Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-27 @ 11:19 PM
Study NCT ID:
NCT05590234
Status:
COMPLETED
Last Update Posted:
2023-07-21
First Post:
2022-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dexmedetomidine Combined With Bupivacaine for Erector Spinae Plane Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-20', 'studyFirstSubmitDate': '2022-10-17', 'studyFirstSubmitQcDate': '2022-10-20', 'lastUpdatePostDateStruct': {'date': '2023-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative visual analogue scale (VAS)', 'timeFrame': 'the first 24 hours postoperative', 'description': 'The visual analog scale (VAS) is a simple and often used method for evaluating variations in pain intensity.'}, {'measure': 'Amount of post operative opioid consumption for the first 24 hours', 'timeFrame': 'the first 24 hours postoperative', 'description': 'Amount of total opioid consumption for 24 hours postoperative'}], 'secondaryOutcomes': [{'measure': 'Postoperative visual analogue scale (VAS)', 'timeFrame': 'the second 24 hour postoperative', 'description': 'The visual analog scale (VAS) is a simple and often used method for evaluating variations in pain intensity.'}, {'measure': 'Amount of post operative opioid consumption for the second 24 hours', 'timeFrame': 'the second 24 hour postoperative', 'description': 'Amount of total opioid consumption for the second 24 hours postoperative'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Posterior Lumbosacral Spine Fixation Surgeries']}, 'referencesModule': {'references': [{'pmid': '38344257', 'type': 'DERIVED', 'citation': 'Abu El Hassan SHA, Wahsh EA, Mousa AM, Ibrahim ARN, Mohammed EL. Comparative Study Between Dexmedetomidine with Bupivacaine and Bupivacaine Alone in Erector Spinae Plane Block for Postoperative Pain Control of Posterior Lumbosacral Spine Fixation Surgeries: A Randomized Controlled Trial. Drug Des Devel Ther. 2024 Feb 7;18:351-363. doi: 10.2147/DDDT.S444485. eCollection 2024.'}]}, 'descriptionModule': {'briefSummary': 'As the posterior lumbosacral spine fixation surgeries are common spine procedures done nowadays due to different causes and as this spine procedure is mostly accompanied with moderate to severe postoperative pain, so it is necessary to find an effective and efficient postoperative analgesia for patients with this surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* elective posterior lumbosacral spine fixation and fusion surgery due to different causes that diagnosed clinically and radiologically including MRI and Plain X ray\n\nExclusion Criteria:\n\n* hypersensitivity to the drugs used in the study \\[local anesthetics, non-steroidal anti-inflammatory drugs, opioids and the drug under investigation (dexmedetomidine)\\]\n* patients with any contraindication to regional anesthesia as skin infections at the site of the block\n* history of bleeding disorders or receiving anticoagulant medications'}, 'identificationModule': {'nctId': 'NCT05590234', 'briefTitle': 'Dexmedetomidine Combined With Bupivacaine for Erector Spinae Plane Block', 'organization': {'class': 'OTHER', 'fullName': 'October 6 University'}, 'officialTitle': 'Dexmedetomidine Combined With Bupivacaine for Erector Spinae Plane Block Versus Bupivacaine Alone for Postoperative Pain Control of Posterior Lumbosacral Spine Fixation Surgeries', 'orgStudyIdInfo': {'id': 'PRC-Me-2210035'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dexmedetomidine combined with bupivacaine group (DB group)', 'description': 'patients received 1ug/kg dexmedetomidine plus 20 mL of bupivacaine 0.25%,', 'interventionNames': ['Drug: Dexmedetomidine injection', 'Drug: Bupivacaine 0.25% Injectable Solution']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'bupivacaine 0.25%,', 'description': 'patients received 20 ml of bupivacaine 0.25%', 'interventionNames': ['Drug: Bupivacaine 0.25% Injectable Solution']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control group (S group)', 'description': 'patients received 20 ml of normal saline 0.9%.', 'interventionNames': ['Drug: normal saline']}], 'interventions': [{'name': 'Dexmedetomidine injection', 'type': 'DRUG', 'description': '1ug/kg dexmedetomidine plus 20 mL of bupivacaine 0.25%', 'armGroupLabels': ['Dexmedetomidine combined with bupivacaine group (DB group)']}, {'name': 'Bupivacaine 0.25% Injectable Solution', 'type': 'DRUG', 'description': '20 ml of bupivacaine 0.25%,', 'armGroupLabels': ['Dexmedetomidine combined with bupivacaine group (DB group)', 'bupivacaine 0.25%,']}, {'name': 'normal saline', 'type': 'DRUG', 'description': '20 ml of normal saline 0.9%.', 'armGroupLabels': ['control group (S group)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12573', 'city': 'Giza', 'country': 'Egypt', 'facility': 'October 6 university hospital', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'overallOfficials': [{'name': 'Abdelmaksod Mohammed M Mousa, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'October 6 University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'October 6 University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of clinical pharmacy', 'investigatorFullName': 'engy wahsh', 'investigatorAffiliation': 'October 6 University'}}}}