Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-31 @ 2:02 AM
Study NCT ID:
NCT07478692
Status:
COMPLETED
Last Update Posted:
2026-03-17
First Post:
2026-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Transversus Abdominis Plane Block on Recovery Quality and Maternal-Neonatal Outcomes After Cesarean Delivery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 83}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2025-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-13', 'studyFirstSubmitDate': '2026-03-07', 'studyFirstSubmitQcDate': '2026-03-13', 'lastUpdatePostDateStruct': {'date': '2026-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VAS pain scores (0-10 scale, where 0 = no pain and 10 = unbearable severe pain) at rest and during activity ( Time to first rescue analgesia requirement and number of patients and total dosage of flurbiprofen axetil used within 48 hours postoperatively;', 'timeFrame': '5 months', 'description': 'VAS pain scores (0-10 scale, where 0 = no pain and 10 = unbearable severe pain) at rest and during activity (coughing or turning) at 2, 6, 12, 24, and 48 hours postoperatively were recorded by anesthesiologists not involved in this study.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Pain After Cesarean Section']}, 'descriptionModule': {'briefSummary': 'ltrasound-guided transversus abdominis plane (TAP) block is an emerging local anesthesia technique that effectively alleviates postoperative pain by injecting anesthetic drugs around the nerves in the abdominal wall. Compared with traditional analgesic methods, TAP blockade may have better analgesic effects and fewer side effects. However, current research on the application of TAP blockade after cesarean section is still limited. Therefore, this study will systematically evaluate its actual effectiveness in pain management after cesarean section through a prospective randomized controlled trial'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 20-40 years, in good general health\n* ASA physical status I-II\n* Singleton, term (37-41 weeks) pregnancy with normal fetal development\n* Planned for elective cesarean section, no labor\n\nExclusion Criteria:\n\n* Pregnancy complications (e.g., severe preeclampsia, gestational diabetes, placental abruption)\n* Major organ dysfunction (heart, liver, kidney) or psychiatric history\n* Allergy to local anesthetics or any study drugs\n* Prior abdominal surgery or infection that may affect block efficacy\n* Coagulation disorders or current anticoagulant use\n* Refusal to participate or inability to comply with follow-up'}, 'identificationModule': {'nctId': 'NCT07478692', 'briefTitle': 'Effects of Transversus Abdominis Plane Block on Recovery Quality and Maternal-Neonatal Outcomes After Cesarean Delivery', 'organization': {'class': 'OTHER', 'fullName': 'Shandong Provincial Maternal and Child Health Care Hospital Affiliated to Qingdao University'}, 'officialTitle': 'Effects of Transversus Abdominis Plane Block on Recovery Quality and Maternal-Neonatal Outcomes After Cesarean Delivery', 'orgStudyIdInfo': {'id': '202318001040'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TAP Block Group', 'description': 'The TAP block group received ultrasound-guided bilateral TAP block (20 mL of 0.375 % ropivacaine per side) during surgery and postoperative intravenous analgesia pump (formula of butorphanol 2 mg/kg + tropisetron 8 mg);', 'interventionNames': ['Drug: The TAP block group received ultrasound-guided bilateral TAP block (20 mL of 0.375 % ropivacaine per side) during surgery and postoperative intravenous analgesia pump (formula of butorphanol 2 mg/kg)']}, {'type': 'NO_INTERVENTION', 'label': 'the control group', 'description': 'received only the same formula intravenous analgesia pump. For both groups, rescue'}], 'interventions': [{'name': 'The TAP block group received ultrasound-guided bilateral TAP block (20 mL of 0.375 % ropivacaine per side) during surgery and postoperative intravenous analgesia pump (formula of butorphanol 2 mg/kg)', 'type': 'DRUG', 'description': 'the control group received only the same formula intravenous analgesia pump', 'armGroupLabels': ['TAP Block Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250014', 'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'facility': 'Shandong Provincial Maternal and Child Health Care Hospital', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'facility': 'Shandong Provincial Maternal and Child Health Care Hospital', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qing Yuan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Shandong Provincial Maternal and Child Health Care Hospital', 'investigatorFullName': 'Qing Yuan', 'investigatorAffiliation': 'Shandong Provincial Maternal and Child Health Care Hospital Affiliated to Qingdao University'}}}}