Ignite Creation Date:
2025-12-24 @ 5:46 PM
Ignite Modification Date:
2025-12-25 @ 3:13 PM
Study NCT ID:
NCT03767868
Status:
COMPLETED
Last Update Posted:
2019-04-11
First Post:
2018-12-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Indicator of Successful Peripheral Nerve Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001832', 'term': 'Body Temperature Changes'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2019-03-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-10', 'studyFirstSubmitDate': '2018-12-05', 'studyFirstSubmitQcDate': '2018-12-05', 'lastUpdatePostDateStruct': {'date': '2019-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Differences in the color of nail polish', 'timeFrame': '30 minutes', 'description': 'The photographs showing if there is the reaction of color of nail polish will be assessed after study completion by independent observers. They will be asked to compare the colors of nail polish before and after block performance in both hands and to rate the difference based on a three-point scale (0: absolutely no difference, 1: I am not sure, 2: indisputable difference).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Temperature Change, Body']}, 'referencesModule': {'references': [{'pmid': '31592901', 'type': 'DERIVED', 'citation': 'Kavakli AS, Enginar F, Arslan U, Ozdemir F. Thermochromic nail polish as a novel indicator to predict infraclavicular brachial plexus block success: A prospective cohort study. Eur J Anaesthesiol. 2019 Dec;36(12):911-917. doi: 10.1097/EJA.0000000000001091.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study was to investigate whether a color changing nail polish would be an indicator to assess infraclavicular brachial plexus block success based on skin temperature differences before and after performed the block.', 'detailedDescription': 'After performed the block, sensory and motor block assessments will be carried out by blinded observer every 5 min after needle removal for 30 min in the regions of the radial, median, ulnar, and musculocutaneous nerves of the forearm. Skin temperature measurements will be performed from both the anesthetized side and the contralateral arm before the procedure and every 5 min for 30 min by a blinded observer. Before the block, the color changing nail polish will be applied to all hand nails of the patient. An independent observer will photograph the reaction of the nail polish (i.e. color change) in both hands immediately after application of nail polish and at two minute intervals for 30 min after performing the block. Two blinded observers were reviewed the digital photographs. They were asked to compare the colors of nail polish in both hands and to score the difference based on a three-point scale (0: absolutely no difference, 1: I am not sure, 2: indisputable difference)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adults between 18 and 65 years of age with infraclavicular brachial lexus block for elective elbow, forearm, wrist, or hand surgery , were selected in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who received infraclavicular brachial plexus block for elective elbow, forearm, wrist, or hand surgery\n* American Society of Anesthesiologists class I, II or III\n\nExclusion Criteria:\n\n* patients \\<18 years old\n* \\>65 years old\n* body mass index (BMI) \\<20 or \\>35 kg/m2\n* inability to provide written informed consent\n* refusal of regional anesthesia\n* pregnancy\n* contraindication for regional anesthesia\n* peripheral neurological disease,\n* Raynaud disease'}, 'identificationModule': {'nctId': 'NCT03767868', 'briefTitle': 'An Indicator of Successful Peripheral Nerve Block', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Antalya Training and Research Hospital'}, 'officialTitle': 'A Different Indicator of Successful Peripheral Nerve Block', 'orgStudyIdInfo': {'id': 'AntalyaTRH27'}}, 'armsInterventionsModule': {'interventions': [{'name': 'color change in nail polish', 'type': 'OTHER', 'description': 'The determination of color change in nail polish will be based on differences in skin temperature before and after the block.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Antalya', 'country': 'Turkey (Türkiye)', 'facility': 'Antalya Training and Research Hospital', 'geoPoint': {'lat': 36.90812, 'lon': 30.69556}}], 'overallOfficials': [{'name': 'Ali Sait Kavakli, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Antalya Training and Research Hospital'}, {'name': 'Ulku Arslan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karabuk University'}, {'name': 'Ferhat Enginar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Antalya Training and Research Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Antalya Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}