Ignite Creation Date:
2025-12-24 @ 10:36 PM
Ignite Modification Date:
2025-12-31 @ 12:28 AM
Study NCT ID:
NCT00724035
Status:
COMPLETED
Last Update Posted:
2009-07-15
First Post:
2008-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound-Guided Axillary or Infraclavicular Nerve Block for Upper Limb Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D005543', 'term': 'Forearm Injuries'}], 'ancestors': [{'id': 'D001134', 'term': 'Arm Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008874', 'term': 'Midazolam'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D011292', 'term': 'Premedication'}, {'id': 'D000077212', 'term': 'Ropivacaine'}, {'id': 'D000779', 'term': 'Anesthetics, Local'}, {'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D000701', 'term': 'Analgesics, Opioid'}, {'id': 'D000700', 'term': 'Analgesics'}, {'id': 'D000768', 'term': 'Anesthesia, General'}, {'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D019220', 'term': 'High-Energy Shock Waves'}], 'ancestors': [{'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D000777', 'term': 'Anesthetics'}, {'id': 'D002492', 'term': 'Central Nervous System Depressants'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D018689', 'term': 'Sensory System Agents'}, {'id': 'D018373', 'term': 'Peripheral Nervous System Agents'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D009294', 'term': 'Narcotics'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D000069453', 'term': 'Ultrasonic Waves'}, {'id': 'D013016', 'term': 'Sound'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-07-14', 'studyFirstSubmitDate': '2008-07-25', 'studyFirstSubmitQcDate': '2008-07-25', 'lastUpdatePostDateStruct': {'date': '2009-07-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Onset time of brachial plexus sensory block', 'timeFrame': 'q5min up to 30 min after the block'}], 'secondaryOutcomes': [{'measure': 'Onset of brachial plexus motor block', 'timeFrame': 'q5min up to 30 min after the block'}, {'measure': 'Patient satisfaction (3-point scale)', 'timeFrame': 'End of surgery'}, {'measure': 'Anesthesia-related procedural pain (0-10 numerical rating scale)', 'timeFrame': 'End of block placement'}, {'measure': 'Rescue analgesic requirements during surgery', 'timeFrame': 'During surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Anesthesia', 'Upper extremity', 'Nerve block', 'Ultrasound', 'Brachial plexus'], 'conditions': ['Upper Extremity', 'Orthopedic Surgery', 'Trauma', 'Forearm Injuries', 'Nerve Block']}, 'descriptionModule': {'briefSummary': 'This study aims to detect differences in onset time of brachial plexus (i.e., arm) anesthesia using two different nerve block techniques.\n\nUsing ultrasound guidance, axillary (i.e., at the armpit) and infraclavicular (i.e., below the collarbone) blocks will be performed to patients undergoing upper limb surgery.\n\nThe investigators will analyze how long it takes for anesthesia to be adequate for pain-free surgery, thus determine the optimal technique for this kind of surgery.', 'detailedDescription': 'Real-time ultrasound guidance has substantially reduced the risk of pneumothorax and/or vascular puncture during infraclavicular brachial plexus blocks. The role of this technique has thus been expanded to overlap those procedures for which an axillary nerve block would be commonly considered as first choice.\n\nA reference block for upper limb surgery thanks to its safety profile and clinical efficacy, the axillary approach may be more painful or unpleasant for some patients.\n\nThe investigators aim to determine possible differences in onset time and patient acceptance between the two techniques.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA Physical Status Class \\<4\n* Scheduled upper extremity orthopedic surgery\n\nExclusion Criteria:\n\n* Psychiatric or cognitive disorder\n* Allergy to study drugs\n* Contraindication to nerve block at the assigned site'}, 'identificationModule': {'nctId': 'NCT00724035', 'briefTitle': 'Ultrasound-Guided Axillary or Infraclavicular Nerve Block for Upper Limb Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Parma'}, 'officialTitle': 'Onset Time of Brachial Plexus Anesthesia With the Axillary or Infraclavicular Approach Under Real-Time Ultrasound Guidance: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'ANEST-ORT-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Infraclavicular', 'description': 'This group will receive an ultrasound-guided infraclavicular brachial plexus block.', 'interventionNames': ['Drug: Midazolam', 'Drug: Ropivacaine', 'Drug: Fentanyl', 'Procedure: General anesthesia', 'Procedure: Infraclavicular brachial plexus block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Axillary', 'description': 'This group will receive an ultrasound-guided axillary brachial plexus block.', 'interventionNames': ['Drug: Midazolam', 'Drug: Ropivacaine', 'Drug: Fentanyl', 'Procedure: General anesthesia', 'Procedure: Axillary brachial plexus nerve block']}], 'interventions': [{'name': 'Midazolam', 'type': 'DRUG', 'otherNames': ['Versed', 'Benzodiazepine', 'Premedication', 'Sedation'], 'description': 'Procedural sedation before the execution of the block.\n\n* 0.03 mg/kg iv bolus', 'armGroupLabels': ['Axillary', 'Infraclavicular']}, {'name': 'Ropivacaine', 'type': 'DRUG', 'otherNames': ['Naropin', 'Local anesthetic', 'Amide local anesthetic'], 'description': '0.75% (wt/vol) solution, 20 ml perineural injection', 'armGroupLabels': ['Axillary', 'Infraclavicular']}, {'name': 'Fentanyl', 'type': 'DRUG', 'otherNames': ['Opioid', 'Analgesic'], 'description': '50 µg iv bolus prn for pain during surgery, up to 150 µg', 'armGroupLabels': ['Axillary', 'Infraclavicular']}, {'name': 'General anesthesia', 'type': 'PROCEDURE', 'otherNames': ['Monitored anesthesia care'], 'description': 'General anesthesia will be induced if pain during surgery develops which is intractable with iv fentanyl ≤150 µg.', 'armGroupLabels': ['Axillary', 'Infraclavicular']}, {'name': 'Axillary brachial plexus nerve block', 'type': 'PROCEDURE', 'otherNames': ['Peripheral Nerve Block', 'Regional Anesthesia', 'Ultrasound'], 'description': 'Blocks will be performed under high-resolution real-time ultrasound guidance.\n\nPatients will be in the supine position. With the abducted arm flexed 90° at the elbow, the transducer will scan for the axillary artery in its short-axis. Individual nerves will be sought for around the artery.\n\nA 22G, 17°-bevel needle will be advanced in-plane to inject aliquots of local anesthetic around each nerve structure up to the prescribed dose.', 'armGroupLabels': ['Axillary']}, {'name': 'Infraclavicular brachial plexus block', 'type': 'PROCEDURE', 'otherNames': ['Regional Anesthesia', 'Peripheral nerve block', 'Ultrasound'], 'description': 'Blocks will be performed under high-resolution real-time ultrasound guidance.\n\nPatients will be in the supine position. The linear transducer will be initially positioned between the middle and lateral third of the clavicle, scanning on a parasagittal plane.\n\nThe axillary artery and veins will then be sought for. We will try to visualize the three cords of the brachial plexus separately, and to inject local anesthetic around each of them. If this is not possible, the needle will be positioned cranially and posteriorly to the artery, and the injection will be made from there. A 20 G, 17°-bevel needle will be used for all blocks.', 'armGroupLabels': ['Infraclavicular']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43100', 'city': 'Parma', 'state': 'PR', 'country': 'Italy', 'facility': 'University Hospital / Azienda Ospedaliero-Universitaria', 'geoPoint': {'lat': 44.79935, 'lon': 10.32618}}], 'overallOfficials': [{'name': 'Guido Fanelli, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Section of Anesthesiology and Critical Care, Dept. of Surgical Sciences, University of Parma'}, {'name': 'Giorgio Danelli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UO II Anestesia e Rianimazione, Azienda Ospedaliero-Universitaria di Parma'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Parma', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Guido Fanelli, MD', 'oldOrganization': 'University of Parma'}}}}