Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2026-03-14 @ 5:56 PM
Study NCT ID:
NCT02677532
Status:
COMPLETED
Last Update Posted:
2016-02-09
First Post:
2016-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epidural Versus Wound Infusion Plus Morphine Bolus in Open Abdominal Aortic Aneurysm Repair
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': 'D000082', 'term': 'Acetaminophen'}, {'id': 'D009020', 'term': 'Morphine'}, {'id': 'D000077554', 'term': 'Levobupivacaine'}], 'ancestors': [{'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'}, {'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D002045', 'term': 'Bupivacaine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-08', 'studyFirstSubmitDate': '2016-01-29', 'studyFirstSubmitQcDate': '2016-02-08', 'lastUpdatePostDateStruct': {'date': '2016-02-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-02-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Incidence of postoperative cardiovascular adverse events', 'timeFrame': 'Intra-hospital follow-up of up to 3 months after surgery'}, {'measure': 'Incidence of postoperative pulmonary complications', 'timeFrame': 'Intra-hospital follow-up of up to 3 months after surgery'}], 'primaryOutcomes': [{'measure': 'Average postoperative pain assessed with numeric rating scale (NRS) in the first 48 hours', 'timeFrame': 'Average of the NRS recorded at the different time-points (up to 48 hours after emergence from general anaesthesia)'}], 'secondaryOutcomes': [{'measure': 'Need for rescue doses of morphine at each time-point', 'timeFrame': '0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia', 'description': 'Need for a bolus of 5 mg intravenous morphine to relief pain'}, {'measure': 'Number of patients requiring oxygen administration at each time-point', 'timeFrame': '0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia'}, {'measure': 'Number of patients that have restored bowel function at each time-point', 'timeFrame': '0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia', 'description': 'Time to first stool analysis'}, {'measure': 'Number of patients whose urinary catheter was removed at each time-point', 'timeFrame': '0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia', 'description': 'Time to catheter removal analysis'}, {'measure': 'Number of patients that have restored ability to walk at each time-point', 'timeFrame': '0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia'}, {'measure': 'Non-invasive blood pressure (mmHg) at each time-point', 'timeFrame': '0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia', 'description': 'Blood pressure (systolic, diastolic, mean in mmHg)'}, {'measure': 'Length of hospital stay', 'timeFrame': 'Follow-up of up to 3 months after surgery'}, {'measure': 'Heart rate (bpm) at each time-point', 'timeFrame': '0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia'}, {'measure': 'Incidence of postoperative nausea and vomiting', 'timeFrame': '0, 4, 8, 12, 24, 36, 48 hours after emergence from general anaesthesia'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to determine wether continuous wound infusion with local anaesthetic plus a single dose intravenous morphine is non-inferior to postoperative analgesia provided with continuous thoracic epidural infusion of local anaesthetic plus opiate, in patients undergoing open abdominal aortic aneurism repair.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Scheduled for elective open aortic aneurism repair\n\nExclusion Criteria:\n\n* Patient refusal\n* Platelet count \\< 80\\*10\\^3/mcL\n* International Normalised Ratio \\> 1.5\n* Other contraindications to the placement of epidural catheter, including ongoing anti platelet or anticoagulant treatment not suspended according to national guidelines'}, 'identificationModule': {'nctId': 'NCT02677532', 'acronym': 'APERIVIP', 'briefTitle': 'Epidural Versus Wound Infusion Plus Morphine Bolus in Open Abdominal Aortic Aneurysm Repair', 'organization': {'class': 'OTHER', 'fullName': 'University of Genova'}, 'officialTitle': "Analgesia Postoperatoria Mediante Catetere Perdurare e Analgesia Postoperatoria Mediante Infusione Continua Periferia Nell'Intervento Chirurgico Per Riparazione Chirurgica di Aneurismi Dell'Aorta Addominale: Tecniche a Confronto", 'orgStudyIdInfo': {'id': 'APERIVIP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Epidural infusion', 'description': 'Thoracic epidural bolus of 10 ml levobupivacaine 0.25% plus sufentanil 0.15 mcg/kg before end of surgery, followed by continuous epidural infusion of 0.12% levobupivacaine plus 0.4 mcg/ml at 5 ml/h infusion rate for 48 hours.', 'interventionNames': ['Drug: Paracetamol', 'Drug: Levobupivacaine epidural bolus', 'Drug: Sufentanil epidural bolus', 'Device: Epidural catheter placement', 'Drug: Levobupivacaine plus sufentanil epidural infusion']}, {'type': 'EXPERIMENTAL', 'label': 'Wound infusion plus morphine bolus', 'description': 'Intravenous slow bolus of 10 mg morphine, wound infiltration with 10 ml levobupivacaine 0.5%, followed by pre-peritoneal continuous wound infusion of levobupivacaine 0.25% at 4 ml/h infusion rate for 48 hours.', 'interventionNames': ['Drug: Paracetamol', 'Drug: Levobupivacaine wound infiltration', 'Drug: Morphine', 'Device: Wound infusion catheters placement', 'Drug: Levobupivacaine wound infusion']}], 'interventions': [{'name': 'Paracetamol', 'type': 'DRUG', 'description': '1 g every 8 hours', 'armGroupLabels': ['Epidural infusion', 'Wound infusion plus morphine bolus']}, {'name': 'Levobupivacaine wound infiltration', 'type': 'DRUG', 'description': 'Wound infiltration with 10 ml levobupivacaine 0.5%', 'armGroupLabels': ['Wound infusion plus morphine bolus']}, {'name': 'Levobupivacaine epidural bolus', 'type': 'DRUG', 'description': 'Epidural bolus of 10 ml 0.25% levobupivacaine', 'armGroupLabels': ['Epidural infusion']}, {'name': 'Sufentanil epidural bolus', 'type': 'DRUG', 'description': 'Epidural bolus of 0.15 mcg/kg sufentanil', 'armGroupLabels': ['Epidural infusion']}, {'name': 'Morphine', 'type': 'DRUG', 'description': 'Intravenous slow bolus of 10 mg morphine', 'armGroupLabels': ['Wound infusion plus morphine bolus']}, {'name': 'Epidural catheter placement', 'type': 'DEVICE', 'description': 'Thoracic epidural catheter placement in the T7-T8 or T8-T9 intervertebral space', 'armGroupLabels': ['Epidural infusion']}, {'name': 'Wound infusion catheters placement', 'type': 'DEVICE', 'description': 'Pre-peritoneal placement of two catheters for wound infusion', 'armGroupLabels': ['Wound infusion plus morphine bolus']}, {'name': 'Levobupivacaine plus sufentanil epidural infusion', 'type': 'DRUG', 'description': 'Epidural infusion of levobupivacaine 0.12% plus sufentanil 0.4 mcg/ml at 4 ml/h for 48 h', 'armGroupLabels': ['Epidural infusion']}, {'name': 'Levobupivacaine wound infusion', 'type': 'DRUG', 'description': 'Wound infusion with levobupivacaine 0.25% at 4 ml/h for 48 h', 'armGroupLabels': ['Wound infusion plus morphine bolus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16100', 'city': 'Genova', 'state': 'Genova', 'country': 'Italy', 'facility': 'UO Anestesia e Terapia Intensiva, IRCCS AOU San-Martino IST', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Genova', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Paolo Pelosi', 'investigatorAffiliation': 'University of Genova'}}}}