Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2026-01-03 @ 11:24 PM
Study NCT ID:
NCT05577559
Status:
COMPLETED
Last Update Posted:
2023-12-29
First Post:
2022-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound-Guided Intermediate Cervical Plexus or Cervical Erector Spinae Block for Anterior Cervical Spine Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-22', 'studyFirstSubmitDate': '2022-10-09', 'studyFirstSubmitQcDate': '2022-10-09', 'lastUpdatePostDateStruct': {'date': '2023-12-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The time to first call to rescue analgesia', 'timeFrame': '24 hour postoperative', 'description': 'The time to first call to rescue analgesia (nalbuphine) the time between the end of surgery to first report of postoperative pain. will be recorded.'}], 'secondaryOutcomes': [{'measure': 'The total amount of nalbuphine', 'timeFrame': '24 hour postoperative', 'description': 'The total amount of nalbuphine given to each patient during the first 24h of postoperative period will be recorded'}, {'measure': 'Pain intensity', 'timeFrame': 'up to 24hs postoperative', 'description': '2\\. Pain intensity using Visual Analouge Scale (VAS) (11). A commonly used visual analog scale is a 10-cm line labeled with "worst pain imaginable" on the right border and "no pain" on the left border. The patient is instructed to make a mark along the line to represent the intensity of pain currently being experienced. VAS score will be assessed at 30 minutes, 2hs, 4hs, 6hs, 12hs, and 24hs postoperative and IV increment of 15mg nalbuphine (rescue analgesic) will be given if VAS≥4.'}, {'measure': 'Total intra-operative fentanyl consumption', 'timeFrame': 'intra-operative', 'description': 'Total intra-operative fentanyl consumption by ug excluding induction dose.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Analgesia']}, 'referencesModule': {'references': [{'pmid': '38649826', 'type': 'DERIVED', 'citation': 'Kamel AAF, Fahmy AM, Fathi HM, Elmesallamy WAEA, Khalifa OYA. Regional analgesia using ultrasound-guided intermediate cervical plexus block versus cervical erector spinae block for anterior cervical spine surgery: a randomized trial. BMC Anesthesiol. 2024 Apr 22;24(1):153. doi: 10.1186/s12871-024-02533-6.'}]}, 'descriptionModule': {'briefSummary': '• Neck pain and stiffness or sore throat, are common after anterior cervical spine surgery. Complications are rare but can be serious and even potentially life-threatening if they do occur. Rapid recovery and emergence from general anesthesia are important in cases of anterior cervical spine surgery.', 'detailedDescription': '* Null hypothesis (H0): No difference between the regional analgesia effects of bilateral ultrasound-guided superficial cervical plexus block and bilateral cervical erector spinae block in patients undergoing anterior cervical spine surgery under general anesthesia.\n* Alternative hypothesis (H1): There are differences between the regional analgesia effects of bilateral ultrasound-guided superficial cervical plexus block and bilateral cervical erector spinae block in'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient acceptance.\n* Age (21-60) years old.\n* Both sex\n* American Society of Anesthesiologist physical status I / II\n* Elective anterior cervical spine surgery under general anesthesia.\n* patient With Body Mass Index (BMI) (25-35kg/m²)\n\nExclusion Criteria:\n\n* Local infection at site of puncture.\n* Altered mental status.\n* History of allergy to study drugs ( bupivacaine, fentanyl).\n* Patients with chronic pain.\n* Patients with severe hepatic or kidney impairment.\n* Patients having a history of hematological disorders, including coagulation abnormality.'}, 'identificationModule': {'nctId': 'NCT05577559', 'briefTitle': 'Ultrasound-Guided Intermediate Cervical Plexus or Cervical Erector Spinae Block for Anterior Cervical Spine Surgery', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Zagazig University'}, 'officialTitle': 'Regional Analgesia Using Ultrasound-Guided Intermediate Cervical Plexus Block or Cervical Erector Spinae Block for Anterior Cervical Spine Surgery: A Randomized Trial', 'orgStudyIdInfo': {'id': '9790'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Superficial cervical group', 'description': 'patients will receive bilateral ultrasound guided intermediate cervical plexus block using 15 ml of bupivacaine 0.25% for each side.', 'interventionNames': ['Procedure: intermediate cervical plexus block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Erector spinae group', 'description': 'patients will receive bilateral ultrasound guided cervical erector spinae plane block using 15 ml of bupivacaine 0.25% for each side at the level of C6.', 'interventionNames': ['Procedure: Cervical Erector spinae block']}], 'interventions': [{'name': 'intermediate cervical plexus block', 'type': 'PROCEDURE', 'description': 'patients will receive bilateral ultrasound guided intermediate cervical plexus block using 15 ml of bupivacaine 0.25% for each side.', 'armGroupLabels': ['Superficial cervical group']}, {'name': 'Cervical Erector spinae block', 'type': 'PROCEDURE', 'description': 'patients will receive bilateral ultrasound guided cervical erector spinae plane block using 15 ml of bupivacaine 0.25% for each side at the level of C6.', 'armGroupLabels': ['Erector spinae group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zagazig', 'country': 'Egypt', 'facility': 'Faculty of Human Medicine, Zagazig University', 'geoPoint': {'lat': 30.58768, 'lon': 31.502}}], 'overallOfficials': [{'name': 'Alshaimaa Kamel, MD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zagazig University, Faculty of Human Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zagazig University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor of Anesthesia, Intensive Care and Pain Management', 'investigatorFullName': 'Alshaimaa Abdel Fattah Kamel', 'investigatorAffiliation': 'Zagazig University'}}}}