Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2026-02-25 @ 11:04 PM
Study NCT ID:
NCT03769818
Status:
COMPLETED
Last Update Posted:
2020-08-05
First Post:
2018-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Dexamethasone for Erector Spinae Plane Block in Patients Undergoing Total Abdominal Hysterectomy
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': "Participating patients, surgeons, anesthesiologists and medical investigators who will be involved in the data collection will be all blinded to the patient's group assignment until the collection of data for all cases will be complete for group 1 and 2."}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A prospective Randomized Interventional double-blind study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-03', 'studyFirstSubmitDate': '2018-12-06', 'studyFirstSubmitQcDate': '2018-12-06', 'lastUpdatePostDateStruct': {'date': '2020-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual analog score for pain during movement', 'timeFrame': '24 hours post operative', 'description': 'movement-evoked pain measurements ranging from 0 to 10, where 0 no pain and 10 maximum pain'}], 'secondaryOutcomes': [{'measure': 'Visual analog score for pain during rest', 'timeFrame': '24 hours postoperative', 'description': 'ranging from 0 to 10, where 0 no pain and 10 maximum pain'}, {'measure': 'number of patients need Fentanyl consumption', 'timeFrame': '24 hours postoperative', 'description': 'calculation of the number of patients need Fentanyl consumption'}, {'measure': 'number of days patients stay in hospital', 'timeFrame': '4 weeks', 'description': 'calculation of number of days patients stay in hospital'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['erector spinae plane block', 'total abdominal hysterectomy', 'dexamethasone'], 'conditions': ['Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'The aim to study the efficacy of bupivacaine 0.25% with dexamethasone and that of bupivacaine 0.25% alone for erector spinae plane block for postoperative analgesia in patients undergoing total abdominal hysterectomy Group 1: bupivacaine 0.25% + dexamethasone 8 mg\n\n* Group 2: bupivacaine 0.25%\n* Group3: control group A prospective Randomized Interventional double-blind study.', 'detailedDescription': 'Optimal dynamic analgesia is recognized as the key to enhanced recovery following open abdominal surgery. In the last decade, there has been a significant shift away from thoracic epidural analgesia (TEA) that has been long considered as the gold standard. Various techniques have tried to replicate the analgesic efficacy of TEA. They include transversus abdominis plane analgesia (TAP), rectus sheath analgesia (RS), wound infusion analgesia (WI) and trans muscular quadratus lumborum analgesia. However, each of these techniques has specific limitations that prevent them from being the analgesic technique of choice for all open abdominal surgeries. Chin et al first described the erector spinae plane (ESP) block for providing analgesia following ventral hernia repair. The unique feature of the ultrasound-guided truncal blocks is that in all of these techniques, in contrast to peripheral nerve blocks, no nerve or plexus needs to be identified: Local anesthesia (LA) is injected in a particular muscle plane, in which the injectate spreads and reaches the intended nerves. This simple mechanism has made delivery of nerve blocks easy and versatile.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'genderBased': True, 'genderDescription': 'patients undergoing total abdominal hysterectomy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women ranging age between 30-60 years a who undergoing elective total abdominal hysterectomy\n\nExclusion Criteria:\n\n* Participants had known sensitivity to bupivacaine\n* Participants had difficulty in intubation\n* Participants were on chronic pain medication or already on long-term opioids\n* Participants smokers\n* Participants with disabilities who were unable to communicate pain levels\n* refuse to consent'}, 'identificationModule': {'nctId': 'NCT03769818', 'briefTitle': 'Role of Dexamethasone for Erector Spinae Plane Block in Patients Undergoing Total Abdominal Hysterectomy', 'organization': {'class': 'OTHER', 'fullName': 'Aswan University Hospital'}, 'officialTitle': 'Role of Adjuvant Dexamethasone for Erector Spinae Plane Block for Postoperative Analgesia in Patients Undergoing Total Abdominal Hysterectomy: A Randomized, Double-blind Controlled Trial', 'orgStudyIdInfo': {'id': 'aswu/181/18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'bupivacaine and dexamethasone', 'description': 'Bilateral ESP block with 20 ml of 0.25% bupivacaine + 4 mg/kg dexamethasone diluted with isotonic saline.', 'interventionNames': ['Drug: bupivacaine', 'Drug: dexamethasone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'bupivacaine and placebo to dexamethasone', 'description': 'Bilateral ESP block with 20 ml of 0.25% bupivacaine bilaterally plus placebo to dexamethasone', 'interventionNames': ['Drug: bupivacaine', 'Drug: placebo to dexamethasone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control group', 'description': 'Bilateral ESP block with placebo to bupivacaine bilaterally plus placebo to dexamethasone', 'interventionNames': ['Drug: placebo to dexamethasone', 'Drug: placebo to bupivacaine']}], 'interventions': [{'name': 'bupivacaine', 'type': 'DRUG', 'otherNames': ['Active Comparator'], 'description': 'Bilateral TAP block with 20 ml of 0.25% bupivacaine', 'armGroupLabels': ['bupivacaine and dexamethasone', 'bupivacaine and placebo to dexamethasone']}, {'name': 'dexamethasone', 'type': 'DRUG', 'otherNames': ['active comparator'], 'description': 'Bilateral TAP block with 4 mg/kg dexamethasone diluted with isotonic saline.', 'armGroupLabels': ['bupivacaine and dexamethasone']}, {'name': 'placebo to dexamethasone', 'type': 'DRUG', 'description': 'Bilateral TAP block with placebo to dexamethasone.', 'armGroupLabels': ['bupivacaine and placebo to dexamethasone', 'control group']}, {'name': 'placebo to bupivacaine', 'type': 'DRUG', 'description': 'Bilateral TAP block with placebo to bupivacaine.', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81528', 'city': 'Aswān', 'country': 'Egypt', 'facility': 'Aswan University', 'geoPoint': {'lat': 24.09082, 'lon': 32.89942}}], 'overallOfficials': [{'name': 'hany f sallam, md', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aswan University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aswan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'hany farouk', 'investigatorAffiliation': 'Aswan University Hospital'}}}}