Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:01 PM
Study NCT ID:
NCT04318158
Status:
UNKNOWN
Last Update Posted:
2020-03-23
First Post:
2020-03-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dexmedetomidine Versus Fentanyl as Adjuvants to Bupivacaine in Ultrasound Guided Transversus Abdominis Plane Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D005283', 'term': 'Fentanyl'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010880', 'term': 'Piperidines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2021-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-20', 'studyFirstSubmitDate': '2020-03-19', 'studyFirstSubmitQcDate': '2020-03-20', 'lastUpdatePostDateStruct': {'date': '2020-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The time for first rescue analgesia after the TAP block.', 'timeFrame': 'first 24 hours after block.', 'description': 'Postoperative analgesia duration.'}], 'secondaryOutcomes': [{'measure': 'the total dose of rescue analgesia after TAP bock.', 'timeFrame': 'first 24 hours after block.', 'description': 'Postoperative analgesia consumption.'}, {'measure': 'VAS for pain.', 'timeFrame': '0, 2, 4, 6, 12 and 24 hours postoperatively.', 'description': 'Postoperative pain at rest and movement.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dexmedetomidine', 'Fentanyl', 'Bupivacaine', 'Transversus Abdominis Plane Block'], 'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '36344917', 'type': 'DERIVED', 'citation': 'Kassim DY, Mahmoud HE, Fakhry DM, Mansour MA. Comparative study of dexmedetomidine versus fentanyl as adjuvants to bupivacaine in ultrasound-guided transversus abdominis plane block in patients undergoing radical cystectomy: a prospective randomised study. BMC Anesthesiol. 2022 Nov 7;22(1):340. doi: 10.1186/s12871-022-01877-1.'}]}, 'descriptionModule': {'briefSummary': 'The aim and objective of this study is to compare dexmedetomidine and fentanyl as adjuvants to bupivacaine in ultrasound guided TAP block analgesia in patients undergoing radical cystectomy as regarding postoperative analgesic efficacy.', 'detailedDescription': 'Radical cystectomy with pelvic lymph node dissection is the gold standard treatment for muscle invasive bladder cancer and is associated with a high risk of complications. Management of the postoperative pain is important to decrease the length of stay in the hospital and the risk of morbidity. Multimodal analgesia management is utilized for pain observed in the postoperative period.As part of a multimodal analgesic regimen, a peripheral nerve block can decrease opioid consumption, providing more effective analgesia with fewer adverse effects.TAP block is a relatively new regional anesthesia technique that provides analgesia to the parietal peritoneum, as well as skin and muscles of the lower anterior abdominal wall. Dexmedetomidine and fentanyl have been used as adjuvants to local anesthetics in different surgeries to provide superior analgesia and to improve the duration of the block.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Both sexes.\n* ASA grade I and II.\n* Age between 50-70 years.\n* Elective open radical cystectomy.\n\nExclusion Criteria:\n\n* Any history or signs of cardiac, hepatic and renal failure.\n* Patients with coagulopathy or under anticoagulation therapy.\n* Infection near the site of needle insertion.\n* Morbid obesity (BMI\\>40 kg/m2).\n* History of allergic reactions to any of the study medications.\n* Previous abdominal surgery.\n* Patients with any neurological or neuromuscular disorder or history of seizures.'}, 'identificationModule': {'nctId': 'NCT04318158', 'briefTitle': 'Dexmedetomidine Versus Fentanyl as Adjuvants to Bupivacaine in Ultrasound Guided Transversus Abdominis Plane Block', 'organization': {'class': 'OTHER', 'fullName': 'Beni-Suef University'}, 'officialTitle': 'A Comparative Study of Dexmedetomidine Versus Fentanyl as Adjuvants to Bupivacaine in Ultrasound Guided Transversus Abdominis Plane Block in Patients Undergoing Radical Cystectomy', 'orgStudyIdInfo': {'id': 'FMBSUREC/08032020/Fakhry'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group(B)', 'description': 'Patients will receive single shot US guided TAP block using 20 ml bupivacaine 0.25% on each side.', 'interventionNames': ['Drug: Bupivacaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group(BD)', 'description': 'Patients will receive single shot US guided TAP block using 20 ml bupivacaine 0.25% + 50 µg dexmedetomedine on each side.', 'interventionNames': ['Drug: Dexmedetomidine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group(BF)', 'description': 'Patients will receive single shot US guided TAP block using 20 ml bupivacaine 0.25% + 50 µg fentanyl on each side.', 'interventionNames': ['Drug: Fentanyl']}], 'interventions': [{'name': 'Bupivacaine', 'type': 'DRUG', 'otherNames': ['Sunnypivacaine'], 'description': 'single shot US guided TAP block using 20 ml bupivacaine 0.25%.', 'armGroupLabels': ['Group(B)']}, {'name': 'Dexmedetomidine', 'type': 'DRUG', 'otherNames': ['Precedex'], 'description': 'Single shot US guided TAP block using 20 ml bupivacaine 0.25% + 50 µg dexmedetomedine on each side.', 'armGroupLabels': ['Group(BD)']}, {'name': 'Fentanyl', 'type': 'DRUG', 'otherNames': ['Fentanyl hameln'], 'description': 'Single shot US guided TAP block using 20 ml bupivacaine 0.25% + 50 µg fentanyl on each side.', 'armGroupLabels': ['Group(BF)']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beni-Suef University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Management', 'investigatorFullName': 'Dina Mahmoud Fakhry', 'investigatorAffiliation': 'Beni-Suef University'}}}}