Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2025-12-26 @ 1:49 AM
Study NCT ID:
NCT04969705
Status:
COMPLETED
Last Update Posted:
2022-07-01
First Post:
2021-07-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intrathecal Dexmedetomidine Versus Transversus Abdominus Plane Block (TAP) for Postoperative Analgesia After Cesarean Section.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-05-12', 'releaseDate': '2022-07-03'}], 'estimatedResultsFirstSubmitDate': '2022-07-03'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-27', 'studyFirstSubmitDate': '2021-07-13', 'studyFirstSubmitQcDate': '2021-07-16', 'lastUpdatePostDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Analgesic efficacy of both routes', 'timeFrame': '24 hours', 'description': 'Demographic data (age, weight, and length), mean arterial blood pressure (MAP), and heart rate (HR) will be measured every 5 minutes intraoperatively and at 1, 2, 4, 6, 8,12,16,20 and 24 h postoperatively. Visual analog pain score (VAS) between 0 and 10 (0=no pain, 1-3=mild pain, 4-6=moderate pain, and 7-10=severe pain) will be recorded at 1, 2, 4, 6, 8,16,20 and 24 h postoperatively. First time of rescue analgesia: this is defined as the time from onset of sensory block till the time of first requirement of analgesia. The total amount of rescue analgesia consumption in the form of intravenous ketorolac→0.5 mg/kg if VAS greater than or equal to 4. Any undesirable postoperative side effects (as nausea, vomiting and pruritus) will be recorded and managed.'}], 'secondaryOutcomes': [{'measure': '1. Hemodynamic effect on the patient', 'timeFrame': '1 hour', 'description': 'measuring BP , HR , oxygen saturation during operation every 5 minutes'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain Management in Adult Females in Child Bearing Period Aging From 20 to 45 Years Who Are Scheduled for Elective Cesarean Section']}, 'referencesModule': {'references': [{'pmid': '17302638', 'type': 'BACKGROUND', 'citation': 'Betran AP, Merialdi M, Lauer JA, Bing-Shun W, Thomas J, Van Look P, Wagner M. Rates of caesarean section: analysis of global, regional and national estimates. Paediatr Perinat Epidemiol. 2007 Mar;21(2):98-113. doi: 10.1111/j.1365-3016.2007.00786.x.'}, {'pmid': '18719619', 'type': 'BACKGROUND', 'citation': 'Madadi P, Ross CJ, Hayden MR, Carleton BC, Gaedigk A, Leeder JS, Koren G. Pharmacogenetics of neonatal opioid toxicity following maternal use of codeine during breastfeeding: a case-control study. Clin Pharmacol Ther. 2009 Jan;85(1):31-5. doi: 10.1038/clpt.2008.157. Epub 2008 Aug 20.'}, {'pmid': '18299097', 'type': 'BACKGROUND', 'citation': 'Elia N, Culebras X, Mazza C, Schiffer E, Tramer MR. Clonidine as an adjuvant to intrathecal local anesthetics for surgery: systematic review of randomized trials. Reg Anesth Pain Med. 2008 Mar-Apr;33(2):159-67. doi: 10.1016/j.rapm.2007.10.008.'}]}, 'descriptionModule': {'briefSummary': 'Spinal anesthesia is the most commonly used technique for lower abdominal surgeries as it is very economical and easy to administer. However, postoperative pain control is a major problem because spinal anesthesia using only local anesthetics is associated with relatively short duration of action, and thus early analgesic intervention is needed in the postoperative period The transversus abdominus plane (TAP) block is a regional analgesic technique which blocks T6-L1 nerve branches and has an evolving role in postoperative analgesia for lower abdominal surgeries'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ASA physical status classes I and II\n2. Scheduled for elective cesarean section\n3. Aged between 20-45 years .\n\nExclusion Criteria:\n\n1. patient refusal.\n2. patient with significant cardiovascular disease , hepatic dysfunction , renal failure , chronic pulmonary disease .\n3. neuromuscular disorder.\n4. infection.\n5. bleeding disorder.\n6. Obesity ( BMI \\> 30 kg/m2 ) .\n7. History of allergy or sensitivity to any of the study drugs in previous surgeries .'}, 'identificationModule': {'nctId': 'NCT04969705', 'briefTitle': 'Intrathecal Dexmedetomidine Versus Transversus Abdominus Plane Block (TAP) for Postoperative Analgesia After Cesarean Section.', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Intrathecal Dexmedetomidine Versus Transversus Abdominus Plane Block (TAP) for Postoperative Analgesia After Cesarean Section.', 'orgStudyIdInfo': {'id': 'Soh-Med-21-07-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A (spinal Dexmedetomidine)', 'description': '. Spinal needles (22 G) will be introduced in sitting position after skin disinfection with povidine iodine, iliac crest will be palpated and thumb extended to meet the midline, feeling the space between L4 and L5. spinal needle penetrates through the dura matter, a pop will be felt and then after the needle puncture into the subarachnoid space and the appearance of clear cerebrospinal fluid, the intrathecal local anesthetic will be injected. All patients will be receiving 2 ml heavy bupivacaine 0.5% plus 5 µg dexmedetomidine to total volume of 2.5 ml.', 'interventionNames': ['Drug: Dexmedetomidine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B (spinal with transversus abdominus plane block)', 'description': 'Spinal needles (22 G) introduced in sitting position . patients receiving1.7 to 2.2 ml heavy bupivacaine 0.5%( according to weight and height ) + 1 ml normal saline = total volume of 2.5 ml then at surgery end under sonographic guide transducer placed in transverse plane above iliac crest.A 90 mm 22 G short beveled block needle inserted in-plane with transducer, in anterior-posterior direction. needle connected to syringe contains20 ml of bupivacaine 0.25%+10 µg dexmedetomidine to deposit local anesthetic deep into the fascial layer between internal oblique \\& transversus abdominis muscles on each side.', 'interventionNames': ['Drug: Dexmedetomidine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group C ( controlled group ) Spinal Anesthesia only :', 'description': 'Patients will be anesthetized only with spinal anesthesia using Bupivacaine Hcl( 10 mg).', 'interventionNames': ['Drug: Dexmedetomidine']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'description': '60 Patients will be randomly divided into three equal groups:\n\nGroup A (n=20) : spinal anesthesia with Dexmedetomidine (5µg ) added to local anesthetic (bupivacaine Hcl ) (10 mg) given intrathecally .\n\nGroup B (n=20) : spinal anesthesia using local anesthetic( bupivacaine Hcl) (20 mg) combined with TAP block using Dexmedetomidine (20µg ) after the cesarean section\n\nGroup C (n=20) (controlled group ) : Spinal anesthesia using only local anesthetic (bupivacaine Hcl ) (10 mg) .', 'armGroupLabels': ['Group A (spinal Dexmedetomidine)', 'Group B (spinal with transversus abdominus plane block)', 'Group C ( controlled group ) Spinal Anesthesia only :']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'country': 'Egypt', 'facility': 'Sohag University Hospital', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident doctor', 'investigatorFullName': 'Dina Mostafa Helmy', 'investigatorAffiliation': 'Sohag University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-07-03', 'type': 'RELEASE'}, {'date': '2023-05-12', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Dina Mostafa Helmy, resident doctor, Sohag University'}}}}