Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-25 @ 9:56 PM
Study NCT ID:
NCT04974658
Status:
COMPLETED
Last Update Posted:
2022-12-13
First Post:
2021-07-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Analgesic Efficacy of the Novel Intra- Semispinal Fascial Plane Block in Posterior Cervical Spine Surgery
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': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Randomization assignments will be kept in sealed envelopes until all preprocedural measurements will be completed, and then they are opened by the research anesthesiologist immediately prior to the nerve block.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study will be performed in neurosurgical operating rooms at Zagazig University Hospitals and included 52 patients allocated randomly into two groups: 26 patients recruited in the block group (I) for the Inter-semispinal plane block and 26 patients recruited in the (C) control group.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-07-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-09', 'studyFirstSubmitDate': '2021-07-14', 'studyFirstSubmitQcDate': '2021-07-22', 'lastUpdatePostDateStruct': {'date': '2022-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total morphine consumed for 24 hours postoperative will be calculated.', 'timeFrame': 'Total morphine consumed up to 24 hours postoperative', 'description': 'Calculation of total morphine that will be used postoperatively. Postoperative morphine will be considered if the postoperative VAS score \\>3 or the patient requested additional analgesia. Rescue analgesia of intravenous morphine will be given'}], 'secondaryOutcomes': [{'measure': 'Total fentanyl consumed intraoperative will be calculated', 'timeFrame': 'total fentanyl dose that will be used for entire operative time.', 'description': 'Total intraoperative fentanyl consumption including the induction doses (1mic/ kg) plus the additional doses of fentanyl (from 0.5 to 1 mic) that will be given if heart rate or blood pressure increases above 20%.'}, {'measure': 'postoperative pain will be assessed using the Numerical Pain Score (NRS) score', 'timeFrame': 'NRS will be recorded 24 hours postoperative.', 'description': 'Numerical Pain Score (NRS) ranges from 0 to 10, where 0 is no pain, and 10 is the worst pain imaginable. Adequate pain control will be considered at Numerical Pain Score (NRS) \\< 4.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cervical Spine Surgery']}, 'referencesModule': {'references': [{'pmid': '29433034', 'type': 'BACKGROUND', 'citation': 'Ohgoshi Y, Kubo EN. Inter-semispinal plane block for cervical spine surgery. J Clin Anesth. 2018 May;46:94-95. doi: 10.1016/j.jclinane.2018.02.007. Epub 2018 Feb 9. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Posterior cervical spine surgery often requires a large posterior midline incision, resulting in poorly controlled postoperative pain, which arises from iatrogenic mechanical damage, intraoperative retraction, and resection to structures such as bone, ligaments, muscles, intervertebral discs, and zygapophysial joints.', 'detailedDescription': 'Ultrasound-guided Inter-semispinal plane (ISP) block, was proposed as a novel technique for analgesia in posterior cervical spine surgeries. The ISP block involves an injection of local anesthetic into the fascial plane between the semispinalis cervicis and semispinal capitis muscles and results in blocking the dorsal rami of the cervical spinal nerves. ISP block can provide effective analgesia in posterior cervical spine surgery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients' acceptance.\n* ASA I , II andIII .\n* Age between 18 years up to 70 years in both sexes.\n* Patients with a BMI (body mass index) ranging from 18.5 to 30 kg/m2.\n* Patients who scheduled for elective posterior cervical spine surgeries\n\nExclusion Criteria:\n\n* Uncooperative patients\n* Coagulopathy.\n* Local tissue infection.\n* Allergy to local anesthesia."}, 'identificationModule': {'nctId': 'NCT04974658', 'briefTitle': 'Analgesic Efficacy of the Novel Intra- Semispinal Fascial Plane Block in Posterior Cervical Spine Surgery', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Zagazig University'}, 'officialTitle': 'Analgesic Efficacy of the Novel Intra- Semispinal Fascial Plane Block in Posterior Cervical Spine Surgery', 'orgStudyIdInfo': {'id': '#6955'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'The block group (ISP)', 'description': 'After aseptic preparation of the injection area, the needle will be introduced in-plane through the skin and advanced into the fascial plane between the semispinalis cervicis and semispinalis capitis muscles. After negative aspiration for blood, 20 ml of 0.25% bupivacaine on each side will be injected for each block.', 'interventionNames': ['Procedure: Inter-semispinal plane block']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control group (C)', 'description': 'No block will be performed', 'interventionNames': ['Procedure: Inter-semispinal plane block']}], 'interventions': [{'name': 'Inter-semispinal plane block', 'type': 'PROCEDURE', 'otherNames': ['No block intervention in control group'], 'description': 'Ultrasound Inter-semispinal plane block in block group', 'armGroupLabels': ['The block group (ISP)', 'control group (C)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44519', 'city': 'Zagazig', 'country': 'Egypt', 'facility': 'Faculty of Medicine, Zagazig University', 'geoPoint': {'lat': 30.58768, 'lon': 31.502}}, {'zip': '44519', 'city': 'Zagazig', 'country': 'Egypt', 'facility': 'Faculty of medicine', 'geoPoint': {'lat': 30.58768, 'lon': 31.502}}], 'overallOfficials': [{'name': 'Naglaa F Abdelhaleem, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of medicine, Zagazig University Hospitals'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'After one year from publishing to a journal', 'ipdSharing': 'YES', 'description': 'Data will be available on permission'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zagazig University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer, Anesthesia and Surgical Intensive Care department, Faculty of Medicine', 'investigatorFullName': 'Naglaa Fathy Abdelhaleem Abdelhaleem', 'investigatorAffiliation': 'Zagazig University'}}}}