Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 10:58 PM
Study NCT ID:
NCT06869967
Status:
RECRUITING
Last Update Posted:
2025-11-21
First Post:
2025-03-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Postoperative Pain Control in Ear Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D000377', 'term': 'Agnosia'}], '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'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, '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': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 56}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-02-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-20', 'studyFirstSubmitDate': '2025-03-05', 'studyFirstSubmitQcDate': '2025-03-05', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Opioid consumption', 'timeFrame': 'During the operation', 'description': 'Intraoperative opioid consumption'}], 'secondaryOutcomes': [{'measure': 'Morphine consumption', 'timeFrame': '1 hours after surgery(T1), 6 hours after surgery (T2), 12 hours after surgery (T3), 24 hours after surgery (T4)', 'description': 'Postoperative morphine consumption'}, {'measure': 'NRS Scores', 'timeFrame': '1 hours after surgery(T1), 6 hours after surgery (T2), 12 hours after surgery (T3), 24 hours after surgery (T4)', 'description': 'NRS scores of the patients after the surgery (0=no pain, 10=worst pain imaginable)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Regional Anesthesia', 'Ear Surgery', 'Auricularis Magnus Nerve Block'], 'conditions': ['Post Operative Pain', 'Analgesia']}, 'descriptionModule': {'briefSummary': 'Middle ear surgery is the most popular procedure in ear, nose and throat surgery. Increased sympathetic stimulation after surgery can activate the sympathetic system, causing hypertension and increased heart rate. As a result of these clinical conditions, hemorrhage can occur, which can impair the quality of the surgical field, which is undesirable in middle ear surgery.Clinical studies should be conducted with auricularis magnus nerve block applied in the perioperative period in middle ear surgery and postoperative pain scores.', 'detailedDescription': 'Middle ear surgery is the most popular procedure in ear, nose and throat surgery. Increased sympathetic stimulation after surgery can activate the sympathetic system, causing hypertension and increased heart rate. As a result of these clinical conditions, hemorrhage can occur, which can impair the quality of the surgical field, which is undesirable in middle ear surgery.Ultrasound-guided auricularis magnus nerve block can be used as a potential solution to these problems. Ultrasound-guided peripheral nerve block can be visualized. It is appropriate and applicable to block a single distal nerve with a small dose of local anesthetic under ultrasound guidance. Ultrasound-guided blocking of the blocked area has reduced side effects with increased accuracy and accurate analgesic effect.\n\nIn middle ear microsurgery, the nerve innervation of the postauricular incision area may not primarily originate from the auricularis magnus. Therefore, clinical studies should be conducted with auricularis magnus nerve block applied in the perioperative period in middle ear surgery and postoperative pain scores.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients undergoing CWD and Mastodectom\n* Patients undergoing elective surgery\n* ASA (American Society of Anesthesiologists) physical status classification I-II\n* Patients over 18 years of age\n\nExclusion Criteria:\n\n* Anticoagulant use\n* Allergy to the drugs to be used\n* ASA (American Society of Anesthesiologists) physical status classification IV-V\n* Presence of infection in the area where the block will be applied\n* Patient's refusal to accept the block application or inability to cooperate with the patient"}, 'identificationModule': {'nctId': 'NCT06869967', 'briefTitle': 'Evaluation of Postoperative Pain Control in Ear Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Kocaeli University'}, 'officialTitle': 'Evaluation of Ultrasound-Guided Auricularis Magnus Nerve Block for Postoperative Pain Control in Ear Surgery', 'orgStudyIdInfo': {'id': '2024-KAEK-11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Auricularis Magnus Nerve Block', 'description': 'Ultrasound (US) -guided Auricularis Magnus Nerve Block with 5 ml 0.5 % bupivacaine will performe preoperatively to all patients in the AMG group.', 'interventionNames': ['Procedure: Auricularis Magnus Nerve Block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'In the control group, patients will be administered intravenous analgesics of 1 gram paracetamol, 20 mg tenoxicam, and 8 mg ondansetron 30 minutes before the end of the operation, as stated in the patient protocol, during their follow-up after general anesthesia.', 'interventionNames': ['Procedure: Control Group']}], 'interventions': [{'name': 'Auricularis Magnus Nerve Block', 'type': 'PROCEDURE', 'description': 'Auricularis Magnus Nerve block will be performed using 5 mL of %0.5 bupivacaine', 'armGroupLabels': ['Auricularis Magnus Nerve Block']}, {'name': 'Control Group', 'type': 'PROCEDURE', 'description': 'Intravenous analgesics 1 gram paracetamol, 20 mg tenoxicam, 8 mg ondansetron will be administered.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34480', 'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Nur Nazire YUCAL, MD', 'role': 'CONTACT', 'email': 'n_395@hotmail.com', 'phone': '05443898086'}], 'facility': 'Başakşehir Çam and Sakura City Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Nur Nazire YUCAL, MD', 'role': 'CONTACT', 'email': 'n_395@hotmail.com', 'phone': '05443898086'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kocaeli University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Başakşehir Çam & Sakura City Hospital', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Nur Nazire Yucal', 'investigatorAffiliation': 'Başakşehir Çam & Sakura City Hospital'}}}}