Ignite Creation Date:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2025-12-29 @ 3:22 PM
Study NCT ID:
NCT05242328
Status:
UNKNOWN
Last Update Posted:
2023-02-27
First Post:
2022-01-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Analgesia y After Uniportal Video-assisted Thoracoscopic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D013896', 'term': 'Thoracic Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'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'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2024-12-26', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-23', 'studyFirstSubmitDate': '2022-01-26', 'studyFirstSubmitQcDate': '2022-02-15', 'lastUpdatePostDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual analogue scale', 'timeFrame': 'post-op 2 days', 'description': 'post-op VAS score, 0-10, the higher means painful, and "0" point no pain.'}, {'measure': 'accumulated morphine usage dose', 'timeFrame': 'post-op 2 days', 'description': 'accumulated morphine usage dose'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Uniportal video-assisted thoracoscopic surgery', 'Ultrasound-guided erector spinae plane block', 'surgical thoracoscopic intercostal nerve block', 'cumulative intravenous morphine consumption', 'visual analogue scale', 'Enhanced Recovery After Surgery'], 'conditions': ['Post-operative Pain, Acute', 'Post-operative Pain', 'Thoracic Diseases', 'Post-Op Complication']}, 'descriptionModule': {'briefSummary': 'Ultrasound-guided erector spinae plane block (ESPB) is an interfascial blockade during thoracic anesthesia, first described by Forero in 2016, and is highlighted by technically feasibility and less complication rate. The patient is placed as decubitus position. The anesthesiologists use echo to identify the ipsilateral transverse process at T5 level, and insert the needle to 2-3 cm lateral to the spinous process until contact the transverse process. Then the injected local anesthetic will penetrate via erector spinae muscle to paravertebral space to affect and relieve pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients, over 20 years old, u\n* undergoing elective uniportal VATS lobectomy.\n\nExclusion Criteria:\n\n* patient refusal,\n* body mass index \\> 35 kg/m2,\n* American society of anesthesiologists (ASA) grade above 3,\n* contraindication to nerve block,\n* allergy to analgesic agents,\n* regular opioid used for chronic pain prior to this time surgery,\n* conversion to thoracotomy or VATS procedure,\n* postoperative intubation,\n* postoperative intensive care unit admission.'}, 'identificationModule': {'nctId': 'NCT05242328', 'briefTitle': 'Postoperative Analgesia y After Uniportal Video-assisted Thoracoscopic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'National Cheng-Kung University Hospital'}, 'officialTitle': 'Comparison of Surgical Thoracoscopic Intercostal Nerve Block and Ultrasound-guided Erector Spinae Plane Block for Postoperative Analgesia and Enhanced Recovery After Uniportal Video-assisted Thoracoscopic Surgery: a Double-blinded, Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'A-ER-110-293'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'post-operative VAS score of Ultrasound-guided erector spinae plane block', 'interventionNames': ['Procedure: Ultrasound-guided erector spinae plane block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'post-operative VAS score of surgical thoracoscopic intercostal nerve block', 'interventionNames': ['Procedure: surgical thoracoscopic intercostal nerve block']}], 'interventions': [{'name': 'Ultrasound-guided erector spinae plane block', 'type': 'PROCEDURE', 'description': 'Ultrasound-guided erector spinae plane block', 'armGroupLabels': ['post-operative VAS score of Ultrasound-guided erector spinae plane block']}, {'name': 'surgical thoracoscopic intercostal nerve block', 'type': 'PROCEDURE', 'description': 'surgical thoracoscopic intercostal nerve block', 'armGroupLabels': ['post-operative VAS score of surgical thoracoscopic intercostal nerve block']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tainan', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Shuoying Dai, MD', 'role': 'CONTACT', 'email': 'hsnu_10@yahoo.com.te', 'phone': '+886-6-2353535', 'phoneExt': '5182'}], 'facility': 'National Cheng Kung University Hospital', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}], 'centralContacts': [{'name': 'Shuoying Dai, MD', 'role': 'CONTACT', 'email': 'hsnu_10@yahoo.com.tw', 'phone': '+886-6-2353535', 'phoneExt': '5182'}], 'overallOfficials': [{'name': 'Shuoying Dai', 'role': 'STUDY_CHAIR', 'affiliation': 'National Cheng-Kung University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cheng-Kung University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}