Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2025-12-29 @ 5:30 AM
Study NCT ID:
NCT03207035
Status:
COMPLETED
Last Update Posted:
2021-10-18
First Post:
2017-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Local Anaesthetic Dilution on the Characteristics of Ultrasound Guided Axillary Brachial Plexus Block
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'drmrak.2@gmail.com', 'title': 'Dr Anil Ranganath', 'organization': 'Cork University Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 day', 'description': 'The incidence of adverse effects perioperatively: nausea, dizziness, tinnitus, vomiting, convulsions or arrhythmia.', 'eventGroups': [{'id': 'EG000', 'title': '20 ml of Lidocaine 2% With Epinephrine', 'description': 'Patients will receive axillary brachial plexus block with 20 ml of lidocaine 2% with epinephrine.\n\nAxillary brachial plexus block: Ultrasound guided axillary brachial plexus block with local anaesthetic lidocaine with epinephrine', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '40 ml 0f Lidocaine 1% With Epinephrine', 'description': 'Patients will receive axillary brachial plexus block with 20 ml of lidocaine 1% with epinephrine diluted with 20 ml of nacl 0.9% ( total 40 ml)\n\nAxillary brachial plexus block: Ultrasound guided axillary brachial plexus block with local anaesthetic lidocaine with epinephrine', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Onset of Axillary Block', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '20 ml of Lidocaine 2% With Epinephrine', 'description': 'Patients will receive axillary brachial plexus block with 20 ml of lidocaine 2% with epinephrine.\n\nAxillary brachial plexus block: Ultrasound guided axillary brachial plexus block with local anaesthetic lidocaine with epinephrine'}, {'id': 'OG001', 'title': '40 ml 0f Lidocaine 1% With Epinephrine', 'description': 'Patients will receive axillary brachial plexus block with 20 ml of lidocaine 1% with epinephrine diluted with 20 ml of nacl 0.9% ( total 40 ml)\n\nAxillary brachial plexus block: Ultrasound guided axillary brachial plexus block with local anaesthetic lidocaine with epinephrine'}], 'classes': [{'categories': [{'measurements': [{'value': '8.75', 'groupId': 'OG000', 'lowerLimit': '7.5', 'upperLimit': '10'}, {'value': '6.25', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '7.5'}]}]}], 'analyses': [{'pValue': '0.03', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': '1 day', 'description': 'Time taken for onset of sensory and motor axillary brachial plexus block', 'unitOfMeasure': 'minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of Sensory and Motor Block', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '20 ml of Lidocaine 2% With Epinephrine', 'description': 'Patients will receive axillary brachial plexus block with 20 ml of lidocaine 2% with epinephrine.\n\nAxillary brachial plexus block: Ultrasound guided axillary brachial plexus block with local anaesthetic lidocaine with epinephrine'}, {'id': 'OG001', 'title': '40 ml 0f Lidocaine 1% With Epinephrine', 'description': 'Patients will receive axillary brachial plexus block with 20 ml of lidocaine 1% with epinephrine diluted with 20 ml of nacl 0.9% ( total 40 ml)\n\nAxillary brachial plexus block: Ultrasound guided axillary brachial plexus block with local anaesthetic lidocaine with epinephrine'}], 'classes': [{'categories': [{'measurements': [{'value': '165.1', 'spread': '5.9', 'groupId': 'OG000'}, {'value': '150.9', 'spread': '17.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': '1 day', 'description': 'Total duration of sensory and motor block of ultrasound guided axillary brachial plexus block', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Block Performance Data- Imaging Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '20 ml of Lidocaine 2% With Epinephrine', 'description': 'Patients will receive axillary brachial plexus block with 20 ml of lidocaine 2% with epinephrine.\n\nAxillary brachial plexus block: Ultrasound guided axillary brachial plexus block with local anaesthetic lidocaine with epinephrine'}, {'id': 'OG001', 'title': '40 ml 0f Lidocaine 1% With Epinephrine', 'description': 'Patients will receive axillary brachial plexus block with 20 ml of lidocaine 1% with epinephrine diluted with 20 ml of nacl 0.9% ( total 40 ml)\n\nAxillary brachial plexus block: Ultrasound guided axillary brachial plexus block with local anaesthetic lidocaine with epinephrine'}], 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '0.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.70', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': '1 Hour', 'description': 'Time taken to obtain appropriate ultrasound image to perform the axillary plexus block', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Needling Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '20 ml of Lidocaine 2% With Epinephrine', 'description': 'Patients will receive axillary brachial plexus block with 20 ml of lidocaine 2% with epinephrine.\n\nAxillary brachial plexus block: Ultrasound guided axillary brachial plexus block with local anaesthetic lidocaine with epinephrine'}, {'id': 'OG001', 'title': '40 ml 0f Lidocaine 1% With Epinephrine', 'description': 'Patients will receive axillary brachial plexus block with 20 ml of lidocaine 1% with epinephrine diluted with 20 ml of nacl 0.9% ( total 40 ml)\n\nAxillary brachial plexus block: Ultrasound guided axillary brachial plexus block with local anaesthetic lidocaine with epinephrine'}], 'classes': [{'categories': [{'measurements': [{'value': '8.5', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '6.7', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': '1Hour', 'description': 'Time taken to perform the block in minutes', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Performance Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '20 ml of Lidocaine 2% With Epinephrine', 'description': 'Patients will receive axillary brachial plexus block with 20 ml of lidocaine 2% with epinephrine.\n\nAxillary brachial plexus block: Ultrasound guided axillary brachial plexus block with local anaesthetic lidocaine with epinephrine'}, {'id': 'OG001', 'title': '40 ml 0f Lidocaine 1% With Epinephrine', 'description': 'Patients will receive axillary brachial plexus block with 20 ml of lidocaine 1% with epinephrine diluted with 20 ml of nacl 0.9% ( total 40 ml)\n\nAxillary brachial plexus block: Ultrasound guided axillary brachial plexus block with local anaesthetic lidocaine with epinephrine'}], 'classes': [{'categories': [{'measurements': [{'value': '10.9', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '9.1', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': '1 Hour', 'description': 'Sum of imaging and performance time', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'No of Needle Pass', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '20 ml of Lidocaine 2% With Epinephrine', 'description': 'Patients will receive axillary brachial plexus block with 20 ml of lidocaine 2% with epinephrine.\n\nAxillary brachial plexus block: Ultrasound guided axillary brachial plexus block with local anaesthetic lidocaine with epinephrine'}, {'id': 'OG001', 'title': '40 ml 0f Lidocaine 1% With Epinephrine', 'description': 'Patients will receive axillary brachial plexus block with 20 ml of lidocaine 1% with epinephrine diluted with 20 ml of nacl 0.9% ( total 40 ml)\n\nAxillary brachial plexus block: Ultrasound guided axillary brachial plexus block with local anaesthetic lidocaine with epinephrine'}], 'classes': [{'categories': [{'measurements': [{'value': '10.5', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '9.1', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': '1 Hour', 'description': 'Number of needle passes while performing the axillary block', 'unitOfMeasure': 'Needle passes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Vascular Puncture', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '20 ml of Lidocaine 2% With Epinephrine', 'description': 'Patients will receive axillary brachial plexus block with 20 ml of lidocaine 2% with epinephrine.\n\nAxillary brachial plexus block: Ultrasound guided axillary brachial plexus block with local anaesthetic lidocaine with epinephrine'}, {'id': 'OG001', 'title': '40 ml 0f Lidocaine 1% With Epinephrine', 'description': 'Patients will receive axillary brachial plexus block with 20 ml of lidocaine 1% with epinephrine diluted with 20 ml of nacl 0.9% ( total 40 ml)\n\nAxillary brachial plexus block: Ultrasound guided axillary brachial plexus block with local anaesthetic lidocaine with epinephrine'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.53', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '1 Hour', 'description': 'Incidence of vascular puncture during the performance of block.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Parasthesia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '20 ml of Lidocaine 2% With Epinephrine', 'description': 'Patients will receive axillary brachial plexus block with 20 ml of lidocaine 2% with epinephrine.\n\nAxillary brachial plexus block: Ultrasound guided axillary brachial plexus block with local anaesthetic lidocaine with epinephrine'}, {'id': 'OG001', 'title': '40 ml 0f Lidocaine 1% With Epinephrine', 'description': 'Patients will receive axillary brachial plexus block with 20 ml of lidocaine 1% with epinephrine diluted with 20 ml of nacl 0.9% ( total 40 ml)\n\nAxillary brachial plexus block: Ultrasound guided axillary brachial plexus block with local anaesthetic lidocaine with epinephrine'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.48', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '1 Hour', 'description': 'Incidence of parasthesia during the performance of axillary block', 'unitOfMeasure': 'Parasthesia events', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '20 ml of Lidocaine 2% With Epinephrine', 'description': 'Patients will receive axillary brachial plexus block with 20 ml of lidocaine 2% with epinephrine.\n\nAxillary brachial plexus block: Ultrasound guided axillary brachial plexus block with local anaesthetic lidocaine with epinephrine'}, {'id': 'FG001', 'title': '40 ml 0f Lidocaine 1% With Epinephrine', 'description': 'Patients will receive axillary brachial plexus block with 20 ml of lidocaine 1% with epinephrine diluted with 20 ml of nacl 0.9% ( total 40 ml)\n\nAxillary brachial plexus block: Ultrasound guided axillary brachial plexus block with local anaesthetic lidocaine with epinephrine'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Enrollment\n\nAssessed for eligibility: n=45 Excluded : n= 25\n\n* Not meeting inclusion criteria: n = 5\n* Declined to participate: n = 20\n\nRandomized: n= 20'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '20 ml of Lidocaine 2% With Epinephrine', 'description': 'Patients will receive axillary brachial plexus block with 20 ml of lidocaine 2% with epinephrine.\n\nAxillary brachial plexus block: Ultrasound guided axillary brachial plexus block with local anaesthetic lidocaine with epinephrine'}, {'id': 'BG001', 'title': '40 ml 0f Lidocaine 1% With Epinephrine', 'description': 'Patients will receive axillary brachial plexus block with 20 ml of lidocaine 1% with epinephrine diluted with 20 ml of nacl 0.9% ( total 40 ml)\n\nAxillary brachial plexus block: Ultrasound guided axillary brachial plexus block with local anaesthetic lidocaine with epinephrine'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.8', 'spread': '18.2', 'groupId': 'BG000'}, {'value': '48', 'spread': '15.7', 'groupId': 'BG001'}, {'value': '47.4', 'spread': '16.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Ireland', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2016-03-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-14', 'studyFirstSubmitDate': '2017-05-07', 'resultsFirstSubmitDate': '2021-08-07', 'studyFirstSubmitQcDate': '2017-06-30', 'lastUpdatePostDateStruct': {'date': '2021-10-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-10-14', 'studyFirstPostDateStruct': {'date': '2017-07-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Onset of Axillary Block', 'timeFrame': '1 day', 'description': 'Time taken for onset of sensory and motor axillary brachial plexus block'}], 'secondaryOutcomes': [{'measure': 'Duration of Sensory and Motor Block', 'timeFrame': '1 day', 'description': 'Total duration of sensory and motor block of ultrasound guided axillary brachial plexus block'}, {'measure': 'Block Performance Data- Imaging Time', 'timeFrame': '1 Hour', 'description': 'Time taken to obtain appropriate ultrasound image to perform the axillary plexus block'}, {'measure': 'Needling Time', 'timeFrame': '1Hour', 'description': 'Time taken to perform the block in minutes'}, {'measure': 'Performance Time', 'timeFrame': '1 Hour', 'description': 'Sum of imaging and performance time'}, {'measure': 'No of Needle Pass', 'timeFrame': '1 Hour', 'description': 'Number of needle passes while performing the axillary block'}, {'measure': 'Vascular Puncture', 'timeFrame': '1 Hour', 'description': 'Incidence of vascular puncture during the performance of block.'}, {'measure': 'Parasthesia', 'timeFrame': '1 Hour', 'description': 'Incidence of parasthesia during the performance of axillary block'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Brachial Plexus Blockade']}, 'descriptionModule': {'briefSummary': 'We propose to compare the effects of local anaesthetic dilution on the characteristics of the ultrasound guided axillary brachial plexus block.\n\nAdministration of 40ml lidocaine 1% with epinephrine will shorten the onset time of ultrasound guided axillary brachial plexus block when compared to 20 mL lidocaine 2% with epinephrine for elective upper limb surgical procedures.', 'detailedDescription': "To compare the effects of local anaesthetic 20 mL lidocaine 1% with epinephrine vs 40 mL lidocaine 1% with epinephrine on the onset of sensory and motor block following ultrasound guided axillary brachial plexus block.\n\nMethods:\n\nIt is a prospective, randomized, observer blinded study. With institutional ethical approval and having obtained written informed consent from each, 20 patients will be studied.\n\nRandomisation and blinding:\n\nUsing a computer generated and sealed envelope technique, 20 patients will be randomly allocated in to one of two groups.\n\nGroup 1: patients will receive 20 ml of lidocaine 2% with epinephrine. Group 2: patients will receive 40 ml of lidocaine 1% with epinephrine.\n\nSample size and statistical analysis:\n\nIn the absence of data from previous study using 20 ml of lidocaine with epinephrine for ultrasound guided axillary brachial plexus block. Sample size was calculated based on from our pilot study of 12 patients. We found mean onset of block of 11.25 (SD, 2.3) mins. The minimum sample size required to have an 80% probability of detecting a 30% decrease in onset time (level of significance 0.05) will be 7 patients per group using an unpaired student's t test. Recruited 10 per group\n\nAnaesthetic procedure:\n\nHaving established intravenous access, standard anaesthetic monitoring will be applied. Premedication with midazolam will be administered as clinically indicated (to a maximum of 3 mg). The operative arm will be abducted and externally rotated with elbow flexed at 90 degrees. Under strict aseptic condition, ultrasound guided axillary brachial plexus block will be performed. Having identified musculocutaneous, median, radial and ulnar nerves, a 50mm 24-gauge stimuplex short bevel insulated needle will be used with in-plane approach to block each nerve with either 5 (Group 1) or 10 ml (Group 2). All blocks will be performed by operator experienced in the ultrasound peripheral nerve blocks.\n\nBlock assessment:\n\nWhen the block procedure has been completed, a blinded observer will assess the onset of sensory and motor block in the innervation of each nerve every 2.5 mins, until surgical anaesthesia is achieved or 30 mins have elapsed (Table 1). Surgical anaesthesia will be defined as a motor score ≤2, with absent sensation to cold and pinprick. Each nerve distribution will be individually assessed. Onset time will be measured from conclusion of the block (t=0) to attainment of surgical anaesthesia. Block will be deemed failure if surgical anaesthesia has not been achieved at 30 mins in one or more of the four nerve distribution. In case of failure, an additional rescue block or conversion to general anaesthesia will be performed. DATA from these patients will be analysed separately.\n\nIntraoperative period:\n\nAll patients will receive 1 g of paracetamol and diclofenac 75 mg iv during surgery. In case of patients discomfort sedation and rescue analgesia in the form of fentanyl 25 micrograms aliquots IV will be administered to a maximum of 100 micrograms.\n\nPostoperative period:\n\nUpon arrival to recovery room, sensory and motor function will be assessed every 15 mins by a blinded observer.15 Assessment will be performed for each nerve separately. Block regression is defined as a return of sensation to cold and pinprick with motor power score ≥3 in any nerve region. Time to first request for postoperative analgesia and total opioid consumption for 24 hrs will be noted. Postoperative analgesia will be prescribed as paracetamol 1 g 6 hourly and diclofenac sodium 75 mg 12 hourly. Oxycodone 5-10 mg orally 4-6 hourly will be administered as rescue analgesia.\n\nPrimary Outcome: onset of block.\n\nSecondary Outcomes: Duration of sensory and motor block and block performance data (Imaging time, Needling time, Performance time, No of needle pass, Vascular puncture and parasthesia)"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA 1-3\n* Patients aged \\>18 years undergoing elective upper limb (forearm or hand) surgical procedures.\n\nExclusion Criteria:\n\n* Contraindications to regional anaesthesia\n* Hypersensitivity to amide local anaesthetics.\n* Chronic pain\n* Language barrier\n* Neuromuscular disorders or peripheral neuropathy\n* Body mass index \\> 35\n* History of hepatic and renal insufficiency\n* Pregnancy\n* Cognitive or psychiatric disorder\n* Cardiac conduction abnormality.'}, 'identificationModule': {'nctId': 'NCT03207035', 'briefTitle': 'Effect of Local Anaesthetic Dilution on the Characteristics of Ultrasound Guided Axillary Brachial Plexus Block', 'organization': {'class': 'OTHER', 'fullName': 'Cork University Hospital'}, 'officialTitle': 'Effect of Local Anaesthetic Dilution on the Characteristics of Ultrasound Guided Axillary Brachial Plexus Block', 'orgStudyIdInfo': {'id': 'ECM 4 (mm)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '20 ml of lidocaine 2% with epinephrine', 'description': 'Patients will receive axillary brachial plexus block with 20 ml of lidocaine 2% with epinephrine.', 'interventionNames': ['Procedure: Axillary brachial plexus block']}, {'type': 'EXPERIMENTAL', 'label': '40 ml 0f lidocaine 1% with epinephrine', 'description': 'Patients will receive axillary brachial plexus block with 20 ml of lidocaine 1% with epinephrine diluted with 20 ml of nacl 0.9% ( total 40 ml)', 'interventionNames': ['Procedure: Axillary brachial plexus block']}], 'interventions': [{'name': 'Axillary brachial plexus block', 'type': 'PROCEDURE', 'description': 'Ultrasound guided axillary brachial plexus block with local anaesthetic lidocaine with epinephrine', 'armGroupLabels': ['20 ml of lidocaine 2% with epinephrine', '40 ml 0f lidocaine 1% with epinephrine']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Anil Ranganath, FCAI', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cork University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cork University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr (Fellow in Regional Anaesthesia)', 'investigatorFullName': 'Dr Anil Ranganath', 'investigatorAffiliation': 'Cork University Hospital'}}}}