Ignite Creation Date:
2025-12-24 @ 4:41 PM
Ignite Modification Date:
2025-12-28 @ 8:42 AM
Study NCT ID:
NCT04487366
Status:
UNKNOWN
Last Update Posted:
2020-07-27
First Post:
2020-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single and Double Operator Techniques in Ultrasound-guided Peripheral Nerve Block Learning Curve
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-22', 'studyFirstSubmitDate': '2020-07-17', 'studyFirstSubmitQcDate': '2020-07-22', 'lastUpdatePostDateStruct': {'date': '2020-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to correct grip1', 'timeFrame': 'during implementation of procedure on phantom model(first session)', 'description': 'Time(sec) from start command to correct grip of the probe, needle and syringe for each technique'}, {'measure': 'image quality1', 'timeFrame': 'during implementation of procedure on phantom model(first session)', 'description': 'provided image quality by resident for each technique which is assessed by investigator by four point Liker Scale( 1- much worse 2- worse 3- better 4- much better)'}, {'measure': 'number of attempts1', 'timeFrame': 'during implementation of procedure on phantom model(first session)', 'description': 'number of attempts until correct needling to target area'}, {'measure': 'needling time 1', 'timeFrame': 'during implementation of procedure on phantom model(first session)', 'description': 'time to reach target area with block needle'}, {'measure': 'success of injection1', 'timeFrame': 'during implementation of procedure on phantom model(first session)', 'description': 'successful if injected water flows from hose of model/ unsuccessful if solution do not flow'}, {'measure': 'Time to correct grip2', 'timeFrame': 'during implementation of procedure on phantom model(second session)', 'description': 'Time(sec) from start command to correct grip of the probe, needle and syringe for each technique'}, {'measure': 'Time to correct grip3', 'timeFrame': 'during implementation of procedure on phantom model(third session)', 'description': 'Time(sec) from start command to correct grip of the probe, needle and syringe for each technique'}, {'measure': 'image quality2', 'timeFrame': 'during implementation of procedure on phantom model(second session)', 'description': 'provided image quality by resident for each technique which is assessed by investigator by four point Liker Scale( 1- much worse 2- worse 3- better 4- much better)'}, {'measure': 'image quality3', 'timeFrame': 'during implementation of procedure on phantom model(third session)', 'description': 'provided image quality by resident for each technique which is assessed by investigator by four point Liker Scale( 1- much worse 2- worse 3- better 4- much better)'}, {'measure': 'number of attempts2', 'timeFrame': 'during implementation of procedure on phantom model(second session)', 'description': 'number of attempts until correct needling to target area'}, {'measure': 'number of attempts3', 'timeFrame': 'during implementation of procedure on phantom model(third session)', 'description': 'number of attempts until correct needling to target area'}, {'measure': 'needling time 2', 'timeFrame': 'during implementation of procedure on phantom model(second session)', 'description': 'time to reach target area with block needle'}, {'measure': 'needling time 3', 'timeFrame': 'during implementation of procedure on phantom model(third session)', 'description': 'time to reach target area with block needle'}, {'measure': 'success of injection2', 'timeFrame': 'during implementation of procedure on phantom model(second session)', 'description': 'successful if injected water flows from hose of model/ unsuccessful if solution do not flow'}, {'measure': 'success of injection3', 'timeFrame': 'during implementation of procedure on phantom model(third session)', 'description': 'successful if injected water flows from hose of model/ unsuccessful if solution do not flow'}], 'secondaryOutcomes': [{'measure': 'NASA-TLX (NASA Task Load Index)', 'timeFrame': 'during implementation of procedure on phantom model(third session)', 'description': 'Resident assessment of each techniques for Mental Demand ,Physical Demand, Temporal Demand, Performance, Effort and Frustration'}, {'measure': 'Assesment of education', 'timeFrame': 'during education of techniques', 'description': 'Residents assesment of pre-procedural education with a questtionarie. "Education was sufficient enough to safely perform peripheral block":\n\n1. I absolutely agree\n2. I approve\n3. I am indecisive\n4. I do not approve\n5. Absolutely Disagree'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Jedi Grip', 'single-operator ultrasound-guided regional anaesthesia grip', 'Single-handed ultrasound-guided regional anaesthesia', "'On lock' grip", 'Anesthesiology training'], 'conditions': ['Single-handed Ultrasound-guided Regional Anaesthesia Grip', 'Single-operator Ultrasound-guided Peripheric Nerve Block', 'Anesthesiology Training', 'Jedi Grip']}, 'referencesModule': {'references': [{'pmid': '21831086', 'type': 'BACKGROUND', 'citation': 'Pappin D, Christie I. The Jedi Grip: a novel technique for administering local anaesthetic in ultrasound-guided regional anaesthesia. Anaesthesia. 2011 Sep;66(9):845. doi: 10.1111/j.1365-2044.2011.06845.x. No abstract available.'}, {'pmid': '28891057', 'type': 'BACKGROUND', 'citation': "Gupta P, Berrill A. 'On lock' - a further single-operator ultrasound-guided regional anaesthesia grip. Anaesthesia. 2017 Oct;72(10):1289. doi: 10.1111/anae.14050. No abstract available."}, {'pmid': '21831088', 'type': 'BACKGROUND', 'citation': 'Bedforth N, Townsley P, Maybin J, Eisenberg E. Single-handed ultrasound-guided regional anaesthesia. Anaesthesia. 2011 Sep;66(9):846. doi: 10.1111/j.1365-2044.2011.06864.x. No abstract available.'}, {'pmid': '9431583', 'type': 'BACKGROUND', 'citation': 'Miyake S. Factors influencing mental workload indexes. J UOEH. 1997 Dec 1;19(4):313-25. doi: 10.7888/juoeh.19.313.'}, {'pmid': '36107586', 'type': 'DERIVED', 'citation': 'Guven Aytac B, Unal S, Aytac I. A randomized, controlled simulation study comparing single and double operator ultrasound-guided regional nerve block techniques using a gelatine-based home-made phantom. Medicine (Baltimore). 2022 Sep 2;101(35):e30368. doi: 10.1097/MD.0000000000030370.'}]}, 'descriptionModule': {'briefSummary': 'Aim of this study is to compare learning curves of single(1- Jedi grip: Pappin and Christie/ 2- Bedforth/ 3- on lock: Gupta and Berrill) and double operator ultrasound-guided peripheric nerve block techniques on a home-made gelatin-based phantom model.', 'detailedDescription': 'Ultrasound-guided peripheral blocks are conventionaly performed by double operators. One operator controls both the ultrasound probe and peripheric block needle. Another assistant operator aspirate or injects local anesthetic. In this technique operator do not sense resistance in the syringe. Also this technique requires a well-done communication and coordination between operators.\n\nIn order to eliminate disadvantages of this technique several single-operator grip techniques of the needle and syringe have been described(1- Jedi grip: Pappin and Christie/ 2- Bedforth/ 3- on lock: Gupta and Berrill). Single operator techniques allow the provider to perform independently.\n\nAim of this study is to compare learning curves of single and double operator ultrasound-guided peripheric nerve block techniques on a home-made gelatin-based phantom model.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '24 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- To be a junior resident of anesthesiology(\\< 2 years )\n\nExclusion Criteria:\n\n* Refusal of resident'}, 'identificationModule': {'nctId': 'NCT04487366', 'briefTitle': 'Single and Double Operator Techniques in Ultrasound-guided Peripheral Nerve Block Learning Curve', 'organization': {'class': 'OTHER', 'fullName': 'Ankara City Hospital Bilkent'}, 'officialTitle': 'Comparison of Single and Double Operator Techniques in Ultrasound-guided Peripheral Nerve Block Learning Curve for Anesthesia Residency Training on a Gelatin-based Phantom Model: a Prospective Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'E1/20-804'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Double Operator Ultrasound-Guided Regional Anesthesia', 'description': 'resident control block needle and ultrasound probe and asistant operator inject the solution. resident reach the target area created in the phantom model using a block needle with ultrasound guidance', 'interventionNames': ['Other: reaching targeted area on the phantom model']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Jedi Grip', 'description': 'resident control block needle, ultrasound probe and syringe independently with jedi grip; reach the target area created in the phantom model using a block needle with ultrasound guidance; inject and aspirate the solution.', 'interventionNames': ['Other: reaching targeted area on the phantom model']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'On-lock grip', 'description': 'resident control block needle, ultrasound probe and syringe independently with on-lock grip; reach the target area created in the phantom model using a block needle with ultrasound guidance; inject the solution.', 'interventionNames': ['Other: reaching targeted area on the phantom model']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bedforth alternative grip', 'description': "resident control block needle, ultrasound probe and syringe independently with bedforth's alternative grip; reach the target area created in the phantom model using a block needle with ultrasound guidance; inject the solution.", 'interventionNames': ['Other: reaching targeted area on the phantom model']}], 'interventions': [{'name': 'reaching targeted area on the phantom model', 'type': 'OTHER', 'description': 'resident reach the targeted area on the phantom model using ultrasoun guidance and independently or with asistance inject the solution', 'armGroupLabels': ['Bedforth alternative grip', 'Double Operator Ultrasound-Guided Regional Anesthesia', 'Jedi Grip', 'On-lock grip']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06600', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara City Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'İsmail Aytac', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ankara City Hospital Anesthesiology Department'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara City Hospital Bilkent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'ismail aytaç', 'investigatorAffiliation': 'Ankara City Hospital Bilkent'}}}}