Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-02-24 @ 10:54 AM
Study NCT ID:
NCT03110120
Status:
COMPLETED
Last Update Posted:
2017-10-10
First Post:
2017-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interest of Serratus Plane Block in Postoperative Analgesia for Robot-assisted Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'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': 'D000772', 'term': 'Anesthesia, Local'}], 'ancestors': [{'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The patient where randomized by the investigator after inform consent was signed The investigator prepared the syringes named "serratus" and "local" with levobupivacaine 0.25 or saline according to randomization The care provider injected the prepared syringes respectively in the serratus plane or locally without knowing their contents The outcome assessor evaluated the post operative pain and the 3 months followup without knowing the randomization'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Compare the efficacy of the serratus plane block with local infiltration after thoracic robot-assisted surgery'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-07', 'studyFirstSubmitDate': '2017-03-08', 'studyFirstSubmitQcDate': '2017-04-11', 'lastUpdatePostDateStruct': {'date': '2017-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'D0 pain intensity', 'timeFrame': '1 day', 'description': 'Self reported pain intensity the day of surgery. Each item is scored 0-100 (0 - no pain, 100 - pain as bad as can be)'}], 'secondaryOutcomes': [{'measure': 'D1 pain intensity', 'timeFrame': '3 days', 'description': 'Self reported pain intensity the days after surgery. Each item is scored 0 - 100 (0 - no pain, 100 - pain as bad as can be)'}, {'measure': 'morphine consumption', 'timeFrame': '5 days', 'description': 'Consumption of morphine the day and 4 days after surgery as recorded on the PCA.'}, {'measure': 'persistence of a chronic pain', 'timeFrame': '3 months', 'description': 'Phone call 3 month after surgery to evaluate the persistence of pain'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Analgesia', 'Robotic Surgery']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to compare the analgesia provided by the serratus plane block with local infiltration of the orifices of the trocars after thoracic robot-assisted surgery.', 'detailedDescription': 'In our hospital, the current practice to provide post operative analgesia for patients scheduled for robot-assisted mitral repair or oncological thoracic surgery is to dispense local anesthetics at the orifices of the trocars at the end of the surgery and to give a Patient Controlled Analgesia (PCA). Some of these patients are not comfortable and we observe a large percentage of chronic pain. Recently we tried to use the Serratus plane block realised before the beginning of the surgery, and it seemed that patients were more comfortable with a lower consumption of morphine. So we decided to perform a double blind, randomized study in this population of patients to compare the analgesia provided by the serratus plane block realized before the beginning of the surgery and the local infiltration of the wound at the end of the surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* mitral repair, coronary artery revascularization or thoracic surgery scheduled robot-assisted surgery\n\nExclusion Criteria:\n\n* non robot-assisted surgery'}, 'identificationModule': {'nctId': 'NCT03110120', 'briefTitle': 'Interest of Serratus Plane Block in Postoperative Analgesia for Robot-assisted Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}, 'officialTitle': 'Interest of Serratus Plane Block in Postoperative Analgesia for Patients Undergoing Robot-assisted Mitral Valve Repair, MIDCAB or Partial Lung Resection', 'orgStudyIdInfo': {'id': '2015/07JAN/008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'serratus', 'description': 'Serratus plane block and local control', 'interventionNames': ['Drug: 0.5% levobupivacaine injectable solution with 10 ml of physiological saline', 'Drug: 0.5% levobupivacaine injectable solution with physiological saline']}, {'type': 'SHAM_COMPARATOR', 'label': 'local', 'description': 'serratus control and local anesthesia', 'interventionNames': ['Drug: 0.5% levobupivacaine injectable solution with 10 ml of physiological saline', 'Drug: 0.5% levobupivacaine injectable solution with physiological saline']}], 'interventions': [{'name': '0.5% levobupivacaine injectable solution with 10 ml of physiological saline', 'type': 'DRUG', 'otherNames': ['serratus plane block'], 'description': 'Serratus plane block realized with a mixture of 10 ml of 0.5% levobupivacaine injectable solution with 10 ml of physiological saline', 'armGroupLabels': ['serratus']}, {'name': '0.5% levobupivacaine injectable solution with 10 ml of physiological saline', 'type': 'DRUG', 'otherNames': ['local anesthesia'], 'description': 'local infiltration of the wound with a mixture of 10 ml of 0.5% levobupivacaine injectable solution with 10 ml of physiological saline', 'armGroupLabels': ['local']}, {'name': '0.5% levobupivacaine injectable solution with physiological saline', 'type': 'DRUG', 'otherNames': ['local serratus'], 'description': 'Serratus plane block realized with 20 ml of injectable solution of physiological saline', 'armGroupLabels': ['local']}, {'name': '0.5% levobupivacaine injectable solution with physiological saline', 'type': 'DRUG', 'otherNames': ['local control'], 'description': 'local infiltration of the wound with 20 ml of injectable solution of physiological saline', 'armGroupLabels': ['serratus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1200', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Watremez Christine', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Christine Watremez, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}