Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2026-01-09 @ 9:53 PM
Study NCT ID:
NCT06529393
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-24
First Post:
2024-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Analgesic Effect of (SHAC) Block Versus Suprascapular Nerve Block in Arthroscopic Shoulder Surgeries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020069', 'term': 'Shoulder Pain'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D018771', 'term': 'Arthralgia'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, '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': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'For the SHAC block, with the patient in a beach-chair position and with the arm in extension,With external rotation and abduction,A 21G 10-cm needle will be inserted using an in-plane approach .The tip of the needle will be placed at the space where the nerve has passed .A volume of 15 mL of a mixture of 2% lidocaine (5 mL) and 0.5% levobupivacaine (10 mL) was injected By injecting the pericapsular space, we reach the terminal articular branches indistinctly from their origin.\n\nFor suprascapular nerve block :\n\nPatients will be placed in lateral position until supraspinatus or infraspinatus muscle contractions were elicited. Following negative aspiration,A 21G 10-cm needle will be inserted using an in-plane approach .The tip of the needle will be placed at the floor of the supraspinatus fossa where the nerve has passed .A volume of 15 mL of a mixture of 2% lidocaine (5 mL) and 0.5% levobupivacaine (10 mL) was injected.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-21', 'studyFirstSubmitDate': '2024-07-15', 'studyFirstSubmitQcDate': '2024-07-26', 'lastUpdatePostDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'effect on postopeartive pain after shoulder arthrscopy', 'timeFrame': 'baseline', 'description': 'the pain intensity assessment at rest and on coughing using Numerical Rating Scale (NRS) This will measure pain intensity from 0 to 10 , 0: no pain 3:mild pain 7:moderate pain 10:severe pain'}], 'secondaryOutcomes': [{'measure': '-inceidence of (POVN) 24 hours postoperatively -Block related complications during and after block procedure till 24 hours postoperatively (LAST, pneumohorax and vascular puncture during block procedure)', 'timeFrame': 'first 24 hours', 'description': 'patients complaint from occurrence of nausea and vomiting'}, {'measure': '-Time of the first opioid request', 'timeFrame': 'first 24 hour', 'description': 'time of the first opioid request , concentration and occurrence of complications (hypotension,bradycardia,itching,urinary retention.) all over 24 hours postoperatively'}, {'measure': '-Block related complications during and after block procedure till 24 hours postoperatively (LAST, pneumohorax and vascular puncture during block procedure)', 'timeFrame': 'first 24 hours', 'description': 'occurrence of any complications from technical errors'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SHAC Block'], 'conditions': ['Shoulder Pain', 'Postoperative Pain']}, 'referencesModule': {'references': [{'pmid': '20565394', 'type': 'BACKGROUND', 'citation': 'Fredrickson MJ, Krishnan S, Chen CY. Postoperative analgesia for shoulder surgery: a critical appraisal and review of current techniques. Anaesthesia. 2010 Jun;65(6):608-624. doi: 10.1111/j.1365-2044.2009.06231.x.'}, {'pmid': '23728958', 'type': 'BACKGROUND', 'citation': 'Paxton ES, Backus J, Keener J, Brophy RH. Shoulder arthroscopy: basic principles of positioning, anesthesia, and portal anatomy. J Am Acad Orthop Surg. 2013 Jun;21(6):332-42. doi: 10.5435/JAAOS-21-06-332.'}, {'pmid': '15271745', 'type': 'BACKGROUND', 'citation': 'Singelyn FJ, Lhotel L, Fabre B. Pain relief after arthroscopic shoulder surgery: a comparison of intraarticular analgesia, suprascapular nerve block, and interscalene brachial plexus block. Anesth Analg. 2004 Aug;99(2):589-92, table of contents. doi: 10.1213/01.ANE.0000125112.83117.49.'}, {'pmid': '27904211', 'type': 'BACKGROUND', 'citation': 'Basat HC, Ucar DH, Armangil M, Guclu B, Demirtas M. Post operative pain management in shoulder surgery: Suprascapular and axillary nerve block by arthroscope assisted catheter placement. Indian J Orthop. 2016 Nov-Dec;50(6):584-589. doi: 10.4103/0019-5413.193474.'}, {'pmid': '8586108', 'type': 'BACKGROUND', 'citation': 'Brenner W, Bohuslavizki KH, Wolf H, Sippel C, Clausen M, Henze E. Radiotherapy with iodine-131 in recurrent malignant struma ovarii. Eur J Nucl Med. 1996 Jan;23(1):91-4. doi: 10.1007/BF01736995.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to compare the post-operative analgesic effect of Shoulder anterior capsule (SHAC) block with Suprascapular nerve block for arthroscopic shoulder surgery with a hypothesis that both Shoulder anterior capsule (SHAC) block and Suprascapular nerve block are effective in providing postoperative analgesia for arthroscopic shoulder surgery.', 'detailedDescription': 'The role of shoulder arthroscopy in the diagnosis and treatment of shoulder disorders is evolving .\n\nAdvances in modern arthroscopy have contributed significantly to greater flexibility and efficacy in addressing shoulder pathology.Advantages of arthroscopy include less invasive approaches, improved visualization, decreased risk of many postoperative complications ,and faster recovery.\n\nShoulder surgery is well recognised as having the potential to cause severe postoperative pain.The aim of this review is to assess critically the evidence relating to the effectiveness of regional anaesthesia techniques commonly used for postoperative analgesia following shoulder surgery opioid analgesics are commonly used for analgesia when nerve block are not used. opoids are effective in relieving postoperative pain at rest but may increase postoperative nausea and vomiting (PONV),somnolence,constipation,urinary retention,respiratory depression ,and sleep disturbances.\n\nsupplementing general anesthesia (GA) with a regional nerve block might improve the quality of postoperative relief pain .\n\nThroughout intraoperative and postoperative period, nerve blocks have been used more populary than others because of efficacy.For the regional nerve block,local anesthetic should be infiltrated close to the nerve for maximum effect.\n\nShoulder anterior capsule block (SHAC):is combination of two different blocks .the first block is the interfascial space between the deep layer of the deltoid fascia and the superficial layer of the subscapularis fascia , anterior to the subscapularis myotendinous junction . Thanks to this interfascial space,we can reach both the axillary nerve and the subscapular nerves,the lateral pectoral nerve and the musculocutaneous nerve.\n\nSuprascapular nerve block(SSB) :The suprascabular nerve (SSN) originates from the nerve roots and provides sensation for the posterior shoulder capsule, acromioclavicular joint,subacromial bursa,and coracoclavicular ligament .Blocking it provides pre-emptive anesthesia , decreased intraoperative pain ,and postoperative pain relief in shoulder arthroscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* -Age between 18-65 years.\n* Body mass index (BMI)of 18-35Kg /m2.\n* Patients with American society of anesthesiologist (ASA) physical status \\| / \\|\\|.\n* Patients scheduled for elective Arthroscopic Shoulder Surgery.\n* Both sexes, males and females.\n\nExclusion Criteria:\n\n* -Patient refusal.\n* Allergy to local anaesthetics.\n* Infection at the site of injection .\n* Coagulopathy.\n* Chronin pain syndromes.\n* Prolonged opioid medication\n\n .-Patients who received any analgesia 24 h before surgery.\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT06529393', 'briefTitle': 'The Analgesic Effect of (SHAC) Block Versus Suprascapular Nerve Block in Arthroscopic Shoulder Surgeries', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'The Analgesic Effect of Shoulder Anterior Capsule (SHAC) Block Versus Suprascapular Nerve Block in Arthroscopic Shoulder Surgeries', 'orgStudyIdInfo': {'id': 'SHAC Block'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'SHAC block group', 'description': 'For the SHAC block, with the patient in a beach-chair position and with the arm in extension, the subscapularis muscle is stretched posteriorly and becomes easily visible. With external rotation and abduction, the coracobrachialis and the biceps brachii muscles are displaced, allowing the visualization of the interfascial space between the deep lamina of the deltoid muscle fascia and the superficial lamina of the subscapularis fascia.Once the injection into the fascial space is achieved, the investigators can proceed towards the glenohumeral pericapsular space by crossing the subscapularis muscle with the needle. By injecting the pericapsular space, the investigators reach the terminal articular branches indistinctly from their origin. Furthermore, through the Weitbrecht foramen, a natural capsular foramen between the upper and middle glenohumeral ligaments, we also reach the intra-articular space .', 'interventionNames': ['Procedure: SHAC block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Suprascapular nerve block group', 'description': 'Patients will be placed in lateral position by using A high - frequency linear ultrasound probe will be placed approximately 2 cm medial to the medial border of the acromion and about 2 cm cranial to the superior margin of the scapular spine until supraspinatus or infraspinatus muscle contractions were elicited. Following negative aspiration,A 21G 10-cm needle will be inserted using an in-plane approach .The tip of the needle will be placed at the floor of the supraspinatus fossa where the nerve has passed .A volume of 15 mL of a mixture of 2% lidocaine (5 mL) and 0.5% levobupivacaine (10 mL) was injected.', 'interventionNames': ['Procedure: suprascapular nerve block']}], 'interventions': [{'name': 'SHAC block', 'type': 'PROCEDURE', 'otherNames': ['shoulder anterior capsule block'], 'description': 'with the patient in a beach-chair position and with the arm in extension, the subscapularis muscle is stretched posteriorly and becomes easily visible. With external rotation and abduction, the coracobrachialis and the biceps brachii muscles are displaced, allowing the visualization of the interfascial space between the deep lamina of the deltoid muscle fascia and the superficial lamina of the subscapularis fascia.Once the injection into the fascial space is achieved, the investigators can proceed towards the glenohumeral pericapsular space by crossing the subscapularis muscle with the needle. By injecting the pericapsular space, the investigators reach the terminal articular branches indistinctly from their origin. Furthermore, through the Weitbrecht foramen, a natural capsular foramen between the upper and middle glenohumeral ligaments, the investigators also reach the intra-articular space .', 'armGroupLabels': ['SHAC block group']}, {'name': 'suprascapular nerve block', 'type': 'PROCEDURE', 'description': 'Patients will be placed in lateral position by using A high - frequency linear ultrasound probe will be placed approximately 2 cm medial to the medial border of the acromion and about 2 cm cranial to the superior margin of the scapular spine until supraspinatus or infraspinatus muscle contractions were elicited. Following negative aspiration,A 21G 10-cm needle will be inserted using an in-plane approach .The tip of the needle will be placed at the floor of the supraspinatus fossa where the nerve has passed .A volume of 15 mL of a mixture of 2% lidocaine (5 mL) and 0.5% levobupivacaine (10 mL) was injected.', 'armGroupLabels': ['Suprascapular nerve block group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'facility': 'New Trauma Hospital', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Rana EA Ibrahim, Resident', 'role': 'CONTACT', 'email': 'relsayed324@gmail.com', 'phone': '00201069626195'}, {'name': 'Ayman M Abdel Khalek, Ass professor', 'role': 'CONTACT', 'email': 'Aymanglala@aun.edu.eg', 'phone': '00201025675901'}], 'overallOfficials': [{'name': 'Mohamed S Hassanen, professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Assuit university Hospital'}, {'name': 'Rana EA Ibrahim, Resident', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assuit university Hospital'}, {'name': 'Ayman Abdel Khalek, Ass professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assuit university Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'method outcome'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'doctor', 'investigatorFullName': 'Rana El-sayed Ali Ibrahim', 'investigatorAffiliation': 'Assiut University'}}}}