Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 10:32 PM
Study NCT ID:
NCT05788367
Status:
UNKNOWN
Last Update Posted:
2023-10-03
First Post:
2023-01-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pericapsular Nerve Block Versus Interscalene Nerve Block for Acute Pain Management in Shoulder Arthroscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-01', 'studyFirstSubmitDate': '2023-01-12', 'studyFirstSubmitQcDate': '2023-03-25', 'lastUpdatePostDateStruct': {'date': '2023-10-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Asses The postoperative opioid consumption', 'timeFrame': '24 hours postoperatively', 'description': 'the postoperative opioid consumption during the procedure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pericapsular Nerve Block', 'Interscalene Nerve Block', 'Shoulder Arthroscopy']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare PENG and ISB after shoulder arthroscopy for postoperative pain management after shoulder arthroscopy.', 'detailedDescription': 'Shoulder arthroscopy is a common procedure done is orthopedics for many surgical indications as rotator cuff tears, stiffness and instability. This procedure has a well - documented postoperative pain. To improve the outcome after surgery, effective pain control is needed.\n\nVarious methods are used for postoperative pain management. Intravenous opioid agents are among them, but they may cause undesirable side effects, such as respiratory depression, sedation, constipation, allergic reaction, nausea, and vomiting. Thus, alternative techniques are preferred.\n\nInterscalene brachial plexus blocks (ISBPBs) are often used to provide perioperative analgesia and anesthesia for shoulder surgery. They target nerve roots C4-C6 and thereby provide regional analgesia to the shoulder and upper arm. Although ISBPBs are often performed in combination with general anesthesia (GA) to enhance postoperative analgesia, they are also sometimes used as a sole means of anesthesia.\n\nThe pericapsular nerve group (PENG) block is an ultrasound-guided approach, first described by Giron-Arango et al. for the blockade of the articular branches of the femoral, obturator and accessory obturator nerves that provide sensory innervation to the anterior hip capsule. It has been successfully used as an alternative regional anaesthesia technique for the management of acute pain after hip fracture, and for analgesia after elective hip surgery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index \\< 40 kg/m2\n* American Society of Anesthesiologists (ASA) physical status I-II\n* posted for elective shoulder arthroscopy\n\nExclusion Criteria:\n\n* Known allergy to local anesthetics\n* allergy to all opioid medications\n* diagnostic shoulder arthroscopic procedures\n* patients with chronic opioids use and coagulopathy'}, 'identificationModule': {'nctId': 'NCT05788367', 'briefTitle': 'Pericapsular Nerve Block Versus Interscalene Nerve Block for Acute Pain Management in Shoulder Arthroscopy', 'organization': {'class': 'OTHER', 'fullName': 'Kafrelsheikh University'}, 'officialTitle': 'Pericapsular Nerve Block Versus Interscalene Nerve Block for Acute Pain Management in Shoulder Arthroscopy: A Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'MKSU 50-12-7'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'The pericapsular nerve group', 'description': 'patients received Ultrasound guided The pericapsular nerve group block using 20 ml of bupivacaine 0.5%', 'interventionNames': ['Procedure: The pericapsular nerve group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Interscalene group', 'description': 'patients will receive interscalene brachial plexus block using 15 ml of bupivacaine 0.5% before induction of general anesthesia.', 'interventionNames': ['Procedure: Interscalene brachial plexus block']}], 'interventions': [{'name': 'The pericapsular nerve group', 'type': 'PROCEDURE', 'description': 'patients received Ultrasound guided pericapsular nerve group block using 20 ml of bupivacaine 0.5%', 'armGroupLabels': ['The pericapsular nerve group']}, {'name': 'Interscalene brachial plexus block', 'type': 'PROCEDURE', 'description': 'patients will receive interscalene brachial plexus block using 15 ml of bupivacaine 0.5% before induction of general anesthesia', 'armGroupLabels': ['Interscalene group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33516', 'city': 'Kafr ash Shaykh', 'state': 'Kafrelsheikh', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mohammed F Algyar, MD', 'role': 'CONTACT', 'email': 'mohammad.algaiar@med.kfs.edu.eg', 'phone': '00201111645345', 'phoneExt': '047'}], 'facility': 'Mohammed Fouad Mohamed Algyar', 'geoPoint': {'lat': 31.11174, 'lon': 30.93991}}], 'centralContacts': [{'name': 'Mohammed F Algyar, MD', 'role': 'CONTACT', 'email': 'mohammad.algaiar@med.kfs.edu.eg', 'phone': '00201111645345', 'phoneExt': '047'}], 'overallOfficials': [{'name': 'Mohammed F Algyar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lecturer of Anaesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Kafrelsheikh University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'One year after the end of the study', 'ipdSharing': 'YES', 'description': 'The data will be provided under a reasonable request from the corresponding author'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kafrelsheikh University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Anaesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Kafrelsheikh University', 'investigatorFullName': 'Mohamed Fouad Algyar', 'investigatorAffiliation': 'Kafrelsheikh University'}}}}