Ignite Creation Date:
2025-12-24 @ 2:07 PM
Ignite Modification Date:
2025-12-27 @ 9:31 PM
Study NCT ID:
NCT05686395
Status:
COMPLETED
Last Update Posted:
2024-12-19
First Post:
2023-01-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pain Control After Arthroscopic Shoulder Surgeries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-08-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-16', 'studyFirstSubmitDate': '2023-01-06', 'studyFirstSubmitQcDate': '2023-01-13', 'lastUpdatePostDateStruct': {'date': '2024-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'post operative analgesic consumption', 'timeFrame': '24 hours after surgery', 'description': 'The first 24 hours post operative analgesic consumption'}], 'secondaryOutcomes': [{'measure': 'Visual Analogue score (VAS) in the first 24 hours after surgery', 'timeFrame': 'first 24 hours after surgery', 'description': '\\- Postoperative pain intensity will be assessed in the first 24 hour using VAS score where (0 = no pain and 100 = the worst imaginable pain)'}, {'measure': 'Patient satisfaction score', 'timeFrame': 'first 24 hours after surgery', 'description': 'Patient satisfaction score will be assessed on the basis of a questionnaire and graded on a 4-point scale (excellent/good/fair/poor).'}, {'measure': 'The incidence of hemi diaphragmatic paralysis', 'timeFrame': 'immediately before block and immediately after procedure', 'description': 'hemidiaphragmatic paralysis after block'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post Operative Pain']}, 'descriptionModule': {'briefSummary': 'This study will be conducted to compare the perioperative analgesic efficacy of ultrasound - guided interscalene brachial plexus block versus combined shoulder anterior capsular block and anterior suprascapular nerve block for arthroscopic shoulder surgeries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 20-65 years of both sexes, with American Society of Anesthesiologists (ASA) physical status I or II admitted for arthroscopic shoulder surgery.\n\nExclusion Criteria:\n\n* Patient refusal.\n* Uncooperative patient.\n* Patient with neurological deficit.\n* Patients with respiratory disorders.\n* Patient with bleeding disorders.\n* Infection at the block injection site.\n* Patients with history of allergy to local anesthetics.'}, 'identificationModule': {'nctId': 'NCT05686395', 'briefTitle': 'Pain Control After Arthroscopic Shoulder Surgeries', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Comparative Study of Analgesic Efficacy of Ultrasound Guided Interscalene Block Versus Combined Shoulder Anterior Capsular Block and Suprascapular Nerve Block for Arthroscopic Shoulder Surgeries.', 'orgStudyIdInfo': {'id': 'IRB0010038'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'group 1 Ultrasound-guided Interscalene Block group', 'description': 'In this group, ultrasound-guided ISB will be done using 10 ml of bupivacaine 0.25%.', 'interventionNames': ['Procedure: Ultrasound-guided Interscalene Block group', 'Drug: Bupivacaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group 2 Combined Ultrasound guided shoulder anterior capsular block and suprascapular nerve block', 'description': ', ultrasound-guided SHAC block will be done using 10 ml of bupivacaine 0.25% injected in the interfacial plane between deltoid and subscapular muscle and 10 ml of bupivacaine 0.25% injected in the pericapsular space. Ultrasound-guided SSN block will be done using 10 ml of bupivacaine 0.25% injected at sub omohyoid space.', 'interventionNames': ['Procedure: Combined Ultrasound guided shoulder anterior capsular block and suprascapular nerve block', 'Drug: Bupivacaine']}], 'interventions': [{'name': 'Ultrasound-guided Interscalene Block group', 'type': 'PROCEDURE', 'description': 'ultrasound guided interscalene block versus combined ultrasound guided shoulder anterior capsular block and suprascapular nerve block for arthroscopic shoulder surgery', 'armGroupLabels': ['group 1 Ultrasound-guided Interscalene Block group']}, {'name': 'Combined Ultrasound guided shoulder anterior capsular block and suprascapular nerve block', 'type': 'PROCEDURE', 'description': 'Combined Ultrasound guided shoulder anterior capsular block and suprascapular nerve block', 'armGroupLabels': ['group 2 Combined Ultrasound guided shoulder anterior capsular block and suprascapular nerve block']}, {'name': 'Bupivacaine', 'type': 'DRUG', 'description': 'bupivacaine 0.25%.', 'armGroupLabels': ['group 1 Ultrasound-guided Interscalene Block group', 'group 2 Combined Ultrasound guided shoulder anterior capsular block and suprascapular nerve block']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tanta', 'country': 'Egypt', 'facility': 'Faculty of Medicine Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'ASSISTANT LECTURER OF ANESTHESIA AND INTENSIVE CARE AND PAIN MEDICINE', 'investigatorFullName': 'Hosameldin Ibrahim Ibrahim Elsayed Eldib', 'investigatorAffiliation': 'Tanta University'}}}}