Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-25 @ 3:58 PM
Study NCT ID:
NCT05850468
Status:
UNKNOWN
Last Update Posted:
2023-05-09
First Post:
2023-03-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Combining Erector Spinea Block With Non Opioid Infusions as Opioid Free Anesthesia in Spine Surgeries.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-29', 'studyFirstSubmitDate': '2023-03-18', 'studyFirstSubmitQcDate': '2023-04-29', 'lastUpdatePostDateStruct': {'date': '2023-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of patients (percentage) having intraoperative systolic hypertension', 'timeFrame': 'during operation(intraoperatively)', 'description': 'blood pressure more than 160 mmhg'}, {'measure': 'number of patients(percentage) having tachycardia', 'timeFrame': 'during operation(intraoperatively)', 'description': 'heart rate more than 100 beat /minute'}], 'secondaryOutcomes': [{'measure': 'VAS score', 'timeFrame': 'every 30 minutes for 2 hours postoperatively', 'description': 'score from 0 to 10, 0 is no pain and 10 the worst pain'}, {'measure': 'incidence of bradycardia', 'timeFrame': 'intraoperatively', 'description': 'heart rate less than 45 beat per minute'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['multimodal analgesia, regional blocks, spine surgeries'], 'conditions': ['Opioid Use', 'Spine Fusion']}, 'referencesModule': {'references': [{'pmid': '5285383', 'type': 'BACKGROUND', 'citation': 'Rowland M, Thomson PD, Guichard A, Melmon KL. Disposition kinetics of lidocaine in normal subjects. Ann N Y Acad Sci. 1971 Jul 6;179:383-98. doi: 10.1111/j.1749-6632.1971.tb46915.x. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'opioid free anesthesia consists of combination of pharmacological and non pharmacological modalities that target different pathways of pain mechanism. combining myofascial plane blocks with infusion of adjuvants such as lidocaine or dexmedetomidine can offer equivalent intraoperative hemodynamic stability compared to that of opioid with better pain control postoperatively. this study will investigate the efficacy of combined erector spina block with lidocaine and dexmedetomidine infusion as opioid sparing anesthesia in spine surgeries', 'detailedDescription': 'patients who will undergo spine surgery will be allocated into two groups. after general anesthesia, bilateral erector spine block will be applied in both groups. group A will have intraoperative fentanyl infusion and group B will have lidocaine and dexmedetomidine infusion in 50 ml syringe till end of surgery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- spine surgery ASAI,II\n\nExclusion Criteria:\n\n* revision surgery hypotension bradycardia'}, 'identificationModule': {'nctId': 'NCT05850468', 'briefTitle': 'Effectiveness of Combining Erector Spinea Block With Non Opioid Infusions as Opioid Free Anesthesia in Spine Surgeries.', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Assistant Professor of Anesthesia, Intensive Care and Pain Management', 'orgStudyIdInfo': {'id': 'MS81/2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'traditinal balanced anesthesia', 'description': 'fentanyl infusion after general anesthesia and erector spinea block', 'interventionNames': ['Drug: fentanyl infusion after general anesthesia and erector spinea block']}, {'type': 'EXPERIMENTAL', 'label': 'opioid free anesthesia', 'description': 'lidocaine and dextometidine infusion after general anesthesia and erector spinea block', 'interventionNames': ['Drug: lidocaine 2% and dextometometidine infusion after general anesthesia and erector spinea block']}], 'interventions': [{'name': 'fentanyl infusion after general anesthesia and erector spinea block', 'type': 'DRUG', 'otherNames': ['opioid infusion'], 'description': 'intraoperative opioid infusion in active comparative group', 'armGroupLabels': ['traditinal balanced anesthesia']}, {'name': 'lidocaine 2% and dextometometidine infusion after general anesthesia and erector spinea block', 'type': 'DRUG', 'otherNames': ['lidocaine 2% and precedex infusion'], 'description': 'intraoperative non opioid infusion in experimental group', 'armGroupLabels': ['opioid free anesthesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11591', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ainshams hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'sanaa wasfy, professor', 'role': 'CONTACT', 'email': 'sanaawasfy@gmail.com', 'phone': '01061262757'}, {'name': 'wael behairy, professor', 'role': 'CONTACT', 'email': 'wailbehairy@yahoo.com', 'phone': '01282269727'}], 'overallOfficials': [{'name': 'sanaa wasfy, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'assistant professor of anesthesia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}