Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-29 @ 11:30 PM
Study NCT ID:
NCT07429669
Status:
RECRUITING
Last Update Posted:
2026-02-24
First Post:
2026-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Analgesia and Respiratory Effects of Shoulder Blocks
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D059787', 'term': 'Acute Pain'}], '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': 'D003766', 'term': 'Dental Occlusion'}], 'ancestors': [{'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D009063', 'term': 'Dental Physiological Phenomena'}, {'id': 'D055688', 'term': 'Digestive System and Oral Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-23', 'studyFirstSubmitDate': '2026-02-13', 'studyFirstSubmitQcDate': '2026-02-23', 'lastUpdatePostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain scores', 'timeFrame': 'First hour after the surgery', 'description': 'Pain will be assessed at rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 100 (worst pain) at the first postoperative hour.'}], 'secondaryOutcomes': [{'measure': 'Pain scores', 'timeFrame': 'First 24 hours after surgery', 'description': 'Pain will be assessed at rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 100 (worst pain). Pain assessment will be done at the 1st, 2nd, 6th, 12th, and 24th hours after surgery.'}, {'measure': 'Forced vital capacity (FVC) (volume)', 'timeFrame': 'Perioperative period', 'description': 'Forced vital capacity (FVC) (volume) will be evaluated during the perioperative period. Measurements will be performed before block administration (baseline), at 30 minutes after the block, and at postoperative 1, 12, and 24 hours.'}, {'measure': 'Forced expiratory flow in 1 s (FEV1) (volume)', 'timeFrame': 'Perioperative period', 'description': 'Forced expiratory flow in 1 s (FEV1) (volume) will be evaluated during the perioperative period. Measurements will be performed before block administration (baseline), at 30 minutes after the block, and at postoperative 1, 12, and 24 hours.'}, {'measure': 'FEV1/FVC', 'timeFrame': 'Perioperative period', 'description': 'FEV1/FVC will be evaluated during the perioperative period. Measurements will be performed before block administration (baseline), at 30 minutes after the block, and at postoperative 1, 12, and 24 hours.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Interscalene block', 'Anterior suprascapular block', 'Pericapsular nerve group block', 'Shoulder Block', 'Arthroscopic shoulder surgery', 'Pain, acute', 'Pain, Postoperative'], 'conditions': ['Postoperative Pain', 'Arthroscopic Shoulder Surgery']}, 'descriptionModule': {'briefSummary': 'Interscalene block is widely accepted as the gold-standard regional analgesic technique for pain control after arthroscopic shoulder surgery. However, because this block is performed at the level of the brachial plexus roots, it may be associated with adverse effects such as phrenic nerve blockade and subsequent diaphragmatic dysfunction. These limitations have prompted the search for alternative regional anesthesia techniques that can provide effective postoperative analgesia while preserving respiratory function.\n\nThe anterior suprascapular block, which covers a broad dermatomal distribution of the shoulder region, has been shown in some studies to provide sufficient analgesia as a standalone technique. In addition, the pericapsular nerve group (PENG) block of the shoulder-applied around the anterior capsule and performed at a distance from critical neurovascular structures that may lead to serious complications-may represent another potential analgesic option following arthroscopic shoulder procedures.\n\nTherefore, this study aims to evaluate alternative regional block techniques in comparison with the interscalene block and to contribute to the identification of an optimal analgesic strategy after arthroscopic shoulder surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with ASA scores I-II-III\n* Patients scheduled for elective arthroscopic shoulder surgery\n* Patients who have been informed about the study and have given written consent will be included.\n\nExclusion Criteria:\n\n* Those with a known allergy to local anesthetics\n* Those with an infection at the application site\n* Those with a severe coagulopathy disorder or anticoagulant use\n* Those with contralateral phrenic nerve palsy or a serious pulmonary diagnosis\n* Those with a history of chronic opioid use or neuropathic pain'}, 'identificationModule': {'nctId': 'NCT07429669', 'briefTitle': 'Comparative Analgesia and Respiratory Effects of Shoulder Blocks', 'organization': {'class': 'OTHER', 'fullName': 'Atatürk Chest Diseases and Chest Surgery Training and Research Hospital'}, 'officialTitle': 'Analgesic Efficacy and Respiratory Effects of Interscalene, Anterior Suprascapular, and Pericapsular Nerve Group Blocks in Shoulder Arthroscopy', 'orgStudyIdInfo': {'id': 'AEŞH-EK-2026-020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Interscalene block', 'description': 'In the preoperative period, 10 mL of 0.25% bupivacaine will be injected between C5 and C6 using an in-plane technique guided by a linear ultrasound (US) probe.', 'interventionNames': ['Procedure: Interscalene block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Anterior suprascapular block', 'description': 'A linear ultrasound probe will be positioned in the supraclavicular fossa, parallel to the clavicle. The suprascapular nerve will be identified as a hyperechoic oval structure deep to the omohyoid muscle and posterior-lateral to the brachial plexus. 10 mL of local anesthetic will be injected under the omohyoid muscle, around the suprascapular nerve.', 'interventionNames': ['Procedure: Anterior suprascapular block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pericapsular nerve group (PENG) block', 'description': 'A linear ultrasound probe will be placed sagittally, near the axillary region, just below the coracoid process. The subscapularis muscle and its tendon will be visualized. The target area is the space between the deep fascia of the subscapularis muscle and the anterior surface of the shoulder joint capsule. The needle will pass the subscapularis muscle and be guided into the plane between the capsule and the muscle, where 20 mL of local anesthetic will be dispensed to block the articular branches innervating the capsule.', 'interventionNames': ['Procedure: Pericapsular nerve group (PENG) block']}], 'interventions': [{'name': 'Interscalene block', 'type': 'PROCEDURE', 'description': 'Interscalene block will be performed, under US guidance, before the surgical operation, and when the patient is placed in the supine position.', 'armGroupLabels': ['Interscalene block']}, {'name': 'Anterior suprascapular block', 'type': 'PROCEDURE', 'description': 'Anterior suprascapular block will be performed, under US guidance, before the surgical operation, and when the patient is placed in the supine position.', 'armGroupLabels': ['Anterior suprascapular block']}, {'name': 'Pericapsular nerve group (PENG) block', 'type': 'PROCEDURE', 'description': 'Pericapsular nerve group (PENG) block will be performed, under US guidance, before the surgical operation, and when the patient is placed in the supine position.', 'armGroupLabels': ['Pericapsular nerve group (PENG) block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06170', 'city': 'Yenimahalle', 'state': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Musa Zengin, Associate Professor', 'role': 'CONTACT', 'email': 'musazengin@gmail.com', 'phone': '00905307716235'}, {'name': 'Muammer Bulut, MD', 'role': 'CONTACT', 'email': 'muammerblt8@gmail.com', 'phone': '00905545839533'}], 'facility': 'Ankara Etlik City Hospital', 'geoPoint': {'lat': 39.97787, 'lon': 32.80147}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Atatürk Chest Diseases and Chest Surgery Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal İnvestigator', 'investigatorFullName': 'Musa Zengin', 'investigatorAffiliation': 'Ankara Etlik City Hospital'}}}}