Ignite Creation Date:
2025-12-24 @ 2:07 PM
Ignite Modification Date:
2026-02-20 @ 3:47 PM
Study NCT ID:
NCT03867695
Status:
UNKNOWN
Last Update Posted:
2019-06-04
First Post:
2019-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SERRATHOR TRIAL : Interest of the Novel Serratus Plane Block in Post Operative Analgesia After Video-Assisted Thoracoscopic Lobectomy
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077212', 'term': 'Ropivacaine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2020-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-06-03', 'studyFirstSubmitDate': '2019-03-01', 'studyFirstSubmitQcDate': '2019-03-05', 'lastUpdatePostDateStruct': {'date': '2019-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total intravenous morphine consumption (mg) in the PACU and department.', 'timeFrame': '24 hours', 'description': 'Including the dose of titration while the patient is in PACU and PCA up to 24h postoperatively.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Serratus plane block', 'Analgesia after VATS', 'Lobectomy VATS'], 'conditions': ['Video Assisted Thoracoscopic Surgery', 'Lobectomy', 'Pain Post Operative', 'Regional Anesthesia']}, 'descriptionModule': {'briefSummary': 'Pain after thoracic surgery remains a challenge for anesthetists. Although VATS for lobectomy is associated with fewer complications compared to thoracotomy, pain after VATS needs to be treated with opioids. Opioids may lead to PONV, respiratory depression, sedation and pruritus. As part of multimodal analgesia and opioids sparing, several local regional techniques has been described: paravertebral block, thoracic epidural analgesia, intercostal block. To date, there is no gold standard for regional anesthesia after VATS.\n\nSerratus plane block is a local regional technique, recently described for analgesia after breast surgery and ribs fracture. In our hospital center, since 2016, we used the Serratus plane block for patients scheduled for lobectomy VATS : a local retrospective trial showed that SPB was associated with a lower consumption of morphine.\n\nThe purpose of this randomized controlled double blinded study is to evaluate the analgesic effect of the Serratus plane block, added to a general anesthesia on post operative pain control after VATS lobectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* All patients undergoing lobectomy VATS\n* Older \\> 18 years\n* Patients who meet criteria of ASA 1 to 3 class\n\nExclusion criteria:\n\n* Patient's refusal to participate in the study\n* Psychiatric disorder (impossibility to collect the informed consent)\n* Patient under juridical protection\n* On going an other study\n* Non balanced epilepsy\n* 3 grade auriculo-ventricular heart block without pacing\n* Severe hepatocellular insufficiency\n* Anti arrhythmic treatment : class III of the Vaughan William's classification\n* Pregnant patient or/and breastfeeding\n* History of opioid abuse\n* Allergy to local anesthetic drug or opioids"}, 'identificationModule': {'nctId': 'NCT03867695', 'acronym': 'SERRATHOR', 'briefTitle': 'SERRATHOR TRIAL : Interest of the Novel Serratus Plane Block in Post Operative Analgesia After Video-Assisted Thoracoscopic Lobectomy', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'SERRATHOR Trial : Analgesic Effect of Serratus Plane Block After Video-Assisted Thoracoscopic Surgery Lobectomy', 'orgStudyIdInfo': {'id': '6755'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Serratus Block', 'description': 'At the end of the lobectomy VATS procedure, 0,5 mL/kg of 0.375% ropivacaine will be administered.\n\nUnder ultrasonography assistance, block will be performed at the fifth rib in the midaxillary line. Local anesthetic will be injected either superficial to the serratus anterior muscle or deep underneath the muscle.\n\nAnesthesiologists, and all the nurses and caring staff involved in this study will be blinded. Solutions of ropivacaine will be prepared identically by the central pharmacy, without any possible identification of the product.', 'interventionNames': ['Drug: Ropivacaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Block - Control Group', 'description': 'Patients will receive a placebo injection with 0,5 mL/kg of sterile normal solution. Under ultrasonography assistance, placebo will be injected at the fifth rib in the midaxillary line, either superficial to the serratus anterior muscle or deep underneath the muscle.\n\nAnesthesiologists, and all the nurses and caring staff involved in this study will be blinded. Solutions of sterile saline will be prepared identically by the central pharmacy, without any possible identification of the product.', 'interventionNames': ['Drug: sterile saline']}], 'interventions': [{'name': 'Ropivacaine', 'type': 'DRUG', 'description': 'At the end of the lobectomy VATS procedure, 0,5 mL/kg of 0.375% ropivacaine will be administered.', 'armGroupLabels': ['Serratus Block']}, {'name': 'sterile saline', 'type': 'DRUG', 'description': 'Patients will receive a placebo injection with 0,5 mL/kg of sterile normal solution', 'armGroupLabels': ['Placebo Block - Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'country': 'France', 'contacts': [{'name': 'Bob HEGER', 'role': 'CONTACT', 'email': 'Bob.Heger@chru-strasbourg.fr', 'phone': '+33 3.69.55.04.43'}, {'name': 'Bob HEGER', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Gharib AJOB', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Annick STEIB', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Paul-Michel MERTES', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Olivier HELMS', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Fayçal EL MILOUDI', 'role': 'SUB_INVESTIGATOR'}, {'name': 'François FISCHER', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Cécile GROS', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Francois LEVY', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Pierre-Emmanuel FALCOZ', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Nicolas SANTELMO', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Les Hôpitaux Universitaires de Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Bob HEGER', 'role': 'CONTACT', 'email': 'Bob.Heger@chru-strasbourg.fr', 'phone': '+33 3.69.55.04.43'}, {'name': 'Gharib AJOB', 'role': 'CONTACT', 'email': 'Gharib.ajob@chru-strasbourg.fr', 'phone': '+33 3.69.55.07.92'}], 'overallOfficials': [{'name': 'Bob HEGER', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Les Hôpitaux Universitaires de Strasbourg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}