Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2025-12-26 @ 3:20 AM
Study NCT ID:
NCT03767920
Status:
COMPLETED
Last Update Posted:
2020-08-05
First Post:
2018-12-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Role of Dexamethasone in Transversus Abdominis Plane Block After Cesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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."}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A prospective Randomized Interventional double-blind study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, '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': '2018-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual analog score for pain during movement', 'timeFrame': '6 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 during rest', 'timeFrame': '48 hours postoperative', 'description': 'ranging from 0 to 10, where 0 no pain and 10 maximum pain'}, {'measure': 'number of patients need Fentanyl consumption', 'timeFrame': '48 hours postoperative', 'description': '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': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dexamethasone', 'transversus abdominis plane block', 'cesarean section'], 'conditions': ['Cesarean Section']}, 'descriptionModule': {'briefSummary': 'Our aim to study the efficacy of bupivacaine 0.25% with dexamethasone and that of bupivacaine 0.25% alone in transversus abdominis plane (TAP) block for postoperative analgesia in patients undergoing an elective Caesarean section.\n\n* Group 1: bupivacaine 0.25% + dexamethasone 8 mg\n* Group 2: bupivacaine 0.25% A prospective Randomized Interventional double-blind study.', 'detailedDescription': 'The pain and discomfort following cesarean delivery are mostly due to the abdominal wall incision and dissection of muscles; it delays early ambulation and breastfeeding. This can lead to postoperative complications such as thromboembolic disorders. So, providing an effective and safe postoperative analgesic method seems to be mandatory. Opioid analgesia remains the most effective means of relieving pain in a wide variety of conditions; however, it may cause adverse effects such as nausea, vomiting, pruritus, urinary retention, and respiratory depression. As the analgesia and the side effects of opioids are dose-dependent, a multimodal approach may enhance analgesia, which in turn would decrease the side effects .\n\nMc Donnell and colleagues have reported that a transversus abdominis plane (TAP) block can decrease the postoperative pain following abdominal surgery. The landmarks of this block were first described in 2001 by Rafi. The TAP block has been performed for postoperative analgesic control in patients undergoing radical prostatectomy, hysterectomy, cesarean delivery under spinal anesthesia, and laparoscopic surgery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'healthy parturient scheduled to undergo LSCS under spinal anesthesia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy parturient (ASA I and II) scheduled to undergo LSCS under spinal anesthesia\n\nExclusion Criteria:\n\n* Participants had known sensitivity to bupivacaine\n* patient refusal,\n* localized infection over injection point\n* patients with significant coagulopathies and\n* with contraindications to regional anesthesia,\n* patients with heart diseases, altered renal or liver functions,\n* psychological disorders, patients with pregnancy-induced hypertension and\n* gestational diabetes, chronic use of pain medications,'}, 'identificationModule': {'nctId': 'NCT03767920', 'briefTitle': 'Role of Dexamethasone in Transversus Abdominis Plane Block After Cesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'Aswan University Hospital'}, 'officialTitle': 'Role of Co-administered Dexamethasone in Transversus Abdominis Plane Block After Cesarean Section: A Randomized, Double-blind Controlled Trial', 'orgStudyIdInfo': {'id': 'aswu/180/7/18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'bupivacaine and dexamethasone', 'description': 'Bilateral TAP 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': 'BilateralTAP block with 20 ml of 0.25% bupivacaine bilaterally plus placebo to dexamethasone', 'interventionNames': ['Drug: bupivacaine', 'Drug: placebo to dexamethasone']}], 'interventions': [{'name': 'bupivacaine', 'type': 'DRUG', 'otherNames': ['Active Comparator'], 'description': 'TAP block with 20 ml of 0.25% bupivacaine bilaterally', 'armGroupLabels': ['bupivacaine and dexamethasone', 'bupivacaine and placebo to dexamethasone']}, {'name': 'dexamethasone', 'type': 'DRUG', 'otherNames': ['active comparator'], 'description': 'TAP block with 4 mg dexamethasone bilaterally', 'armGroupLabels': ['bupivacaine and dexamethasone']}, {'name': 'placebo to dexamethasone', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'TAP block with 4 mg placebo to dexamethasone bilaterally', 'armGroupLabels': ['bupivacaine and placebo to dexamethasone']}]}, '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': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aswan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'hany farouk', 'investigatorAffiliation': 'Aswan University Hospital'}}}}