Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT04371705
Status:
COMPLETED
Last Update Posted:
2020-05-06
First Post:
2020-04-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Ultrasound Guided Erector Spinae Plane Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017060', 'term': 'Patient Satisfaction'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-05', 'studyFirstSubmitDate': '2020-04-27', 'studyFirstSubmitQcDate': '2020-04-30', 'lastUpdatePostDateStruct': {'date': '2020-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative Total Fentanyl Requirement', 'timeFrame': '24 hours', 'description': 'The total amount of postoperative fentanyl in milligram'}], 'secondaryOutcomes': [{'measure': 'Time of First Post Operative Analgesic Request', 'timeFrame': '24 hours', 'description': 'the pain will be assisted based on the time for the first dose of rescue analgesia.'}, {'measure': 'heart rate (HR)', 'timeFrame': '24 hours', 'description': 'Hemodynamic'}, {'measure': 'mean arterial pressure (MAP )', 'timeFrame': '24 hours', 'description': 'Hemodynamic'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ESPB', 'postoperative pain', 'Regional block'], 'conditions': ['Hemodynamic Instability', 'Patient Satisfaction', 'Postoperative Pain', 'Regional Block']}, 'descriptionModule': {'briefSummary': 'Thoracic epidural and paravertebral blocks are the most widely regional technique used for postoperative analgesia after surgery, but they are difficult to perform and carry a risk of serious complication. In this study, investigator asses the efficacy of ultrasound ESPB on intraoperative and postoperative hemodynamics and patient satisfaction', 'detailedDescription': "This prospective, double-blinded, randomized, controlled study was conducted at the period from October 2018 to December 2019. Sixty adults' patients ASA I-III, their ages ranged from 25-60 years undergoing abdominal surgery under general anesthesia. Each patient assigned written informed consent before the block performance.\n\nPatients refused, known allergy to the used drugs, with history of coagulopathy, major organ failure and obesity (BMI\\>40 kg/m2) were excluded from the study.\n\nPatients were randomly allocated into two equal groups by a computerized randomization table: ESPB group, and control group. The patient and the staff providing the postoperative care were blinded to the group assignment.\n\nESPB group: Will undergo ESP block with 40 ml bupivacaine 0.25% (20 ml on each side) control group: anesthetized with the protocol followed by Minia University Hospital.\n\nAnesthetic technique was standardized for all patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age18-70 .\n2. Both gender.\n\n4\\. ASA I-III .\n\nExclusion Criteria:\n\n1. patient refuse\n2. Drug allergy.\n3. Morbid obesity (BMI \\>40 kg/m2).\n4. Psychiatric disorder.\n5. Opioid dependence .'}, 'identificationModule': {'nctId': 'NCT04371705', 'briefTitle': 'Efficacy of Ultrasound Guided Erector Spinae Plane Block', 'organization': {'class': 'OTHER', 'fullName': 'Minia University'}, 'officialTitle': 'Efficacy of Ultrasound Guided Erector Spinae Plane Block in Patients Undergoning Abdominal Surgery', 'orgStudyIdInfo': {'id': 'Efficacy of ESPB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ESPB group', 'description': '31 patients Will undergo ultrasound guided ESP block with 40 ml bupivacaine 0.25% (20 ml on each side).', 'interventionNames': ['Procedure: Erector spinae plane block']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control group', 'description': '31 patients anesthetized with the protocol followed by Minia University Hospital', 'interventionNames': ['Other: control']}], 'interventions': [{'name': 'Erector spinae plane block', 'type': 'PROCEDURE', 'description': 'The ESP block will be performed into a fascial plane between the deep surface of erector spinae muscle and the transverse processes using ultrasound guide.', 'armGroupLabels': ['ESPB group']}, {'name': 'control', 'type': 'OTHER', 'description': 'placebo', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61511', 'city': 'Minya', 'state': 'Minya Governorate', 'country': 'Egypt', 'facility': 'Minia University', 'geoPoint': {'lat': 28.09193, 'lon': 30.75813}}], 'overallOfficials': [{'name': 'Nagy S. Ali, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Minia University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant lecturarl', 'investigatorFullName': 'Hassan Mokhtar Elshorbagy Hetta', 'investigatorAffiliation': 'Minia University'}}}}