Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
Study NCT ID:
NCT06847620
Status:
COMPLETED
Last Update Posted:
2025-02-26
First Post:
2025-01-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Verapamil as an Adjuvant to Local Anaethetics in Supraclav Block for Hand Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D012847', 'term': 'Single Person'}, {'id': 'D014700', 'term': 'Verapamil'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D017533', 'term': 'Marital Status'}, {'id': 'D005191', 'term': 'Family Characteristics'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-25', 'studyFirstSubmitDate': '2025-01-05', 'studyFirstSubmitQcDate': '2025-02-25', 'lastUpdatePostDateStruct': {'date': '2025-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary outcome measure', 'timeFrame': 'The duration from giving the block till the need of rescue analgesia in post op 24 hours', 'description': 'Duration between performing the block and the need of rescue analgesia in patients receiving ultrasound-guided supraclavicular Brachial plexus block with bupivacaine as sole agent versus bupivacaine and verapamil.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hand Surgery']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the role of verapamil when added to bupivacaine in ultrasound-giuded supraclavicular Brachial plexus block regarding the duration of action of the block, onset of action and the need of rescue analgesia.', 'detailedDescription': 'Preoperative Period All patients will clinically be assessed and routine preoperative investigations will be done: Complete blood picture, Coagulation profile, liver function tests, kidney function tests, fasting blood sugar and ECG. The initial vital data will be measured after applying the standard monitoring including pulse oximetry, non-invasive blood pressure and ECG. All patients will be admitted after fasting for 6 hours.\n\nIntraoperative Period On arrival of the patients to the operative room, electrocardiography, non-invasive blood pressure, and pulse oximetry will be applied. Baseline parameters such as systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP), heart rate (HR), and oxygen saturation (SpO2) will be recorded. Intravenous (IV) line will be inserted and IV lactated Ringer will be started.\n\nThe block will be performed using a portable ultrasound system (sonosite M-turbo USA) with linear high-frequency transducer (12HZ) to get the sonographic anatomy of brachial plexus in the transverse and longitudinal planes.\n\nUnder aseptic conditions, the ultrasound probe will be situated parallel to the clavicle in the supraclavicular area to show the plexus as a "bunch of grapes" or as having a "honeycomb" appearance. The block will be done with a short beveled echogenic needle 5 cm, 22 G for optimal control and visibility. The predetermined volume of 22 ml will be injected around the brachial plexus after negative aspiration to avoid inadvertent intravascular injection keeping in mind adequate block of lower trunk. Distension of brachial plexus sheath will be regarded as an indication of successful block "Donut sign". A massage for 5 min will be applied to aid an equal volume distribution.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females aged 21-70 years old\n* Patients with ASA I / II\n* patients undergoing hand surgeries\n\nExclusion Criteria:\n\n* Patients refusal\n* Skin infection at the injection site.\n* Contraindications to regional anaesthesia as bleeding disorders\n* Allergy to bupivacaine or other drugs involved in the study.\n* Uncooperative patients.\n* BMI \\>35\n* Patients taking medications for psychiatric illness'}, 'identificationModule': {'nctId': 'NCT06847620', 'briefTitle': 'Effect of Verapamil as an Adjuvant to Local Anaethetics in Supraclav Block for Hand Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Evaluation of the Effect of Verapamil When Added to Bupivacaine in Ultrasound-guided Supraclavicular Block in Hand Surgeries', 'orgStudyIdInfo': {'id': 'FMASU MS165/2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '• Group A (the control group)', 'description': 'group A: will receive 20 ml of plain bupivacaine 0.25% (equivalent to 50 mg) plus 2 ml of normal saline.', 'interventionNames': ['Procedure: Supraclavicular Brachial Plexus Block', 'Drug: Bupivacaine 0.25% 20ml alone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', 'description': 'Group B : will receive 20 ml of bupivacaine 0.25% (equivalent to 50 mg) plus 2 ml verapamil (equivalent to 5 mg)', 'interventionNames': ['Procedure: Supraclavicular Brachial Plexus Block', 'Drug: bupivacaine 0.25% And verapamil']}], 'interventions': [{'name': 'Supraclavicular Brachial Plexus Block', 'type': 'PROCEDURE', 'description': 'The block will be performed using a portable ultrasound system (sonosite M-turbo USA) with linear high-frequency transducer (12HZ) to get the sonographic anatomy of brachial plexus in the transverse and longitudinal planes.', 'armGroupLabels': ['Group B', '• Group A (the control group)']}, {'name': 'Bupivacaine 0.25% 20ml alone', 'type': 'DRUG', 'description': 'will receive 20 ml of plain bupivacaine 0.25% (equivalent to 50 mg) plus 2 ml of normal saline.', 'armGroupLabels': ['• Group A (the control group)']}, {'name': 'bupivacaine 0.25% And verapamil', 'type': 'DRUG', 'description': 'will receive 20 ml of bupivacaine 0.25% (equivalent to 50 mg) plus 2 ml verapamil (equivalent to 5 mg', 'armGroupLabels': ['Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11111', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain Shams University Hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Before 2/2025', 'ipdSharing': 'YES', 'accessCriteria': 'Free'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}