Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-01-05 @ 1:03 PM
Study NCT ID:
NCT03346993
Status:
COMPLETED
Last Update Posted:
2017-11-20
First Post:
2017-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Can Latency of Action in Infraclavicular Brachial Plexus Block be Shortened With Warmed Bupivacaine?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-16', 'studyFirstSubmitDate': '2017-11-08', 'studyFirstSubmitQcDate': '2017-11-16', 'lastUpdatePostDateStruct': {'date': '2017-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Evaluate sensory block's onset time", 'timeFrame': '30 minutes after Brachial Plexus Block', 'description': 'Pain was evaluated by pinprick test (yes-there is a pain/ no-there is no pain)'}], 'secondaryOutcomes': [{'measure': "Evaluate motor block's onset times", 'timeFrame': '30 minutes after Brachial Plexus Block', 'description': 'Motion on distal arm was evaluated by bromage scale (0- full flexion of distal arm, 3-unable to move distal arm)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bupivacaine', 'Brachial Plexus Block', 'Ultrasound'], 'conditions': ['Effect Increased']}, 'descriptionModule': {'briefSummary': 'Brachial plexus blocks have some advantages, but also have some disadvantages as well. As with all nerve blocks, having to wait sometime for an effective block, sometimes failure to achieve an adequate block and possible requirement for isolated nerve block, having to wait a long time for resolution of the block, and immobilization of the extremity for some time can be seen as handicaps for brachial plexus block as well. In the present study, Study was aimed to compare the effects of bupivacaine warmed to body temperature and kept at room temperature on the onset time of ultrasound guided infraclavicular brachial plexus block.', 'detailedDescription': 'The study design was approved by the locale ethics committee. This double-blinded, randomized, controlled clinical trial recruited 60 patients aged between 18 and 65 years with the American society of anesthesiologists (ASA) physical status classification systems I/II and III who were candidated for surgical operations on any of the forearm, wrist and hand regions. All the participants were asked to sign an informed consent form after having been provided with details of the aim and proceedings of the study.\n\nPatients were excluded from the study if they had a neurological and neuromuscular disorders, psychiatric problems, cardiopulmonary diseases, coagulopathy, infections or allergy to local anesthetic agents.\n\nThe patients were equally and randomly distributed into a 24C° 20 ml 0,5% bupivacaine group (Group 1), and 37C° 20 ml 0,5% bupivacaine group (Group 2) via closed envelope technique. All the participants were premedicated with 0.05 mg/kg of intravenous midazolam and monitored routinely before attempting nerve block.\n\nBupivacaine stored for at least 2 hours in a bain-marie (Memmert Waterbath WNB7, Germany) at 38˚C (regular temperature calibration was made) for Group 2.\n\nThe block process was accomplished by an anesthesiologist, who was blind to the temperature of bupivacaine and local anesthetic agent was administered by different anesthesiologist.\n\nAt the end of the ICBP block, an anesthetist blinded to the technique evaluated sensory and motor block in every minutes between 5th and 30th minutes as follows. The innervated areas (each dermatome) was evaluated using a pinprick test. The motor block was evaluated by bromage modified scale in every minutes between 10th and 30th minutes. Anxious patients were administered additional midazolam. Subjects refusing awake surgery were administered a propofol infusion with supplemental oxygen as necessary.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients aged between 18 and 65 years\n2. American society of anesthesiologists (ASA) physical status classification systems I/II and III\n3. Candidate for surgical operations on any of the forearm, wrist and hand regions.\n\nExclusion Criteria:\n\n1. Neurological and neuromuscular disorders,\n2. Psychiatric problems\n3. Cardiopulmonary diseases\n4. Coagulopathy\n5. Infections\n6. Sllergy to local anesthetic agents.'}, 'identificationModule': {'nctId': 'NCT03346993', 'briefTitle': 'Can Latency of Action in Infraclavicular Brachial Plexus Block be Shortened With Warmed Bupivacaine?', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Erzurum Palandöken State Hospital'}, 'officialTitle': 'Can Latency of Action in Infraclavicular Brachial Plexus Block be Shortened With Warmed Bupivacaine?', 'orgStudyIdInfo': {'id': 'Palandöken State Hospital'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '24C° 0,5% bupivacaine group', 'description': '24C° 0,5% bupivacaine group will be performed USG guided infraclavicular block with 24C° 20 ml 0,5% bupivacaine', 'interventionNames': ['Drug: Bupivacaine Hydrochloride 5 MG/ML']}, {'type': 'EXPERIMENTAL', 'label': '37C° 0,5% bupivacaine group', 'description': '37C° 0,5% bupivacaine group will be performed USG guided infraclavicular block with 37C° 20 ml 0,5% bupivacaine', 'interventionNames': ['Drug: Bupivacaine Hydrochloride 5 MG/ML']}], 'interventions': [{'name': 'Bupivacaine Hydrochloride 5 MG/ML', 'type': 'DRUG', 'description': 'Ultrasound guided infraclavicular brachial plexus block with warmed bupivacaine', 'armGroupLabels': ['24C° 0,5% bupivacaine group', '37C° 0,5% bupivacaine group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25080', 'city': 'Erzurum', 'country': 'Turkey (Türkiye)', 'facility': 'Palandöken State Hospital', 'geoPoint': {'lat': 39.90861, 'lon': 41.27694}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erzurum Palandöken State Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consult of Anesthesiologhy', 'investigatorFullName': 'Erkan Cem ÇELİK', 'investigatorAffiliation': 'Erzurum Palandöken State Hospital'}}}}