Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT05826093
Status:
COMPLETED
Last Update Posted:
2025-08-22
First Post:
2023-04-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cutaneous Sensory Block Area of the Subcostal Ultrasound-Guided Transversus Abdominis Plane Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-10-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-18', 'studyFirstSubmitDate': '2023-04-03', 'studyFirstSubmitQcDate': '2023-04-11', 'lastUpdatePostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cutaneous Sensory Block Area', 'timeFrame': '90 minutes postoperatively or 150 minutes after US-TAP application', 'description': 'The area of the dermis which is blocked to sensory stimulus such as pain, heat and cold.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Transversus abdominis plane block'], 'conditions': ['Postoperative Pain']}, 'referencesModule': {'references': [{'pmid': '37640451', 'type': 'BACKGROUND', 'citation': 'Salmonsen CB, Lange KHW, Rothe C, Kleif J, Bertelsen CA. Cutaneous sensory block area of the ultrasound-guided subcostal transversus abdominis plane block: an observational study. Reg Anesth Pain Med. 2024 Apr 2;49(4):289-292. doi: 10.1136/rapm-2023-104753.'}]}, 'descriptionModule': {'briefSummary': 'Patients planned for elective laparoscopic cholecystectomy received a peroperative ultrasound-guided subcostal transversus abdominis plane block (USTAP) at the beginning of the procedure. At T90 minutes after the end of anaesthesia the cutaneous sensory block area (CSBA) was measured using cold sensation and mapped with a sterile marker. The CSBA was photodocumented and the area calculated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients planned for elective laparoscopic cholecystectomy in a day surgery setting.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Planned for elective laparoscopic cholecystectomy, age 18 or older, written and verbal consent\n\nExclusion Criteria:\n\n* Non-compliant due to language or psychiatric disease, previous surgery to the upper abdomen, incisional hernia, pregnancy, sensory deficit of the abdomen or thorax.'}, 'identificationModule': {'nctId': 'NCT05826093', 'acronym': 'CUSBAT', 'briefTitle': 'Cutaneous Sensory Block Area of the Subcostal Ultrasound-Guided Transversus Abdominis Plane Block', 'organization': {'class': 'OTHER', 'fullName': 'Nordsjaellands Hospital'}, 'officialTitle': 'Cutaneous Sensory Block Area of the Subcostal Ultrasound-Guided Transversus Abdominis Plane Block', 'orgStudyIdInfo': {'id': 'CSBA-SUSTAP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients planned for cholecystectomy', 'description': 'Patients planned for elective laparoscopic cholecystectomy received a peroperative ultrasound-guided transversus abdominis plane (TAP) block at the beginning of the procedure.', 'interventionNames': ['Procedure: Ultrasound-guided subcostal transversus abdominis plane block (US-TAP)']}], 'interventions': [{'name': 'Ultrasound-guided subcostal transversus abdominis plane block (US-TAP)', 'type': 'PROCEDURE', 'description': 'US-TAP is a peripheral nerve block applied for postoperative pain relief. Subcostal refers to the approach which can also be lateral or posterior. In this trial the subcostal approach was used.', 'armGroupLabels': ['Patients planned for cholecystectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3400', 'city': 'Hillerød', 'country': 'Denmark', 'facility': 'Nordsjaellands Hospital', 'geoPoint': {'lat': 55.92791, 'lon': 12.30081}}], 'overallOfficials': [{'name': 'Cluas A Bertelsen, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Copenhagen University Hospital - North Zealand'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nordsjaellands Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}