine is proven to be more efficacious compared to intravenous dosing. The investigators are evaluating whether adding dexmedetomidine to standard dose of Ropivacaine helps in prolonging the duration of the peripheral nerve block with minimal side effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age-18years and above\n* Both male and female patients\n* BMI-\\>18\n* Elective Subacute upper extremity fractures\n\nExclusion Criteria:\n\n* Chronic pain patients (Pain persisting for more than 3-6months or past the normal healing time of any injury, influences every aspect of a person's quality of life.)\n* Patients with drug abuse history in the past 6 months\n* ESRD\n* Hepatic failure"}, 'identificationModule': {'nctId': 'NCT03385967', 'briefTitle': 'Duration of Analgesia With Dexmedetomidine and Ropivacaine in Brachial Plexus Block', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'A Randomized, Prospective, Double Blind Clinical Trial to Investigate the Increase in Duration of Analgesia With Addition of 0.25mcg/kg of Dexmedetomidine (DEX) to 25 ml of 0.5%Ropivacaine in Supraclavicular Brachial Plexus Block.', 'orgStudyIdInfo': {'id': 'IRB201702926'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ropivacaine only', 'description': '0.5% ropivacaine', 'interventionNames': ['Drug: ropivacaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ropivacaine with dexmedetomidine', 'description': '25ml of 0.5%ropivacaine with 0.25mcg/kg of dexmedetomidine', 'interventionNames': ['Drug: Dexmedetomidine', 'Drug: ropivacaine']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'otherNames': ['precedex'], 'description': 'Addition of Dexmedetomidine in block .25mcg/kg of dexmedetomidine', 'armGroupLabels': ['ropivacaine with dexmedetomidine']}, {'name': 'ropivacaine', 'type': 'DRUG', 'otherNames': ['naropin'], 'description': 'Standard of care 0.5%ropivacaine', 'armGroupLabels': ['ropivacaine only', 'ropivacaine with dexmedetomidine']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Alberto Ardon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida College of Medicine Jacksonville'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}