Ignite Creation Date:
2025-12-24 @ 1:30 PM
Ignite Modification Date:
2025-12-30 @ 1:19 PM
Study NCT ID:
NCT04749095
Status:
UNKNOWN
Last Update Posted:
2021-02-11
First Post:
2021-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Erector Spinae Plane Block Analgesia for Lumbar Spine Fusion Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-09', 'studyFirstSubmitDate': '2021-02-05', 'studyFirstSubmitQcDate': '2021-02-09', 'lastUpdatePostDateStruct': {'date': '2021-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Analgesia', 'timeFrame': 'Up to 24 hours after surgery', 'description': 'Numerical rating scale of pain every 6 hours'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain, Postoperative']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to investigate the effect of a bilateral ultrasound guided erector spinae plane block on the pain scores and opoid utiliziation in fusion surgery of the lumbar spine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists class I-III adult patients\n* BMI less than or equal 35 kg/m2\n\nExclusion Criteria:\n\n* Patient refusal\n* unable to give consent\n* age \\< 18 or \\> 65\n* BMI more than 35 kg/m2\n* known allergy to the study medication\n* coagulopathies or on anticoagulant medications\n* hepatic insufficiency\n* renal insufficiency\n* chronic opioid use'}, 'identificationModule': {'nctId': 'NCT04749095', 'briefTitle': 'Erector Spinae Plane Block Analgesia for Lumbar Spine Fusion Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Benha University'}, 'officialTitle': 'Can Bilateral Erector Spinae Plane Block Minimize Perioprative Opioid Consumption and Provide Satisfactory Analgesia for Lumbar Spine Fusion Surgery? A Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'erector spinae plane block'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Erector block', 'interventionNames': ['Drug: Erector spinae plane block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'sham block', 'interventionNames': ['Drug: sham subcutaneous infiltration']}], 'interventions': [{'name': 'Erector spinae plane block', 'type': 'DRUG', 'description': 'bilateral ESP block will be injected with 20 ml of 0.25% bupivacaine', 'armGroupLabels': ['Erector block']}, {'name': 'sham subcutaneous infiltration', 'type': 'DRUG', 'description': 'bilateral ESP block will be injected with 20 ml of normal saline', 'armGroupLabels': ['sham block']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Benha University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Baher Said Elshahat Mohamed Abdelhady', 'investigatorAffiliation': 'Benha University'}}}}