Ignite Creation Date:
2025-12-24 @ 9:41 PM
Ignite Modification Date:
2026-03-19 @ 1:34 PM
Study NCT ID:
NCT06790732
Status:
COMPLETED
Last Update Posted:
2025-01-24
First Post:
2025-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative Ultrasound-Guided Peri- Capsular Nerve Group Block on Postoperative Analgesia After Shoulder Arthroscopic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-18', 'studyFirstSubmitDate': '2025-01-18', 'studyFirstSubmitQcDate': '2025-01-18', 'lastUpdatePostDateStruct': {'date': '2025-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to the first request of rescue analgesia', 'timeFrame': '24 hours postoperatively', 'description': 'Time to the first request of rescue analgesia was recorded from the end of the surgery till first dose of morphine administrated.'}], 'secondaryOutcomes': [{'measure': 'Degree of pain', 'timeFrame': '24 hours postoperatively', 'description': 'The degree of pain was assessed using the Numerical Rating Scale (NRS) Pain score (metric score from 0 to 10 where 0 = no pain and 10 = maximal pain). NRS was recorded at PACU and 2, 4, 6, 8, 12, 16, 20, and 24 h postoperative.'}, {'measure': 'Total morphine consumption', 'timeFrame': '24 hours postoperatively', 'description': 'If patient numeric rating score was more than 3, patients received 3 mg morphine slowly intravenously. Morphine injection was repeated whenever required.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Preoperative', 'Ultrasound-Guided', 'PeriCapsular Nerve Group Block', 'Postoperative Analgesia', 'Shoulder Arthroscopic Surgery']}, 'descriptionModule': {'briefSummary': 'This study aimed to evaluate the analgesic efficacy of preoperative ultrasound-guided peri-capsular nerve group block (PENG) on postoperative analgesia after shoulder arthroscopic surgery.', 'detailedDescription': 'Postoperative pain control after shoulder surgery is challenging, and poor pain management is invariably reflected in poor outcomes, with longer hospitalization and recovery time. The difficulty in reducing pain due to the complexity of shoulder innervation leads to conducting studies to explore selective axillary nerve blocks with a posterior approach or from the axillae.\n\nThe peri-capsular nerve group (PENG) block is a regional anesthetic technique. It can be effectively and safely applied under ultrasound guidance in shoulder surgery cases for postoperative analgesia. It targets only the sensory branches and not the posterior mechanoreceptors; there is a potential motor-sparing effect which is desirable for better physical therapy, and earlier discharge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age from 21 to 65 years.\n* Both sexes.\n* American Society of Anesthesiologists (ASA) physical status I-III.\n* Scheduled for unilateral shoulder arthroscopic surgery.\n\nExclusion Criteria:\n\n* Patient refusal.\n* Known hypersensitivity to local anesthetics.\n* Body mass index\\> 35 kg /m2.\n* Uncooperative or psychiatric patients.\n* Infection at the injection site.\n* Coagulation disorder.\n* Major cardiac, renal, or hepatic diseases.'}, 'identificationModule': {'nctId': 'NCT06790732', 'briefTitle': 'Preoperative Ultrasound-Guided Peri- Capsular Nerve Group Block on Postoperative Analgesia After Shoulder Arthroscopic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'The Effect of Preoperative Ultrasound-Guided Peri- Capsular Nerve Group Block on Postoperative Analgesia After Shoulder Arthroscopic Surgery', 'orgStudyIdInfo': {'id': '36264MS117/3/23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Control Group', 'description': 'Patients received sham PENG block (just 1mL saline).', 'interventionNames': ['Drug: Saline']}, {'type': 'EXPERIMENTAL', 'label': 'PeriCapsular Nerve Group Block (PENG) Group', 'description': 'Patients received real PENG block (15 mL of bupivacaine 0.25% +0.2mg/mL dexamethasone).', 'interventionNames': ['Drug: Bupivacaine + Dexamethasone']}], 'interventions': [{'name': 'Saline', 'type': 'DRUG', 'description': 'Patients received sham PENG block (just 1mL saline).', 'armGroupLabels': ['Control Group']}, {'name': 'Bupivacaine + Dexamethasone', 'type': 'DRUG', 'otherNames': ['PeriCapsular Nerve Group Block (PENG)'], 'description': 'Patients received real PENG block (15 mL of bupivacaine 0.25% +0.2mg/mL dexamethasone).', 'armGroupLabels': ['PeriCapsular Nerve Group Block (PENG) Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31527', 'city': 'Tanta', 'state': 'El-Gharbia', 'country': 'Egypt', 'facility': 'Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After the end of study for one year.', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of study for one year.', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.', 'investigatorFullName': 'Kareem Ayman Khattab', 'investigatorAffiliation': 'Tanta University'}}}}