Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2026-01-06 @ 10:55 AM
Study NCT ID:
NCT06999460
Status:
RECRUITING
Last Update Posted:
2025-06-12
First Post:
2025-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analgesic Effect of Infraspinatus-teres Minor Block for Pre-emptive Analgesia in Patients Undergoing Shoulder Surgeries.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Anesthetist not sharing in the study will assess outcomes'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'To study the efficacy of the infraspinatus-teres minor (ITM) block as pre-emptive analgesia in pain management in patients undergoing shoulder surgeries.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-09', 'studyFirstSubmitDate': '2025-05-19', 'studyFirstSubmitQcDate': '2025-05-22', 'lastUpdatePostDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'total amount of rescue analgesic consumption', 'timeFrame': 'for 24 hours', 'description': 'To assess the total amount of rescue analgesic consumption in the first 24 hours post-operatively in each group.'}, {'measure': 'total amount of intraoperative supplementary fentanyl consumption.', 'timeFrame': 'up to 3 hours', 'description': 'To measure total amount of intraoperative supplementary fentanyl consumption.'}], 'secondaryOutcomes': [{'measure': 'Numerical Rate Scale (NRS) at rest (static) and during passive or active movement of shoulder (dynamic).', 'timeFrame': '30 minutes after arrival in the post-anesthesia care unit (PACU), 2 hours, 4 hours, 8 hours, 12 hours, and 24 hours postoperatively.', 'description': 'To assess pain score by using numerical rate scale (NRS) at rest (static) and during passive or active movement of shoulder (dynamic). NRS scale will be explained to all patients as follows: 0= no pain and 10= worst pain.'}, {'measure': 'Time to the first request of rescue analgesia postoperatively', 'timeFrame': '24 hours postoperative', 'description': 'To assess the time to the first request of rescue analgesia (morphine) postoperatively'}, {'measure': 'Discharge time from post anesthesia care unit (PACU)', 'timeFrame': '24 hours', 'description': 'the time from admission to the post-anesthesia care unit (PACU) till discharge from the PACU when the Aldrete score is ≥9).'}, {'measure': 'To assess side effects of systemic opioids', 'timeFrame': 'for 24 hours', 'description': 'To assess side effects of systemic opioids (constipation, itching, dizziness, nausea \\& vomiting'}, {'measure': 'the incidence of block -related side effects or complications', 'timeFrame': 'for 24 hours', 'description': 'To assess the incidence of block -related side effects or complications (hematoma, infection or LA toxicity).'}, {'measure': "patient's satisfaction", 'timeFrame': 'for 24 hours', 'description': 'The patients will be asked to rate the overall degree of satisfaction of the analgesia by using a 5-points Likert-like verbal scale (1 = very dissatisfied analgesia, 2 = dissatisfied analgesia, and 3 = neutral, 4=satisfied analgesia, and 5=very satisfied analgesia)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['infraspinatus teres minor block', 'preemptive analgesia', 'shoulder surgery'], 'conditions': ['Preemptive Analgesia']}, 'descriptionModule': {'briefSummary': 'The aim of the study to evaluate the efficacy of the infraspinatus-teres minor (ITM) block in improving pre-emptive analgesia, reducing opioid consumption, and enhancing the overall analgesic effect in patients undergoing shoulder surgeries.', 'detailedDescription': "To compare between infraspinatus-teres minor versus control group (GA):\n\n1. To measure analgesic parameters including: the total amount of rescue analgesic consumption (morphine) in the first 24 hours post-operatively in each group, duration of analgesia, and total amount of intraoperative fentanyl consumption and\n2. To assess pain score by using numerical rate scale (NRS) at rest (static) and during passive or active movement of shoulder joint (dynamic).\n3. To assess discharge time from post anesthesia care unit (PACU).\n4. To assess side effects of systemic opioids (constipation, itching, dizziness, nausea and vomiting) and complications of infraspinatus-tere minor block.\n5. Patients' satisfaction: The patients will be asked to rate the overall degree of satisfaction of the analgesia by using a 5-points Likert-like verbal scale (1 = very dissatisfied analgesia, 2 = dissatisfied analgesia, and 3 = neutral, 4=satisfied analgesia, and 5=very satisfied analgesia)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* • Patients' acceptance.\n\n * Age: Adults aged 21-65 years old.\n * BMI: 25-30 kg/m2\n * Sex: both sexes (males or females).\n * Patients undergoing unilateral shoulder surgey under general anesthesia.\n * ASA (American Society of Anesthesiologists) physical status classification I to II.\n * Duration of the surgery \\< 3hours.\n\nExclusion Criteria:\n\n* • Patients with contraindications to regional anesthesia (e.g. local or systemic infections, or severe neurological or muscular or bleeding disorders or patient on anticoagulant).\n\n * Allergy to study medications: bupivacaine or dexamethasone, or dexmedetomidine\n * Patients with severe cardiovascular, respiratory, renal, or hepatic diseases, uncontrolled diabetes , or those undergoing chronic opioid therapy.\n * Psychiatric disorders that hinder informed consent or study participation.\n * history of neurological diseases or conditions that would affect the efficacy of nerve blocks (e.g., neuropathy, spinal cord injury, or history of severe muscle weakness).\n * Patients with nerve injury or disease around the shoulder joint, including thoracic outlet syndrome, Multiple sclerosis, cervical disc disease with ipsilateral radiculopathy, or patients with abnormal sensory or motor function of the upper limb."}, 'identificationModule': {'nctId': 'NCT06999460', 'briefTitle': 'Analgesic Effect of Infraspinatus-teres Minor Block for Pre-emptive Analgesia in Patients Undergoing Shoulder Surgeries.', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Zagazig University'}, 'officialTitle': 'A Novel Approach to Shoulder Analgesia: Infraspinatus-teres Minor Block for Pre-emptive Analgesia in Patients Undergoing Shoulder Surgeries: A Randomized Controlled Study', 'orgStudyIdInfo': {'id': '1299'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '*Group Infraspinatus teres minor block (ITM group)', 'description': 'Patients in this group will receive a unilateral ultrasound-guided Infraspinatus-teres minor (ITM) block with injection of local anesthetics (20 mL of bupivacaine 0.25% (50 mg), 50 mcg dexmedetomidine (0.5 ml) and 8 mg dexamethasone (2 ml)) before induction of general anesthesia', 'interventionNames': ['Procedure: Infraspinatus teres minor block group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group (group C)', 'description': 'Patients in this group will receive general anesthesia.', 'interventionNames': ['Procedure: Control group']}], 'interventions': [{'name': 'Infraspinatus teres minor block group', 'type': 'PROCEDURE', 'description': 'Patients in this group will receive a unilateral ultrasound-guided Infraspinatus-teres minor (ITM) block with injection of local anesthetics (20 mL of bupivacaine 0.25% (50 mg), 50 mcg dexmedetomidine (0.5 ml) and 8 mg dexamethasone (2 ml)) before induction of general anesthesia', 'armGroupLabels': ['*Group Infraspinatus teres minor block (ITM group)']}, {'name': 'Control group', 'type': 'PROCEDURE', 'description': 'Patients in this group will receive general anesthesia', 'armGroupLabels': ['Control group (group C)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zagazig', 'state': 'Egypt', 'status': 'RECRUITING', 'country': 'Egypt', 'facility': 'Faculity of medicine, Zagazig university, Zagazig', 'geoPoint': {'lat': 30.58768, 'lon': 31.502}}, {'city': 'Zagazig', 'status': 'RECRUITING', 'country': 'Egypt', 'facility': 'Faculty of human medicine, Zagazig university, Zagazig', 'geoPoint': {'lat': 30.58768, 'lon': 31.502}}], 'centralContacts': [{'name': 'Dina Elsadek Salem, MD', 'role': 'CONTACT', 'email': 'dinamaghraby@yahoo.com', 'phone': '01099333513', 'phoneExt': '002'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zagazig University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principle investigator', 'investigatorFullName': 'Dina Abdelhameed Elsadek Salem', 'investigatorAffiliation': 'Zagazig University'}}}}