Ignite Creation Date:
2025-12-24 @ 10:03 PM
Ignite Modification Date:
2025-12-28 @ 11:46 PM
Study NCT ID:
NCT04538235
Status:
COMPLETED
Last Update Posted:
2020-09-04
First Post:
2020-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analgesic Non Inferiority of the Thoracic Bi-block in Comparison With Thoracic Epidural for VATS.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D010995', 'term': 'Pleural Diseases'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013662', 'term': 'Tea'}], 'ancestors': [{'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-03', 'studyFirstSubmitDate': '2020-09-02', 'studyFirstSubmitQcDate': '2020-09-03', 'lastUpdatePostDateStruct': {'date': '2020-09-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cumulative morphine consumption on postoperative day 2', 'timeFrame': 'postoperative day 2', 'description': 'cumulative morphine consumption on postoperative day 2, including the morphine administered in Post anesthesia care unit (PACU), on postoperative day 0, 1 and 2.'}], 'secondaryOutcomes': [{'measure': 'non-opioid analgesics consumption on postoperative day 2', 'timeFrame': 'postoperative day 2', 'description': 'Paracetamol, Tramadol, Ketoprofen, Nefopam cumulative consumption on POD 2.'}, {'measure': 'Pain assessed by visual analog pain scale (VAS)', 'timeFrame': 'up to postoperative day 2', 'description': 'mean VAS, maximal VAS, number of events with a VAS \\> 3'}, {'measure': 'Urinary retention', 'timeFrame': 'up to postoperative day 2'}, {'measure': 'hypotension', 'timeFrame': 'up to postoperative day 2'}, {'measure': 'pleural drain duration', 'timeFrame': 'up to postoperative day 2'}, {'measure': 'duration of hospitalization', 'timeFrame': 'up to postoperative day 2'}, {'measure': 'occurrence of prurit', 'timeFrame': 'up to postoperative day 2'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['regional anesthesia', 'video-assisted thoracic surgery'], 'conditions': ['Erector Spinae Muscle Plane Block', 'Serratus Anterior Muscle Plane Block', 'Video-Assisted Thoracic Surgery', 'Lung Cancer', 'Pleural Diseases', 'Thoracic Epidural', 'Analgesia', 'Enhanced Recovery After Surgery']}, 'descriptionModule': {'briefSummary': 'Video-Assisted thoracic surgery (VATS) is the standard treatment for localized lung cancer. However, there is no consensus on analgesic management in patients undergoing VATS.\n\nThe aim of the study is to compare the analgesic efficacy of thoracic epidural with that a "Bi-block" combining an Erector Spinae muscle plane Block (ESP) and a Serratus Anterior Block (SAP) in patients undergoing VATS for lung or pleural surgery.\n\nOur main hypothesis is that the analgesic efficacy of the Bi-block, assessed by morphine consumption, is not inferior to that provided by a thoracic epidural during the first 48 hours after VATS. We conducted a age, gender and type of surgery-matched retrospective cohort study in the Department of Thoracic Anesthesia of the Montpellier University Hospital (France).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Each patient enrolled in the Bi-block group were matched by age, gender and type of surgery with two controls in the TEA group. Patients not-matched were secondarily excluded.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* To be over 18.\n* To be scheduled for VATS in the center of the study during the study period.\n* Thoracic Epidural analgesia of Bi-block analgesia.\n\nExclusion Criteria:\n\n* Chronic pain or opioid use before surgery (6 months).\n* Postoperative hospitalization in ICU during the first two days.\n* Postoperative surgical complication needing surgical revision during the first two days.\n* Preoperative dementia or other psychiatric disease incompatible with VAS pain scoring.'}, 'identificationModule': {'nctId': 'NCT04538235', 'acronym': 'ANESSTEVATS', 'briefTitle': 'Analgesic Non Inferiority of the Thoracic Bi-block in Comparison With Thoracic Epidural for VATS.', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Analgesic Non Inferiority of the Thoracic Bi-block Combining an Erector Spinae Muscle Plane Block and a Serratus Anterior Muscle Plane Block in Comparison With Thoracic Epidural for Video-Assisted Thoracic Surgery.', 'orgStudyIdInfo': {'id': 'RECHMPL19_0473'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Bi-block (Serratus and erector spinae block) group', 'description': 'The Bi-block consisted in performing an ESP block followed by a SAP block on the side ipsilateral to the thoracic surgery. For the ESP block, 40 ml of Ropivacaine 2mg/ml were injected under the erector spinae muscle plane, at the level of the 4th thoracic vertebra. For the SAP block, 40 ml of Ropivacaine 2 mg/ml were injected under the serratus anterior muscle plane. The cumulative dose of Ropivacaine did not exceed 3 mg/kg.\n\nRegional anesthesia was performed before surgery.', 'interventionNames': ['Procedure: Thoracic Regional Analgesia']}, {'label': 'Thoracic Epidural Analgesia (TEA) group', 'description': "The thoracic epidural was performed according to a standardized protocol, with a Tuohy needle via the median puncture technique, at the level of T4-T5 intervertebral space. After a test dose of 2 to 3 ml of Lidocaine, 5 to 10 ml of a mixture of Ropivacaine 2 mg/ml and Sufentanil 0.5 µg / mL were injected. Epidural continuous administration was performed with the same mixture of anesthetic connected to a CADD Solis ™ pump set according to a PCEA protocol adapted to the patient's weight (continuous flow rate from 3 to 6 ml/h, self-administered bolus dose from 3 to 5 ml, refractory period 30 min).\n\nRegional anesthesia was performed before surgery.", 'interventionNames': ['Procedure: Thoracic Regional Analgesia']}], 'interventions': [{'name': 'Thoracic Regional Analgesia', 'type': 'PROCEDURE', 'otherNames': ['Thoracic Epidural Analgesia', 'Bi-block, a regional anesthesia technique combining a serratus anterior block with an erector spinae block'], 'description': 'In the TEA group, a thoracic epidural was performed before VATS. In the Bi-block group, a SAP block associated with an ESP block were performed before surgical incision under general anesthesia.', 'armGroupLabels': ['Bi-block (Serratus and erector spinae block) group', 'Thoracic Epidural Analgesia (TEA) group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Intensive Care Unit, D - University hospital of Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Pierre Sentenac, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Montpellier University Hospital'}, {'name': 'Pascal H Colson, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Montpellier University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}