Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:38 PM
Study NCT ID:
NCT07170267
Status:
RECRUITING
Last Update Posted:
2025-09-16
First Post:
2025-09-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Transversalis Fascia Plane Block Versus Intrathecal Dexmedetomidine in Patients Undergoing Cesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-13', 'studyFirstSubmitDate': '2025-09-06', 'studyFirstSubmitQcDate': '2025-09-06', 'lastUpdatePostDateStruct': {'date': '2025-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Degree of pain', 'timeFrame': '24 hours postoperatively', 'description': 'Each patient will be instructed about postoperative pain assessment with the numeric rating scale (NRS) score. NRS (0 represents "no pain" while 10 represents "the worst pain imaginable"). NRS will be assessed at post-anesthesia care unit (PACU), 2, 4, 6, 8, 12, 18 and 24 h postoperatively.'}], 'secondaryOutcomes': [{'measure': 'Total morphine consumption', 'timeFrame': '24 hours postoperatively', 'description': 'Rescue analgesia of morphine will be given as 3 mg bolus if the numeric rating scale (NRS) \\> 3 to be repeated after 30 min if pain persists until the NRS \\< 4.'}, {'measure': 'Time to the 1st rescue analgesia', 'timeFrame': '24 hours postoperatively', 'description': 'Time to the first request for the rescue analgesia will be recorded from the end of surgery to first dose of morphine administrated.'}, {'measure': 'Mean arterial pressure', 'timeFrame': 'Till the end of surgery (Up to 2 hours)', 'description': 'Mean arterial pressure will be recorded preoperatively and every 30 minutes till the end of surgery.'}, {'measure': 'Heart rate', 'timeFrame': 'Till the end of surgery (Up to 2 hours)', 'description': 'Heart rate will be recorded preoperatively and every 30 minutes till the end of surgery.'}, {'measure': 'Incidence of adverse events', 'timeFrame': '24 hours postoperatively', 'description': 'Incidence of adverse events such as bradycardia, hypotension, nausea, vomiting, respiratory depression, or any other complication will be recorded.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Transversalis Fascia Plane Block', 'Intrathecal Dexmedetomidine', 'Cesarean Section']}, 'descriptionModule': {'briefSummary': 'This study aims to compare the analgesic efficacy of the transversalis fascia plane (TFP) block and intrathecal dexmedetomidine in patients undergoing cesarean section (CS).', 'detailedDescription': 'Cesarean section (CS) is a commonly performed major surgical procedure that results in substantial postoperative pain and patient dissatisfaction.\n\nSpinal anesthesia is commonly used in CS surgery. However, it may be associated with several side effects, particularly hypotension.\n\nDexmedetomidine is an α2 adrenergic receptor agonist that has an analgesic effect.\n\nUltrasound-guided interfascial plane blocks are often used in multimodal analgesia regimens. Local anaesthetic injection into the transversalis fascia plane (TFP) anesthetizes the proximal branches of T12 and L1 which targeted in the plane between the transversus abdominis muscle and the transversalis fascia.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Women undergoing cesarean section', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age from 18 to 40 years.\n* American Society of Anesthesiology (ASA) physical status II.\n* Women undergoing cesarean section under spinal anesthesia.\n\nExclusion Criteria:\n\n* Contraindication to spinal anesthesia.\n* Women with body mass index \\>40 kg/m2.\n* Pregnancy-induced hypertension\n* Local infection at the site of injection.\n* Known cardiovascular disease\n* Coagulation abnormality.\n* History of chronic pain.\n* Abuse of drugs or alcohol.\n* History of allergies to any study medications.\n* Seizure disorders.\n* Any pregnancy complications requiring conversion to general anesthesia.'}, 'identificationModule': {'nctId': 'NCT07170267', 'briefTitle': 'Transversalis Fascia Plane Block Versus Intrathecal Dexmedetomidine in Patients Undergoing Cesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Analgesic Efficacy of Transversalis Fascia Plane Block Versus Intrathecal Dexmedetomidine in Patients Undergoing Cesarean Section: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '36264PR1335/8/25'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TFP group', 'description': 'Patients will receive spinal anesthesia (using 2.5 mL of hyperbaric bupivacaine 0.5%) with bilateral transversalis fascia plane (TFP) block (using 20 mL of bupivacaine 0.25%) at the end of surgery.', 'interventionNames': ['Other: Transversalis fascia plane block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Patients will receive spinal anesthesia (using 2.5 mL of hyperbaric bupivacaine 0.5%) + (5 µg intrathecal dexmedetomidine diluted in 0.5ml saline) with a sham block at the end of surgery.', 'interventionNames': ['Drug: Intrathecal dexmedetomidine']}], 'interventions': [{'name': 'Transversalis fascia plane block', 'type': 'OTHER', 'description': 'Patients will receive spinal anesthesia (using 2.5 mL of hyperbaric bupivacaine 0.5%) with bilateral transversalis fascia plane (TFP) block (using 20 mL of bupivacaine 0.25%) at the end of surgery.', 'armGroupLabels': ['TFP group']}, {'name': 'Intrathecal dexmedetomidine', 'type': 'DRUG', 'description': 'Patients will receive spinal anesthesia (using 2.5 mL of hyperbaric bupivacaine 0.5%) + (5 µg intrathecal dexmedetomidine diluted in 0.5ml saline) with a sham block at the end of surgery.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31527', 'city': 'Tanta', 'state': 'El-Gharbia', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mohammed S Elsharkawy, MD', 'role': 'CONTACT', 'email': 'mselsharkawy@med.tanta.edu.eg', 'phone': '00201148207870'}, {'name': 'Saad A Moharam, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'centralContacts': [{'name': 'Mohammed S ElSharkawy, MD', 'role': 'CONTACT', 'email': 'mselsharkawy@med.tanta.edu.eg', 'phone': '00201148207870'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After the end of study for one year.', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of study for one year.', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.', 'investigatorFullName': 'Mohammed Said ElSharkawy', 'investigatorAffiliation': 'Tanta University'}}}}