Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2025-12-30 @ 4:56 AM
Study NCT ID:
NCT04874168
Status:
UNKNOWN
Last Update Posted:
2022-02-15
First Post:
2021-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of Transversus Abdominis Plane Block Versus Wound Infiltration for Analgesia After Cesarean Delivery:
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'computer-generated table of random numbers'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 210}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-14', 'studyFirstSubmitDate': '2021-04-25', 'studyFirstSubmitQcDate': '2021-05-01', 'lastUpdatePostDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The degree of pain on movement (hip flexion and coughing)', 'timeFrame': 'From 2 hours to 24 hours postoperatively', 'description': 'using an Visual analogue scale (VAS) scores for pain intensity reported on 0-10 point scale for analysis. (0 = no pain and 10 = the worst possible pain) .'}], 'primaryOutcomes': [{'measure': 'The degree of pain at rest ;', 'timeFrame': 'From 2 hours to 24 hours postoperatively', 'description': 'using an Visual analogue scale (VAS) scores for pain intensity reported on 0-10 point scale for analysis. (0 = no pain and 10 = the worst possible pain) .'}], 'secondaryOutcomes': [{'measure': 'The time to the first postoperative opioid dose', 'timeFrame': 'at 2, 4, 6, and 12 hours.', 'description': 'cumulative opioid consumption'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cesarean Section Complications']}, 'descriptionModule': {'briefSummary': 'This study aimed to compare bilateral ultrasound-guided TAP block with single-shot local anesthetic wound infiltration for analgesia after cesarean delivery performed under spinal anesthesia', 'detailedDescription': 'This double-blind, randomized controlled trial aimed to compare bilateral ultrasound-guided TAP block to single-shot local anesthetic wound infiltration for analgesia after cesarean delivery performed under spinal anesthesia. This will be done by measuring VAS (visual analogue score) for pain after ceserian section at2, 4, 6, 12, 24 hours .'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '19 Years', 'genderBased': True, 'genderDescription': 'Women undergoing cesarean section under spinal anesthesia .', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women undergoing cesarean section under spinal anesthesia\n* Aged ≥19 years and \\> 40 years .\n* Gestational age ≥ 37 Weeks .\n* Informed Consent From the Patient .\n\nExclusion Criteria:\n\n* Body mass index (BMI) ≥40 kg/m2 ..\n* History of recent opioid exposure .\n* Hypersensitivity to any of the drugs used in the study .\n* Significant cardiovascular, renal, or hepatic disease.'}, 'identificationModule': {'nctId': 'NCT04874168', 'acronym': 'TAPBLOCK', 'briefTitle': 'The Efficacy of Transversus Abdominis Plane Block Versus Wound Infiltration for Analgesia After Cesarean Delivery:', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'The Efficacy of Transversus Abdominis Plane Block Versus Wound Infiltration for Analgesia After Cesarean Delivery: (A Randomized Controlled Double-blinded Clinical Trial )', 'orgStudyIdInfo': {'id': 'tapblockvwoundInfiltration'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'In the TAP group (Group A )', 'description': 'after completion of surgery, bilateral ultrasound-guided TAP block was performed .\n\nDescription of the intervention: a 12-4-MHz linear array transducer (ClearVue 350; Philips, Bothell, WA) placed transversely between the iliac crest and costal margin in the anterior axillary line and slid medial-lateral to visualize the external oblique, internal oblique, and trans-versus abdominis muscles; the most lateral (posterior) position obtaining a satisfactory ultrasound image was used ;A 22-gauge spinal needle was introduced from medial to lateral in-plane to the ultrasound probe, and 20 mL of bupivacaine 0.25% was injected under visualization in the plane between the transversus abdominis muscle and the fascia deep to the internal oblique muscle on each side.', 'interventionNames': ['Device: TAP block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'In the infiltration group (Group B )', 'description': 'at the end of surgery, 40 mL of bupivacaine 0.25% was injected subcutaneously in the surgical wound (20 mL in each of the upper and lower sides) by the obstetrician before skin closure.', 'interventionNames': ['Device: TAP block']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'In placebo group (Group C )', 'description': 'routine analgesic was administered and recorded .', 'interventionNames': ['Device: TAP block']}], 'interventions': [{'name': 'TAP block', 'type': 'DEVICE', 'otherNames': ['wound infiltration'], 'description': 'bilateral ultrasound-guided TAP block was performed using a 12-4-MHz linear array transducer (ClearVue 350; Philips, Bothell, WA) placed transversely between the iliac crest and costal margin in the anterior axillary line and slid medial-lateral to visualize the external oblique, internal oblique, and trans-versus abdominis muscles; the most lateral (posterior) position obtaining a satisfactory ultrasound image was used', 'armGroupLabels': ['In placebo group (Group C )', 'In the TAP group (Group A )', 'In the infiltration group (Group B )']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'state': 'Alabbasia', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'ahmed G elnajar, md', 'role': 'CONTACT', 'email': 'a7medgamal2020.ag@gmail.com', 'phone': '0201092672757'}], 'facility': 'Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Ahmed Gamal Elnajar, MD', 'role': 'CONTACT', 'email': 'a7medgamal2020.ag@gmail.com', 'phone': '0201092672757'}], 'overallOfficials': [{'name': 'Ahmed G Elnajar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ain Shams University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical professor', 'investigatorFullName': 'Mohamed Hassan Mohamed Mostafa', 'investigatorAffiliation': 'Ain Shams University'}}}}