Ignite Creation Date:
2025-12-24 @ 7:23 PM
Ignite Modification Date:
2026-01-01 @ 6:36 PM
Study NCT ID:
NCT06820203
Status:
COMPLETED
Last Update Posted:
2025-07-25
First Post:
2025-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Premixed, Sequential and Manually Mixed Administration of Intrathecal Fentanyl and Bupivacaine in Cesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-24', 'studyFirstSubmitDate': '2025-02-06', 'studyFirstSubmitQcDate': '2025-02-06', 'lastUpdatePostDateStruct': {'date': '2025-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to the 1st rescue analgesia', 'timeFrame': '24 hours postoperatively', 'description': 'Time to the first request for the rescue analgesia (time from end of surgery to first dose of pethidine administrated).'}], 'secondaryOutcomes': [{'measure': 'Total analgesic consumption', 'timeFrame': '24 hours postoperatively', 'description': 'The total amount of analgesic the patient will be given within 24 h after spinal anesthesia'}, {'measure': 'Degree of pain', 'timeFrame': '24 hours postoperatively', 'description': 'The degree of pain will be assessed using the numerical rating scale (NRS). NRS (0 represents "no pain" while 10 represents "the worst pain imaginable"). NRS will be assessed at 0, 2, 4, 6, 8, 12, 18, and 24h postoperatively.'}, {'measure': 'Onset of motor block', 'timeFrame': 'Intraoperatively', 'description': 'onset of motor block (defined as the time from giving spinal anesthesia until a modified Bromage score of 3 was reached). The modified Bromage scale \\[0: No motor block, 1: Unable to raise an extended leg (able to flex the knee), 2: Unable to flex the knee (able to move the foot only), 3: Unable to flex the ankle (unable to move the foot or knee)\\]'}, {'measure': 'Duration of motor block', 'timeFrame': 'Intraoperatively', 'description': 'Duration of motor block (defined as the time from the onset of motor blockade until complete recovery, indicated by a Bromage score of 0) will be recorded'}, {'measure': 'Onset of sensory block', 'timeFrame': 'Intraoperatively', 'description': 'Onset of sensory block (time elapsed from the end of spinal injection to absence of pinprick sensation at T10 dermatome).'}, {'measure': 'Duration of sensory block', 'timeFrame': 'Intraoperatively', 'description': 'Duration of sensory block (The time till achieving T10 sensory level in addition to the maximum block height) will be noted and recorded.'}, {'measure': 'Incidence of complications', 'timeFrame': '24 hours postoperatively', 'description': 'Incidence of complications such as bradycardia, hypotension, nausea, Pruritus, shivering, respiratory depression, or any other complication will be recorded.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Premixed', 'Sequential', 'Manually Mixed', 'Intrathecal', 'Fentanyl', 'Bupivacaine', 'Cesarean Section']}, 'descriptionModule': {'briefSummary': 'This study aims to distinguish between premixed, sequential, and manually mixed administration of intrathecal fentanyl and bupivacaine in cesarean section.', 'detailedDescription': 'Cesarean section (CS) is a lifesaving procedure when there is both maternal and fetal problems. The rate of CS increases dramatically from time to time. Regional anesthesia techniques are highly preferred for CS compared to general anesthesia.\n\nCoadministration of intrathecal opioids and local anesthetics (LAs) have been found to produce a potent intra and postoperative analgesic synergism without further depression of efferent sympathetic activity, hence results in less adverse hemodynamic effects, even with sub-therapeutic doses of LAs.\n\nFentanyl has been considered the intrathecal LAs adjuvant of choice owing to its potency, fast onset and short duration of action, and lower incidence of respiratory depression.'}, '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* Height between 150 to175 cm.\n* Body mass index (BMI) between 18.5 and 30 kg/m2.\n* American Society of Anesthesiology (ASA) physical status II.\n* Scheduled for cesarean section under spinal anesthesia.\n\nExclusion Criteria:\n\n* Pre-operation hypotension and bradycardia.\n* Preeclampsia.\n* Multiple pregnancy and macrosomia.\n* Complete or partial failed spinal.\n* Patients with skin infections at the site of injection.\n* Patients with coagulation disorders.\n* Patients with spinal deformities.\n* Patients having regional nerve block other than spinal anesthesia.'}, 'identificationModule': {'nctId': 'NCT06820203', 'briefTitle': 'Premixed, Sequential and Manually Mixed Administration of Intrathecal Fentanyl and Bupivacaine in Cesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Comparison Between Premixed, Sequential and Manually Mixed Administration of Intrathecal Fentanyl and Bupivacaine in Cesarean Section: A Randomized Controlled Study', 'orgStudyIdInfo': {'id': '36264PR1048/1/25'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Premixed group', 'description': 'Patients will receive premixed intrathecal fentanyl and bupivacaine in the same syringe.', 'interventionNames': ['Drug: Fentanyl and Bupivacaine']}, {'type': 'EXPERIMENTAL', 'label': 'Sequential group', 'description': 'Patients will receive intrathecal fentanyl and bupivacaine in separate syringes.', 'interventionNames': ['Drug: Fentanyl and Bupivacaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Manual mixed group', 'description': 'Patients will receive manually mixed intrathecal fentanyl and bupivacaine in the same syringe.', 'interventionNames': ['Drug: Fentanyl and Bupivacaine']}], 'interventions': [{'name': 'Fentanyl and Bupivacaine', 'type': 'DRUG', 'description': 'Patients will receive premixed intrathecal fentanyl and bupivacaine in the same syringe.', 'armGroupLabels': ['Premixed group']}, {'name': 'Fentanyl and Bupivacaine', 'type': 'DRUG', 'description': 'Patients will receive intrathecal fentanyl and bupivacaine in separate syringes.', 'armGroupLabels': ['Sequential group']}, {'name': 'Fentanyl and Bupivacaine', 'type': 'DRUG', 'description': 'Patients will receive manually mixed intrathecal fentanyl and bupivacaine in the same syringe.', 'armGroupLabels': ['Manual mixed group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31527', 'city': 'Tanta', 'state': 'El-Gharbia', 'country': 'Egypt', 'facility': 'Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}]}, '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'}}}}