Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-02-25 @ 10:04 PM
Study NCT ID:
NCT02662660
Status:
COMPLETED
Last Update Posted:
2016-01-25
First Post:
2016-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analgesia iv vs Epidural Analgesia vs Port-sites Infiltration After Laparoscopic Sleeve Gastrectomy
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': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D015360', 'term': 'Analgesia, Epidural'}, {'id': 'D004177', 'term': 'Dipyrone'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D000632', 'term': 'Aminopyrine'}, {'id': 'D047069', 'term': 'Pyrazolones'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 147}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-20', 'studyFirstSubmitDate': '2016-01-17', 'studyFirstSubmitQcDate': '2016-01-20', 'lastUpdatePostDateStruct': {'date': '2016-01-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative pain measured by Visual Analogic Scale', 'timeFrame': '24 hours after surgery', 'description': 'Postoperative pain will be measured by Visual Analogic Scale (VAS), ranging from 0 (absence of pain) to 10 (unbearable pain) 24 hours after surgery,'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Postoperative Pain']}, 'referencesModule': {'references': [{'pmid': '27177956', 'type': 'DERIVED', 'citation': 'Ruiz-Tovar J, Munoz JL, Gonzalez J, Zubiaga L, Garcia A, Jimenez M, Ferrigni C, Duran M. Postoperative pain after laparoscopic sleeve gastrectomy: comparison of three analgesic schemes (isolated intravenous analgesia, epidural analgesia associated with intravenous analgesia and port-sites infiltration with bupivacaine associated with intravenous analgesia). Surg Endosc. 2017 Jan;31(1):231-236. doi: 10.1007/s00464-016-4961-3. Epub 2016 May 13.'}]}, 'descriptionModule': {'briefSummary': 'A prospective randomized study of patients undergoing laparoscopic sleeve gastrectomy between 2012 and 2015 will be performed. Patients will be divided into 3 groups: Analgesia iv exclusively (Group 1), epidural analgesia+analgesia iv (Group 2) and port-sites infiltration+analgesia iv (Group 3). Pain will be quantified by means of a Visual Analogic Scale and morphine rescue needs were determined 24 hours after surgery.', 'detailedDescription': 'A prospective randomized study of patients undergoing laparoscopic sleeve gastrectomy between 2012 and 2015 will be performed. Patients will be randomized using a computerized simple randomization scheme in a 1:1:1 ratio into 3 groups: those patients receiving only intravenous analgesia (Group 1), those ones receiving intravenous analgesia associated to epidural analgesia (Group 2) and those patients receiving intravenous analgesia associated with port-sites infiltration with bupivacaine. Pain quantification as measured by Visual Analogic Scale (VAS), ranging from 0 (absence of pain) to 10 (unbearable pain) will be evaluated 24 hours after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* body mass index (BMI) \\>40 Kg/m2\n* BMI \\> 35 Kg/m2 with the presence of comorbidities associated to obesity\n\nExclusion Criteria:\n\n* patients undergoing other bariatric techniques\n* severe underlying cardiovascular diseases\n* chronic renal failure\n* hepatic dysfunction\n* previous foregut surgery\n* patients with any contraindication for bariatric surgery'}, 'identificationModule': {'nctId': 'NCT02662660', 'briefTitle': 'Analgesia iv vs Epidural Analgesia vs Port-sites Infiltration After Laparoscopic Sleeve Gastrectomy', 'organization': {'class': 'OTHER', 'fullName': 'Hospital General Universitario Elche'}, 'officialTitle': 'Postoperative Pain After Laparoscopic Sleeve Gastrectomy: Comparison of Isolated Intravenous Analgesia, Epidural Analgesia Associated With Analgesia iv and Port-sites Infiltration With Bupivacaine Associated With Analgesia iv', 'orgStudyIdInfo': {'id': 'HGUE 16-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Port-sites infiltration:Bupivacaine0,25%', 'description': 'Port-sites infiltration will be performed with 10 ml of Bupivacaine 0.25%, applying 2 ml under the aponeurotic layer in each port. Associated intravenous analgesia will include Metamizole 2g/8h and Acetaminophen 1g/8h, alternating every 4 hours.', 'interventionNames': ['Drug: Port-sites infiltration:Bupivacaine0.25%', 'Drug: Metamizole and Acetaminophen iv']}, {'type': 'EXPERIMENTAL', 'label': 'Epidural analgesia:Levobupivacaine0.125%', 'description': 'Epidural analgesia consists in the placement of a thoracic epidural catheter inserted at the level T6-T7 and administration of a continuous perfusion of Levobupivacaine 0.125% 6ml/h.\n\nAssociated intravenous analgesia will include Metamizole 2g/8h and Acetaminophen 1g/8h, alternating every 4 hours.', 'interventionNames': ['Drug: Epidural analgesia:Levobupivacaine0,125%', 'Drug: Metamizole and Acetaminophen iv']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Metamizole and Acetaminophen iv', 'description': 'Associated intravenous analgesia will include Metamizole 2g/8h and Acetaminophen 1g/8h, alternating every 4 hours.', 'interventionNames': ['Drug: Metamizole and Acetaminophen iv']}], 'interventions': [{'name': 'Port-sites infiltration:Bupivacaine0.25%', 'type': 'DRUG', 'otherNames': ['Port-sites infiltration with bupivacaine'], 'description': 'Port-sites infiltration will be performed with 10 ml of Bupivacaine 0.25%, applying 2 ml under the aponeurotic layer in each port.', 'armGroupLabels': ['Port-sites infiltration:Bupivacaine0,25%']}, {'name': 'Epidural analgesia:Levobupivacaine0,125%', 'type': 'DRUG', 'otherNames': ['Epidural analgesia'], 'description': 'Port-sites infiltration will be performed with 10 ml of Bupivacaine 0.25%, applying 2 ml under the aponeurotic layer in each port.', 'armGroupLabels': ['Epidural analgesia:Levobupivacaine0.125%']}, {'name': 'Metamizole and Acetaminophen iv', 'type': 'DRUG', 'otherNames': ['Analgesia iv'], 'description': 'Associated Intravenous analgesia include Metamizole 2g/8h and Acetaminophen 1g/8h, alternating every 4 hours.', 'armGroupLabels': ['Epidural analgesia:Levobupivacaine0.125%', 'Metamizole and Acetaminophen iv', 'Port-sites infiltration:Bupivacaine0,25%']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Manuel Duran, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital General Elche'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital General Universitario Elche', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Jaime Ruiz-Tovar, MD, PhD', 'investigatorAffiliation': 'Hospital General Universitario Elche'}}}}