Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-02-18 @ 12:36 PM
Study NCT ID:
NCT02292667
Status:
UNKNOWN
Last Update Posted:
2016-08-12
First Post:
2014-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of the Ultrasound-guided Transversus Abdominis Plane Block in Open Aortic Abdominal Aneurysm Repair Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017544', 'term': 'Aortic Aneurysm, Abdominal'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D001014', 'term': 'Aortic Aneurysm'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001018', 'term': 'Aortic Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010323', 'term': 'Passive Cutaneous Anaphylaxis'}, {'id': 'D016058', 'term': 'Analgesia, Patient-Controlled'}, {'id': 'D000082', 'term': 'Acetaminophen'}], 'ancestors': [{'id': 'D012882', 'term': 'Skin Tests'}, {'id': 'D007159', 'term': 'Immunologic Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D000937', 'term': 'Antigen-Antibody Reactions'}, {'id': 'D055633', 'term': 'Immune System Phenomena'}, {'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-08-11', 'studyFirstSubmitDate': '2014-11-05', 'studyFirstSubmitQcDate': '2014-11-13', 'lastUpdatePostDateStruct': {'date': '2016-08-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Morphine consumption during the first postoperative 24 hours', 'timeFrame': '24 hours', 'description': 'The morphine consumption during the first postoperative 24 hours is the total dose of morphine delivered both by the patient-controlled analgesia device and during the titration of morphine by the nurse in the post-anesthesia care unit.'}], 'secondaryOutcomes': [{'measure': 'Delay between the last peroperative injection of opioid and the first administration of morphine in the post-anesthesia care unit', 'timeFrame': '24 hours'}, {'measure': 'Morphine consumption during the first postoperative 48 hours', 'timeFrame': '48 hours', 'description': 'The morphine consumption during the first postoperative 48 hours is the total dose of morphine delivered both by the patient-controlled analgesia device and during the titration of morphine by the nurse in the post-anesthesia care unit.'}, {'measure': 'Pain intensity at rest assessed by the visual analog scale for pain', 'timeFrame': '48 hours'}, {'measure': 'Pain intensity at mobilisation assessed by the visual analog scale for pain', 'timeFrame': '48 hours'}, {'measure': 'Percentage of patients suffering from insomnia during the first and/or the second postoperative night', 'timeFrame': '48 hours'}, {'measure': 'Percentage of patients suffering from awakenings during the first and/or the second postoperative night', 'timeFrame': '48 hours'}, {'measure': 'Incidence of morphine side effects', 'timeFrame': '48 hours', 'description': 'Morphine side effects include: nausea, vomiting, pruritus, drowsiness, respiratory depression'}, {'measure': 'Incidence of TAP block side effects', 'timeFrame': '48 hours', 'description': 'TAP block side effects are any side effect occuring in the ETAP group and considered to be related to the TAP block by the safety board of the study.'}, {'measure': 'Ropivacaine sides effects', 'timeFrame': '48 hours', 'description': 'Ropivacaine sides effects are: cardiac toxicity, neurologic toxicity, allergy'}, {'measure': 'Post-operative morbidity', 'timeFrame': 'Day 30', 'description': 'Any of the following events occuring within the 30 first post-operative days: myocardial infarction, acute congestive heart failure, ventricular tachycardia, ventricular fibrillation, atelectasis, pneumonia, acute respiratory failure requiring invasive or non invasive mechanical ventilation, acute kidney failure, non infectious systemic inflammatory response syndrome, sepsis, surgical wound complication.'}, {'measure': '30-day survival', 'timeFrame': 'Day 30'}, {'measure': 'Duration of hospital stay', 'timeFrame': 'Expected average of 10 days', 'description': 'Patients will be followed for the duration of hospital stay, an expected average of 10 days.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Transversus Abdominis Plane Block', 'Postoperative Pain Management', 'Open Repair of Aortic Abdominal Aneurysm'], 'conditions': ['Aortic Aneurysm, Abdominal', 'Pain', 'Anesthesia, Local']}, 'referencesModule': {'references': [{'pmid': '18165577', 'type': 'RESULT', 'citation': 'McDonnell JG, Curley G, Carney J, Benton A, Costello J, Maharaj CH, Laffey JG. The analgesic efficacy of transversus abdominis plane block after cesarean delivery: a randomized controlled trial. Anesth Analg. 2008 Jan;106(1):186-91, table of contents. doi: 10.1213/01.ane.0000290294.64090.f3.'}]}, 'descriptionModule': {'briefSummary': 'The ETAP study aim to assess the effect of the addition of an ultrasound-guided transversus abdominis plane (TAP) block to a multimodal intravenous analgesia protocol on the postoperative pain control in open surgical repair of abdominal aortic aneurysm. The ETAP study is a single-center open-label randomized controlled trial. Half of patients included will receive the association of TAP block and multimodal intravenous analgesia, and the other half will receive the multimodal intravenous analgesia alone. The multimodal intravenous analgesia includes intravenous paracetamol and intravenous patient-controlled analgesia with morphine.', 'detailedDescription': 'The open repair of abdominal aortic aneurysm (AAA) is a painful surgery. Patients suffering from AAA are at high risk of perioperative cardiovascular and pulmonary complications. It has been previously suggested that a bad perioperative pain control could increase the incidence of such complications.\n\nIntravenous patient-controlled analgesia (PCA) with morphine is widely considered as the gold standard treatment of the postoperative pain in open repair of AAA. High dose of morphine are often required and could delay the postoperative recovery and discharge. Side effects of morphine, such as respiratory depression, nausea, vomiting or pruritus, are responsible for patient discomfort and dissatisfaction when high doses are used.\n\nThe efficacy of the ultrasound-guided transversus abdominis plane (TAP) block has been described for pain management following abdominal surgery, such as gastrectomy or kidney transplantation. The efficacy of the association of TAP block and PCA with morphine was higher than multimodal intravenous analgesia including PCA with morphine and than the combination of PCA with morphine and epidural analgesia. To our knowledge, the efficacy of the ultrasound-guided TAP block has never been studied for the postoperative pain control in AAA surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA (American Society of Anesthesiologists) physical status 1, 2 or 3\n* Elective surgery for open repair of an aortic abdominal aneurysm performed in the Vascular Surgery Unit of the University Hospital of Besancon\n* Informed consent given\n* Health medical insurance affiliation\n\nExclusion Criteria:\n\n* Poor adherence to protocol attended\n* Incapacity to consent\n* Pregnancy and/or breast feeding\n* Endovascular repair of aortic abdominal aneurysm\n* Emergent surgery of a rupture or a fissuration of aortic abdominal aneurysm\n* Chronic medical treatment by clopidogrel if clopidogrel not stopped 5 days before surgery at least\n* Chronic medical treatment by prasugrel if prasugrel not stopped 7 days before surgery at least\n* Chronic medical treatment by ticlopidine, inhibitors of phosphodiesterase , inhibitors of glycoprotein IIb/IIIa, adenosine triphosphate analogs or thrombin receptor antagonists\n* Congenital or acquired bleeding disorder\n* Incapacity to use patient-controlled analgesia device\n* Chronic opioid abuse or dependence\n* Chronic renal failure defined as a clearance \\< 30 ml/min\n* Severe hepatic failure\n* Other contraindications to ropivacaïne (allergy, medical history of porphyria, hypovolemia)\n* Contraindications to acetaminophen\n* Contraindications to morphine'}, 'identificationModule': {'nctId': 'NCT02292667', 'acronym': 'ETAP', 'briefTitle': 'Efficacy of the Ultrasound-guided Transversus Abdominis Plane Block in Open Aortic Abdominal Aneurysm Repair Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Besancon'}, 'officialTitle': 'Efficacy of the Ultrasound-guidedTransversus Abdominis Plane (TAP) Block on Postoperative Pain Control in Open Aortic Abdominal Aneurysm Repair Surgery', 'orgStudyIdInfo': {'id': 'API/2014/52'}, 'secondaryIdInfos': [{'id': '2014-003665-20', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TAP BLOCK', 'description': 'Patients included in the ETAP group will receive the combination of a bilateral ultrasound-guided Transversus Abdominis Plane (TAP) block and a multimodal intravenous analgesia protocol for the postoperative pain management after the surgical open repair of an aortic abdominal aneurysm.\n\nThe TAP block consists in 2 ultrasound-guided injections of Ropivacaine 0.375% on each side of the abdominal wall between the internal oblique and transversus abdominis muscles: 1 subcostal injection and 1 supra-iliac injection (i.e 10 ml of Ropivacaine 0.375% by injection).\n\nThe multimodal intravenous analgesia protocol consists in the association of intravenous infusion of 1 g of Acetaminophen every 6 h and intravenous patient-controlled analgesia (PCA) with Chlorhydrate of Morphine 1 mg/ml.', 'interventionNames': ['Procedure: TAP block', 'Drug: PCA with Chlorhydrate of Morphine', 'Drug: Acetaminophen']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CONTROL', 'description': 'Patients included in the CONTROL group will receive a multimodal intravenous analgesia protocol alone for the postoperative pain management after the surgical open repair of an aortic abdominal aneurysm.\n\nThe multimodal intravenous analgesia protocol consists in the association of intravenous infusion of 1 g of Acetaminophen every 6 h and intravenous patient-controlled analgesia (PCA) with Chlorhydrate of Morphine 1 mg/ml.', 'interventionNames': ['Drug: PCA with Chlorhydrate of Morphine', 'Drug: Acetaminophen']}], 'interventions': [{'name': 'TAP block', 'type': 'PROCEDURE', 'otherNames': ['Transversus Abdominis Plane Block'], 'description': 'The aim of the Transversus Abdominis Plane (TAP) Block is to deposit local anesthetic in the plane between the internal oblique and the transversus abdominis muscles targeting the spinal nerves in this plane. The local anesthetic used in the ETAP study is Ropivacaine 0.375%. 2 ultrasound-guided injections of 10 ml will be performed on each side of the abdominal wall: 1 subcostal injection and 1 supra-iliac injection.', 'armGroupLabels': ['TAP BLOCK']}, {'name': 'PCA with Chlorhydrate of Morphine', 'type': 'DRUG', 'otherNames': ['Patient Controlled Analgesia (PCA)'], 'description': "Doses of 1 mg of Chlorhydrate of Morphine will be delivered intravenously by the Patient Controlled Analgesia (PCA) pump. The PCA pump is a computerized pump which contains a syringe of 1 mg/ml of Chlorhydrate of Morphine as prescribed by the physician in charge of the patient, and connected directly to a patient's intravenous line. Doses of Chlorhydrate of Morphine can be self-administered by the patient as needed by the having the patient press a button.", 'armGroupLabels': ['CONTROL', 'TAP BLOCK']}, {'name': 'Acetaminophen', 'type': 'DRUG', 'otherNames': ['Paracetamol'], 'description': '1 g of Acetaminophen will be given intravenously each 6 h during 48 hours after the surgical procedure.', 'armGroupLabels': ['CONTROL', 'TAP BLOCK']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25000', 'city': 'Besançon', 'state': 'Doubs', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Julien Chenet, MD', 'role': 'CONTACT', 'email': 'julchenet@gmail.com', 'phone': '+33381669121'}, {'name': 'Guillaume Besch, MD', 'role': 'CONTACT', 'email': 'guillaume.besch@gmail.com', 'phone': '+33381668166'}, {'name': 'Julien Chenet, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Emmanuel Samain, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sébastien Pili-Floury, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Simon Rinckenbach, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Guillaume Besch, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Thomas Levy, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Eviane Farah, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Angeline Chopard-Guillemin, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Marie-Hélène Tripard, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Patrick Lemounaud, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mazen Al Sayed Obeid, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Emilie Ducroux, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Stéphanie Villeminey, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Vincenzo Ritucci, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Vivien Salignon', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU Besançon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}], 'centralContacts': [{'name': 'Julien Chenet, MD', 'role': 'CONTACT', 'email': 'julchenet@gmail.com', 'phone': '+33(0)622640818'}, {'name': 'Guillaume Besch, MD', 'role': 'CONTACT', 'email': 'guillaume.besch@gmail.com', 'phone': '+33(0)677897039'}], 'overallOfficials': [{'name': 'Julien Chenet, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Régional Universitaire de Besancon'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Besancon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Julien CHENET', 'investigatorAffiliation': 'Centre Hospitalier Universitaire de Besancon'}}}}