Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2026-02-24 @ 10:52 AM
Study NCT ID:
NCT01620112
Status:
COMPLETED
Last Update Posted:
2012-06-15
First Post:
2012-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Different Clonidine Concentrations on Axillary Brachial Plexus Block With 1,5% Lidocaine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002037', 'term': 'Bundle-Branch Block'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D006327', 'term': 'Heart Block'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-14', 'studyFirstSubmitDate': '2012-06-09', 'studyFirstSubmitQcDate': '2012-06-14', 'lastUpdatePostDateStruct': {'date': '2012-06-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sensorial and motor block duration', 'timeFrame': '24 hours after surgery', 'description': 'to compare two concentrations of clonidine on different volumes of lidocaine, in terms of sensorial and motor block duration'}], 'secondaryOutcomes': [{'measure': 'adverse effects of additive clonidine on axillary brachial plexus block in upper limb surgery', 'timeFrame': '24 hours after surgery', 'description': 'analyse the adverse effects of additive clonidine on axillary brachial plexus block in upper limb surgery'}, {'measure': 'postoperative analgesia duration', 'timeFrame': '24 hours', 'description': 'to compare two concentrations of clonidine on different volumes of lidocaine, in terms of postoperative analgesia duration'}, {'measure': 'sensorial and motor block onset time', 'timeFrame': '24 hours', 'description': 'to compare two concentrations of clonidine on different volumes of lidocaine, in terms of sensorial and motor block onset time'}, {'measure': 'postoperative pain intensity', 'timeFrame': '24 hours', 'description': 'to compare two concentrations of clonidine on different volumes of lidocaine, in terms postoperative pain intensity'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['brachial plexus', 'lidocaine', 'alfa 2 adrenergic receptor clonidine', 'orthopedic procedure'], 'conditions': ['Fascicular Block', 'Motor Activity', 'Pain, Postoperative', 'Latency Period']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether different clonidine concentration on axillary brachial plexus block with 1,5% lidocaine for upper limb surgery may influence the sensory and motor block onset time and duration, postoperative analgesia duration, postoperative pain intensity', 'detailedDescription': "Brachial plexus blocks are frequently used in surgical procedures involving the upper limb because they facilitate surgical anaesthesia, muscle relaxation and post-operative analgesics.\n\nVarious drugs are used to supplement local anaesthetics during brachial plexus block. Many studies in the literature show that clonidine, which is an alpha-2 agonist, prolongs the length of anesthesia and post-operative analgesia.4,5 However, clonidine's side effects-such as hypotension, bradycardia and sedation can limit its use.\n\nThere are no studies comparing different clonidine concentrations on the axillary brachial block, so the hypothesis of the present study was that different clonidine concentrations and LA volumes may influence the anaesthesia and analgesia quality on this type of regional block."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* both genders,\n* over 18 years old,\n* American Society of Anesthesiologists (ASA) 1 to 3\n\nExclusion Criteria:\n\n* patients with chronic use of analgesics and non-steroidal anti-inflammatories drugs,\n* pregnant,\n* with infection at the puncture site,\n* coagulopathies or intolerance to drugs used in the study'}, 'identificationModule': {'nctId': 'NCT01620112', 'briefTitle': 'The Effects of Different Clonidine Concentrations on Axillary Brachial Plexus Block With 1,5% Lidocaine', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Federal do Rio de Janeiro'}, 'officialTitle': 'The Effects of Different Clonidine Concentrations on Axillary Brachial Plexus Block With 1,5% Lidocaine for Upper Limb Surgery: a Prospective Randomized Study', 'orgStudyIdInfo': {'id': '090/2002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'low clonidine concentration', 'description': 'clonidine concentration 1 ml on 40 ml of lidocaine 1.5% for upper brachial plexus', 'interventionNames': ['Drug: low clonidine concentration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'lidocaine 20 ml 1,5%', 'description': 'lidocaine 20 ml 1,5% without clonidine for axillary brachial plexus block for upper limb surgery', 'interventionNames': ['Drug: Lidocaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'high clonidine concentration', 'description': 'clonidine concentration 150 mcg on 20 ml of lidocaine 1,5% for upper brachial plexus', 'interventionNames': ['Drug: high Clonidine concentration']}, {'type': 'ACTIVE_COMPARATOR', 'label': '40 ml lidocaine 1,5%', 'description': '40 ml of lidocaine 1,5% without clonidine for upper brachial plexus', 'interventionNames': ['Drug: Lidocaine 40 ml']}], 'interventions': [{'name': 'high Clonidine concentration', 'type': 'DRUG', 'description': 'Clonidine 1 ml - 150 mcg on 20 ml de lidocaine 1,5% on axillary brachial plexus block for upper limb surgery', 'armGroupLabels': ['high clonidine concentration']}, {'name': 'low clonidine concentration', 'type': 'DRUG', 'description': 'Clonidine 1 ml - 150 mcg on 40 ml of lidocaine 1,5% - single injection on axillary brachial plexus block for upper limb', 'armGroupLabels': ['low clonidine concentration']}, {'name': 'Lidocaine', 'type': 'DRUG', 'description': 'Lidocaine 1,5% 20 ml 300 mg for single injection on axillary brachial plexus block for upper lim surgery', 'armGroupLabels': ['lidocaine 20 ml 1,5%']}, {'name': 'Lidocaine 40 ml', 'type': 'DRUG', 'description': 'Lidocaine 40 ml 1,5% 600 mg single injection for axillary brachial plexus block for upper limb surgery', 'armGroupLabels': ['40 ml lidocaine 1,5%']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Federal do Rio de Janeiro', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assad AR', 'investigatorFullName': 'Alexandra Rezende Assad', 'investigatorAffiliation': 'Universidade Federal do Rio de Janeiro'}}}}