Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2025-12-27 @ 5:05 AM
Study NCT ID:
NCT04567992
Status:
COMPLETED
Last Update Posted:
2022-02-14
First Post:
2020-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Ultrasound Guided Superficial Cervical Plexus Block for Tracheal Reconstruction Surgery:
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-11', 'studyFirstSubmitDate': '2020-09-24', 'studyFirstSubmitQcDate': '2020-09-26', 'lastUpdatePostDateStruct': {'date': '2022-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'quality of recovery using quality of recovery 40 qusetionnaire', 'timeFrame': 'first 24 hour', 'description': 'total score of Qor-40 (total score of 200) with highest indicates better outcome'}], 'secondaryOutcomes': [{'measure': 'post operative morphine consumption', 'timeFrame': '24 hour', 'description': 'post operative morphine consumption'}, {'measure': 'visual analogue scale post-operative', 'timeFrame': 'first 24 hour', 'description': 'visual analogue scale post-operative'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Efficiency of Using Ultrasound-guided SCB for Providing Intra and Postoperative Analgesiatracheal Reconstruction Surgery']}, 'descriptionModule': {'briefSummary': 'The essential goal for tracheal reconstruction is is the ability of the anaesthesiologist and surgeon to maintain control of the airway at all times. In the postoperative period the patient should maintain a flexed neck position to avoid any traction on the tracheal anastomosis. Thus, pain control is essential postoperatively so that patients will be awake and cooperative to maintain this position. \\[1\\].\n\nSuperficial cervical plexus block can be used in a variety of surgical procedures , including superficial surgery on the neck and shoulders and thyroid surgery as it results in anesthesia of the skin of the anterolateral neck and the ante-auricular and retro-auricular areas, as well as the skin overlying and immediately inferior to the clavicle on the chest wall Figures 1 and 6)\\[2\\].\n\nThus it can be used as an adjuvant to general anaesthesia to provide analgesia for patients undergoing tracheal resection and anastomosis to keep the patients awake and cooperative at the conclusion of the procedure.\n\nThe goal of the ultrasound (US)-guided technique of SCB is to deposit local anesthetic within the vicinity of the sensory branches of the nerve roots C2, C3, and C4 which combine to form the four terminal branches (the lesser occipital, greater auricular, transverse cervical, and supraclavicular nerves) and emerge from behind the posterior border of the SCM. Advantages over the landmark-based technique include the ability to visualize the spread of local anesthetic in the correct plane, which therefore increases the success rate, and to avoid a needle insertion that is too deep and the inadvertent puncture of neighboring structures\\[3\\].\n\nAim of the work To assess the efficiency of using ultrasound-guided SCB for providing intra and postoperative analgesia for patients undergoing tracheal resection and anastomosis under general anaesthesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• ASA physical status I, II, and III adult patients undergoing elective tracheal resection and anastomosis under general anaesthesia were included.\n\nExclusion Criteria:\n\n* Coagulation disorders\n* Pregnancy.\n* Age less than 18 years.\n* Patient refusal.\n* Emergency re-operation within'}, 'identificationModule': {'nctId': 'NCT04567992', 'briefTitle': 'Efficacy of Ultrasound Guided Superficial Cervical Plexus Block for Tracheal Reconstruction Surgery:', 'organization': {'class': 'OTHER', 'fullName': 'Kasr El Aini Hospital'}, 'officialTitle': 'Efficacy of Ultrasound Guided Superficial Cervical Plexus Block for Tracheal Reconstruction Surgery on Quality of Recovery: a Randomized Control Study', 'orgStudyIdInfo': {'id': 'MS-106-2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SCPB', 'interventionNames': ['Procedure: superficial cervical plexus block']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'interventionNames': ['Procedure: superficial cervical plexus block']}], 'interventions': [{'name': 'superficial cervical plexus block', 'type': 'PROCEDURE', 'otherNames': ['Drug:', 'Bupivicaine'], 'description': 'ultrasound guided injection of local anaesthesia in the superficial cervical plexus', 'armGroupLabels': ['Control', 'SCPB']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12566', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Kasr alainy medical school', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kasr El Aini Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of anaesthesia, SICU and pain management', 'investigatorFullName': 'Ayman Abougabal', 'investigatorAffiliation': 'Kasr El Aini Hospital'}}}}