Ignite Creation Date:
2025-12-24 @ 8:01 PM
Ignite Modification Date:
2026-02-25 @ 4:13 AM
Study NCT ID:
NCT02035904
Status:
UNKNOWN
Last Update Posted:
2017-03-03
First Post:
2014-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Levobupivacaine Prolonged Wound Infusion for Postoperative Pain Relief After Breast Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059787', 'term': 'Acute Pain'}, {'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D009020', 'term': 'Morphine'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-03-01', 'studyFirstSubmitDate': '2014-01-11', 'studyFirstSubmitQcDate': '2014-01-11', 'lastUpdatePostDateStruct': {'date': '2017-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'reduction in oral Tramadol-Paracetamol combination consumption from 2nd to 14th day after mastectomy', 'timeFrame': 'from day 2 to 14'}], 'secondaryOutcomes': [{'measure': 'reduction in pain values at rest and movement in treatment group', 'timeFrame': '14 days'}, {'measure': 'incidence of drug-related side effects', 'timeFrame': 'up to 14 days', 'description': 'local anesthetic toxicity, opioid side effects'}, {'measure': 'incidence of catheter-related surgical complications', 'timeFrame': 'up to 1 month', 'description': 'infections, healing retardation'}, {'measure': 'earlier upper limb rehabilitation', 'timeFrame': 'up to 1 month', 'description': 'physiatric evaluations'}, {'measure': 'earlier return to social activities and good quality of life', 'timeFrame': 'up to 1 month', 'description': 'validated SF-36 questionnaire'}, {'measure': 'different chronic pain incidence', 'timeFrame': 'up to 3 months', 'description': 'phone interview at 1 and 3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Acute Pain', 'Chronic Pain', 'Wound Infusion', 'Mastectomy']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate efficacy and safety of long term (14 days) wound infusion with levobupivacaine in patients with breast cancer undergoing mastectomy with immediate breast reconstruction: this is a double blind, randomized, parallel group study. The study moves from the concept that nociceptive stimulus last further than 48 hours after surgical intervention: long term analgesia is necessary to provide a real benefit to the patient and provide central sensitization. Intralesional catheter is placed at the end of surgery. In the first 24 postoperative hours we provide continuous wound infusion with levobupivacaine 0,25% 5ml/h with morphine Patient Controlled Analgesia (PCA) when NRS \\>4. From the second postoperative day morphine PCA is removed and patients are randomized to receive levobupivacaine 0,25% or saline, released with 5 ml boluses and lock-out of 2 hours, with rescue analgesia with tramadol 37,5 mg + acetaminophen 325 mg oral fix combination (Patrol). Intralesional catheter is taken off 14 days after surgical intervention or after 36 hours of non-use.\n\nPain evaluation (NRS at rest and movement) and oral rescue doses consumption are performed; pain physicians also care about any catheter-related or drug-related side effect, registering number of total boluses. Patients are provided with a home diary for pain scores to be filled and brought back when surgical visit is performed. A phone interview at 1 and 3 month is performed to investigate pain chronicization.\n\nSurgical evaluation is provided, also to establish any catheter-related infective or healing complication.\n\nPhysiatric evaluation before the intervention and 1 and 3 months is provided to ensure rehabilitation process.\n\nA validated questionnaire (short form 36/ SF-36) must be filled by all patients, to understand differences in return to a normal quality of life and to social activities between the two groups.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* F; age 18 to 70\n* American Society of Anesthesiologists (ASA) I e II;\n* breast cancer ( DIN 2 e 3, o LIN 2 e 3 sec. Tavassoli) scheduled for nipple-sparing mastectomy, simple mastectomy, skin-sparing mastectomy, skin-reducing mastectomy c, lymphnode biopsy and axillary dissection;\n* immediate sub-pectoral prosthetic reconstruction;\n* signed informed consent.\n\nExclusion Criteria:\n\n* preexisting pectoral, axillar, thoracic homolateral pain\n* habitual opioid consumption;\n* drug-alcoholics addiction ;\n* ICU postoperative recovery;\n* kidney failure (creatinin \\> 2 g/dl, creatinin \\<clearance 30 ml/h) and/or hepatic failure (cholinesterase \\< 2000 UI);\n* cardiac arrhythmias o;\n* Epilepsy;\n* Psychiatric, cognitive disorders, mental retardation;\n* Coagulopathies (INR \\> 2, activated partial thromboplastin time - aPTT\\>44 sec);\n* platelet count less than 100.000/mm3;\n* BMI \\> 30;\n* Allergies to study drugs.'}, 'identificationModule': {'nctId': 'NCT02035904', 'briefTitle': 'Levobupivacaine Prolonged Wound Infusion for Postoperative Pain Relief After Breast Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione IRCCS Policlinico San Matteo di Pavia'}, 'orgStudyIdInfo': {'id': '2011-006331-35'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Levobupivacaine', 'description': 'Levobupivacaine Patient Controlled Infusion 5 ml 0,25%, lock out 2 hours', 'interventionNames': ['Drug: Levobupivacaine PCIA (Patient Controlled Intrawound Analgesia)', 'Drug: Levobupivacaine continuous infusion', 'Device: intrawound infusion catheter', 'Drug: morphine', 'Drug: Patrol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline', 'description': 'patient controlled infusion 5 ml bolus, lock out 2 hours', 'interventionNames': ['Drug: saline', 'Drug: Levobupivacaine continuous infusion', 'Device: intrawound infusion catheter', 'Drug: morphine', 'Drug: Patrol']}], 'interventions': [{'name': 'Levobupivacaine PCIA (Patient Controlled Intrawound Analgesia)', 'type': 'DRUG', 'description': 'patient controlled infusion from the 2nd day after surgery', 'armGroupLabels': ['Levobupivacaine']}, {'name': 'saline', 'type': 'DRUG', 'description': 'patient controlled infusion from the 2nd day after surgery', 'armGroupLabels': ['Saline']}, {'name': 'Levobupivacaine continuous infusion', 'type': 'DRUG', 'description': 'Continuous infusion Levobupivacaine 0,25% 5ml/h for 24 hs in all patients', 'armGroupLabels': ['Levobupivacaine', 'Saline']}, {'name': 'intrawound infusion catheter', 'type': 'DEVICE', 'description': 'placed by surgeon at the end surgery in all patients', 'armGroupLabels': ['Levobupivacaine', 'Saline']}, {'name': 'morphine', 'type': 'DRUG', 'description': 'PCA with morphine: 0,5 mg/ml bolus 1 mg lock-out 5 min max 20 mg in 4 hs - for the first 24 hs as rescue analgesia', 'armGroupLabels': ['Levobupivacaine', 'Saline']}, {'name': 'Patrol', 'type': 'DRUG', 'description': 'tramadol-paracetamol 37,5/325 mg oral fix combination-rescue analgesia from 2nd day (after morphine PCA removal)', 'armGroupLabels': ['Levobupivacaine', 'Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27100', 'city': 'Pavia', 'state': 'Pavia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Allegri Massimo, MD', 'role': 'CONTACT', 'email': 'massimo.allegri@unipv.it', 'phone': '+390382502627'}, {'name': 'Bugada Dario, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department of Anesthesia - Pain Therapy Service', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}], 'centralContacts': [{'name': 'Allegri Massimo, MD', 'role': 'CONTACT', 'email': 'massimo.allegri@unipv.it', 'phone': '+390382502627'}], 'overallOfficials': [{'name': 'Allegri Massimo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pain Therapy Service IRCCS Policlinico S Matteo Pavia Italy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione IRCCS Policlinico San Matteo di Pavia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Massimo Allegri', 'investigatorAffiliation': 'Fondazione IRCCS Policlinico San Matteo di Pavia'}}}}