Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2026-03-03 @ 4:14 AM
Study NCT ID:
NCT05646667
Status:
COMPLETED
Last Update Posted:
2024-03-26
First Post:
2022-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interscalene Block Alone Versus Interscalene Block With Erector Spinae Plane Block for Shoulder Arthroscopy Anesthesia
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': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-25', 'studyFirstSubmitDate': '2022-12-04', 'studyFirstSubmitQcDate': '2022-12-09', 'lastUpdatePostDateStruct': {'date': '2024-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraoperative fentanyl consumption', 'timeFrame': 'Intraoperative up to 4 hours', 'description': 'If the patient complains of pain during surgery, fentanyl will be administered 1 µg/kg IV increments.'}], 'secondaryOutcomes': [{'measure': 'Amount of 24hrs postoperative rescue analgesic consumption', 'timeFrame': '24 hours postoperatively', 'description': 'Intravenous meperidine (0.5 mg/kg) will be administered if numerical pain rating scale (NRS) score of more than 3.'}, {'measure': 'Degree of pain by Numerical pain rating scale', 'timeFrame': '24 hours postoperatively', 'description': 'Postoperative pain (using NRS at admission) will be measured at PACU, 1h, 2hr. 4hr, 6hr, 8hr, 12hr, 18hr, and 24hrs postoperative. NRS (0 represents "no pain" while 10 represents "the worst pain imaginable").'}, {'measure': 'Time to first request of rescue analgesia.', 'timeFrame': '24 hours postoperatively', 'description': 'Rescue analgesia in the form of IV meperidine (0.5 mg/kg) boluses if NRS \\>3. Time to the 1st rescue analgesic request will be recorded.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Interscalene Block', 'Erector Spinae Plane Block', 'Shoulder Arthroscopy Anesthesia', 'Randomized Controlled Trial']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare the effectiveness of interscalene brachial plexus block alone versus interscalene brachial plexus block +Erector spinae plane block in anesthesia for shoulder arthroscopy.', 'detailedDescription': 'Regional anesthetic techniques can control pain effectively, both at rest and on movement, allowing earlier mobilization without the adverse effects of opioids . Among the various types of regional anesthetic techniques, the interscalene brachial plexus block is a gold standard used nerve block technique for postoperative analgesia in patients undergoing shoulder surgery, as it has consistently been shown to significantly control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18-65 years\n* Both genders,\n* BMI \\< 40 kg/m2\n* American Society of Anesthesiologists (ASA) physical status I-II\n* Scheduled for elective shoulder arthroscopy.\n\nExclusion Criteria:\n\n* Known allergy to local anesthetics,\n* allergy to all opioid medications, diagnostic shoulder arthroscopic procedures,\n* patients with chronic opioids,\n* patients who converted to general anesthesia use and coagulopathy'}, 'identificationModule': {'nctId': 'NCT05646667', 'briefTitle': 'Interscalene Block Alone Versus Interscalene Block With Erector Spinae Plane Block for Shoulder Arthroscopy Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Interscalene Block Alone Versus Interscalene Block With Erector Spinae Plane Block for Shoulder Arthroscopy Anesthesia: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '35915/10/22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interscalene with erector spinae plane block group', 'description': 'Patients will receive interscalene brachial plexus block using 10 ml of bupivacaine 0.5% and ultrasound guided erector spinae plane block at thoracic (T2) using 10 ml of bupivacaine 0.5%.', 'interventionNames': ['Other: interscalene with Erector spinae plane block group']}, {'type': 'EXPERIMENTAL', 'label': 'Interscalene group', 'description': 'Patients will receive interscalene brachial plexus block using 15 ml of bupivacaine 0.5%.', 'interventionNames': ['Other: Interscalene group']}], 'interventions': [{'name': 'interscalene with Erector spinae plane block group', 'type': 'OTHER', 'description': 'patients will receive interscalene brachial plexus block using 10 ml of bupivacaine 0.5% and US guided Erector spinae plane block at T2 using 10 ml of bupivacaine 0.5%.', 'armGroupLabels': ['Interscalene with erector spinae plane block group']}, {'name': 'Interscalene group', 'type': 'OTHER', 'description': 'patients will receive interscalene brachial plexus block using 15 ml of bupivacaine 0.5%.', 'armGroupLabels': ['Interscalene group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tanta', 'country': 'Egypt', 'facility': 'Islam Morsy', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'overallOfficials': [{'name': 'Islam Morsy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tanta University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'from one year after completion of the study.', 'ipdSharing': 'YES', 'description': 'the data will be available upon reasonable request from the principle investigator.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine', 'investigatorFullName': 'Islam Morsy', 'investigatorAffiliation': 'Tanta University'}}}}