Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT04694105
Status:
COMPLETED
Last Update Posted:
2021-01-05
First Post:
2020-12-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Peri-neural Dexmedetomidine Versus Dexamethasone for Supraaclavicular Block Adjuvant to Bupivacaine Supraclavicular Brachial Plexus Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'double blind both anesthetist and patient not aware about type of local anesthesia'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel Assignment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-01-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-04', 'studyFirstSubmitDate': '2020-12-18', 'studyFirstSubmitQcDate': '2021-01-04', 'lastUpdatePostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of analgesia', 'timeFrame': '"UP to 4 hours post operative"', 'description': '(time in hours to the first report of postoperative pain at the surgical site, administered of opioid when VAS score was\\>4).'}], 'secondaryOutcomes': [{'measure': 'Pain scores.', 'timeFrame': '"at 8 and 24 hours post operative"', 'description': 'Severity of pain at the surgical site (VAS) score'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dexmedetomidine', 'dexamethasone'], 'conditions': ['Brachial Plexus Block']}, 'referencesModule': {'references': [{'pmid': '17865904', 'type': 'RESULT', 'citation': 'Kulenkampff D. BRACHIAL PLEXUS ANAESTHESIA: ITS INDICATIONS, TECHNIQUE, AND DANGERS. Ann Surg. 1928 Jun;87(6):883-91. doi: 10.1097/00000658-192806000-00015. No abstract available.'}, {'pmid': '26695877', 'type': 'RESULT', 'citation': 'Neal JM. Ultrasound-Guided Regional Anesthesia and Patient Safety: Update of an Evidence-Based Analysis. Reg Anesth Pain Med. 2016 Mar-Apr;41(2):195-204. doi: 10.1097/AAP.0000000000000295.'}, {'pmid': '23513068', 'type': 'RESULT', 'citation': 'Ji F, Li Z, Nguyen H, Young N, Shi P, Fleming N, Liu H. Perioperative dexmedetomidine improves outcomes of cardiac surgery. Circulation. 2013 Apr 16;127(15):1576-84. doi: 10.1161/CIRCULATIONAHA.112.000936. Epub 2013 Mar 19.'}]}, 'descriptionModule': {'briefSummary': 'to assessthe impact of addition of Dexmedetomidine or Dexamethasone to Bupivacaine, on Duration of analgesia (time in hours to the first report of postoperative pain )at the surgical site', 'detailedDescription': 'This randomized, controlled double blinded study included 42 adult patients undergoing arteriovenous fistula surgery. Ultrasound-guided supraclavicular brachial plexus block was initiated after placement of full monitoring . Supraclavicular brachial plexus block was achieved with the use of total volume 32 ml of anesthetic drugs in all patients. Bupivacaine 30 ml 0.25% was combined with 2 ml normal saline (control group A, n=14), Bupivacaine 30 ml 0.25% was combined with 50 microgram (0.5 ml) peri-neural dexmedetomidine plus 1.5 ml normal saline ( dexmedetomidine group B ,n=14), or Bupivacaine 30 ml 0.25% was combined with 4 mg peri neural dexamethasone (2 ml) ( dexamethasone group C, n=14).The onset and duration of sensory and motor blocks, the time to first request to postoperative rescue analgesic, Richmond Agitation-Sedation Score, hemodynamic data, visual analogue pain scores, were reported at predetermined time assessment points. Postoperative rescue intravenous fentanyl consumption over 24 hours and complications occurred were recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All the patients included in the study aged 18 to 60 years old were on chronic hemodialysis and they had a hemodialysis session one day before the block performance\n\nExclusion Criteria:\n\n* Neurological, neuromuscular, psychiatric disorders, hepatic, respiratory, or cardiac diseases; coagulation disorders; infection at the block injection site; patients with a body mass index more than 35; or patients who refused the procedure'}, 'identificationModule': {'nctId': 'NCT04694105', 'briefTitle': 'Peri-neural Dexmedetomidine Versus Dexamethasone for Supraaclavicular Block Adjuvant to Bupivacaine Supraclavicular Brachial Plexus Block', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Peri-neural Dexmedetomidine Versus Dexamethasone as an Adjuvant to Bupivacaine Single Injection in Ultrasoundguided Supraclavicular Brachial Plexus Block for Arteriovenous Fistula: A Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'regional block adjuvants'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'dexmedetomidine', 'description': 'Bupivacaine 30 ml 0.25% was combined with 50 microgram (0.5 ml) peri-neural dexmedetomidine plus 1.5 ml normal saline', 'interventionNames': ['Drug: Dexmedetomidine injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'dexamethasone', 'description': 'Bupivacaine 30 ml 0.25% was combined with 4 mg peri neural dexamethasone (2 ml)', 'interventionNames': ['Drug: Dexamethasone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control group', 'description': 'Bupivacaine 30 ml 0.25% was combined with 2 ml normal saline', 'interventionNames': ['Drug: saline']}], 'interventions': [{'name': 'Dexmedetomidine injection', 'type': 'DRUG', 'otherNames': ['precedex'], 'description': 'perineural injection of Bupivacaine 30 ml 0.25% combined with 50 microgram (0.5 ml) peri-neural dexmedetomidine plus 1.5 ml normal saline', 'armGroupLabels': ['dexmedetomidine']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'otherNames': ['decadrone'], 'description': 'perineural injection of Bupivacaine 30 ml 0.25% combined with 4 mg peri neural dexamethasone (2 ml)', 'armGroupLabels': ['dexamethasone']}, {'name': 'saline', 'type': 'DRUG', 'otherNames': ['normal saline'], 'description': 'perineural injection of Bupivacaine 30 ml 0.25% combined with 2 ml normal saline', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11451', 'city': 'Cairo', 'state': 'Giza Governorate', 'country': 'Egypt', 'facility': 'Kasr Alini Univeristy Hospital'}], 'overallOfficials': [{'name': 'Tarek A Radwan, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of intensive care unit at new kaser al ainy teaching hospital , lecterur of anaesthesia and intensive care cairo universty', 'investigatorFullName': 'mahmoud salem soliman', 'investigatorAffiliation': 'Cairo University'}}}}