Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2026-02-21 @ 4:08 PM
Study NCT ID:
NCT03777592
Status:
UNKNOWN
Last Update Posted:
2019-02-28
First Post:
2018-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perioperative Erector Spinae Plane Block in Thoracoscopic Surgery
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 54}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2020-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-26', 'studyFirstSubmitDate': '2018-12-12', 'studyFirstSubmitQcDate': '2018-12-13', 'lastUpdatePostDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain scale', 'timeFrame': 'the first 5 min after arriving at the recovery room', 'description': '11-point numeric rating scale(\n\n(Scores from 0 to 10 are scored. The higher the score, the higher the degree of pain.The score is given in units of one point.)'}, {'measure': 'Pain scale', 'timeFrame': '20 min after arriving at the recovery room', 'description': '11-point numeric rating scale (Scores from 0 to 10 are scored. The higher the score, the higher the degree of pain.The score is given in units of one point.)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain, Postoperative', 'Regional Block']}, 'descriptionModule': {'briefSummary': 'The erector spinae plane block (ESPB) is a novel myofascial plane block. The ESPB is targeted at anterior surface of the erector spinae plane, which is oriented cephalocaudally to the spinal transverse process. Local anaesthetic injected in this plane can block the dorsal rami and ventral rami and intercostal nerves. The aim of this study was to evaluate the effect of ESPB on postoperative pain in thoracic surgery.', 'detailedDescription': 'The erector spinae plane block (ESPB) is a newly defined regional anesthesia technique for thoracic analgesia. The blocks were performed at the T5 level of the spine using an in-plane approach.Previous studies were not designed as randomized controlled trial. In this study, the efficacy of ESPB is to confirm with randomized controlled trial design. ESPB will be performed in video assisted thoracoscopy preoperatively. After the surgery, the efficacy of ESPB will be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists Patients with physical class 1, 2\n* Patients undergoing video assisted thoracoscopic surgery\n\nExclusion Criteria:\n\n* Patients who experienced side effects on local anesthetics\n* Patients with abnormal blood coagulation tests (INR\\> 1.5)\n* Pregnant or lactating patients'}, 'identificationModule': {'nctId': 'NCT03777592', 'briefTitle': 'Perioperative Erector Spinae Plane Block in Thoracoscopic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Kangbuk Samsung Hospital'}, 'officialTitle': 'Correlation Between Perioperative Erector Spinae Plane Block and Postoperative Pain in Thoracoscopic Surgery', 'orgStudyIdInfo': {'id': '2018-09-017-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ESPB with local agent', 'description': 'ESPB will be performed using 20ml of 0.5% ropivacaine.', 'interventionNames': ['Procedure: erector spinae plane block']}, {'type': 'SHAM_COMPARATOR', 'label': 'ESPB with saline', 'description': 'ESPB will be performed using 20ml of saline.', 'interventionNames': ['Procedure: erector spinae plane block']}], 'interventions': [{'name': 'erector spinae plane block', 'type': 'PROCEDURE', 'description': 'local anesthetic or saline is administered in to the interfascial plane between the transverse process of the vertebra and the erector spinae muscles, spreading to multiple paravertebral spaces', 'armGroupLabels': ['ESPB with local agent', 'ESPB with saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03181', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sung Hyun Lee, MD', 'role': 'CONTACT'}], 'facility': 'KangbukSamsung Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Sung Hyun Lee, MD', 'role': 'CONTACT', 'email': '4321hoho@naver.com', 'phone': '82-2-2001-2323'}, {'name': 'Kyoung-Ho Ryu, MD', 'role': 'CONTACT', 'email': 'drkhryu@gmail.com', 'phone': '82-2-2001-1376'}], 'overallOfficials': [{'name': 'Sung Hyun Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kangbuk Samsung Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kangbuk Samsung Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Sung Hyun Lee', 'investigatorAffiliation': 'Kangbuk Samsung Hospital'}}}}