Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2026-01-29 @ 4:38 PM
Study NCT ID:
NCT03228056
Status:
UNKNOWN
Last Update Posted:
2018-04-11
First Post:
2017-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Pain After Single Port, Two Ports and Three Ports VATS Lobectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-04-09', 'studyFirstSubmitDate': '2017-06-09', 'studyFirstSubmitQcDate': '2017-07-19', 'lastUpdatePostDateStruct': {'date': '2018-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain intensity', 'timeFrame': 'up to 72 hours after the end of surgery', 'description': '0-100 mm VAS scale measured every 4 hours on standard ruler beginning from the end of the surgery'}], 'secondaryOutcomes': [{'measure': 'opioid consumption', 'timeFrame': 'up to 72 hours after the end of surgery', 'description': 'cumulative rescue morphine consumtion (PCA) in miligrams'}, {'measure': 'rate of complications', 'timeFrame': 'up to 72 hours after the end of surgery', 'description': 'frequency of postoperative complications (atelectasis, pneumonia, atrial fibrillation, urine retention, hypotension, respiatory depression, sedation)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['postoperative pain', 'videothoracoscopic surgery', 'thoracic epidural analgesia', 'lung lobectomy'], 'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This single-center, prospective, randomized controlled trial was designed to assess and compare the postoperative pain after VATS lobectomy performed though one, two and three incisions. The primary outcome measure is pain intensity measured in VAS scale. The secondary outcome measure is cumulative morphine consumption up to 72 hours after surgery', 'detailedDescription': "The best VATS technique for lobectomy has not been well defined yet. Most of the authors describe the VATS approach to lobectomy via 2 to even 4 incisions. The final step in the evolution of the technique is the use of a single-port approach. If conventional multiportal VATS is superior to open thoracotomy by virtue of minimizing surgical access trauma, then further reduction in such access trauma should yield even greater benefits. Therefore, reducing the number of wounds from three or four to just one, should, in theory, lead to less pain, paresthesia, and morbidity as well as faster recovery. However, critics of the uniportal VATS approach may raise concerns about whether this most minimally invasive surgical approach for lung surgery may compromise safety and treatment efficacy. In addition, there's the concern about true invasiveness of the procedure. This prospective, randomized controlled trial was designed to compare the postoperative pain after VATS lobectomy performed through one, two and three incisions. The primary outcome measure is pain intensity measured in VAS scale. The secondary outcome measures are cumulative morphine consumption up to 72 hours after surgery in 4-hour intervals and dynamic spirometry (PEF, FEV1 and FVC) measured daily at the bedside up to 72 hours after surgery. All patients will receive the same regimen of postoperative analgesia based on thoracic epidural block, non-steroidal anti-inflammatory drugs and rescue doses of morphine in PCA system. The side effects and complications including atelectasis, pneumonia, atrial fibrillation, urine retention, hypotension, respiratory depression and sedation will be analysed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. American Society of Anesthesiologists (ASA) physical status 1-3\n2. undergo videothoracoscopic lung lobectomy\n3. forced expiratory volume in 1 second (FEV1) \\>1,5 l/min\n4. no contraindications for epidural anesthesia\n5. ability to comprehend principles of VAS pain examination method and to communicate in accordance with them.\n\nExclusion Criteria:\n\n1. prior to the study: contraindications for local anesthesia, ASA\\>3, FEV1\\<1,5 l/min, conditions disabling the patient from comprehending the principles of VAS pain examination, known allergy to used medications.\n2. during the study: failure to place epidural catheter, decision to abandon lobar resection (e.g. in case of neoplastic dissemination), intraoperative conversion to thoracotomy, intraoperative anatomical obstacles to distribution of local anesthetics, conditions disabling the patient from pain evaluation by means of VAS method (e.g. postoperative delirium), necessity to administer other pharmaceuticals influencing pain perception (e.g. sedatives), necessity of mechanical ventilation, interruption of local anesthesia as a result of technical problems (e.g. damage or slippage of catheter).'}, 'identificationModule': {'nctId': 'NCT03228056', 'briefTitle': 'Postoperative Pain After Single Port, Two Ports and Three Ports VATS Lobectomy', 'organization': {'class': 'OTHER', 'fullName': 'Pulmonary Hospital Zakopane'}, 'officialTitle': 'Postoperative Pain After Single Port, Two Ports and Three Ports Video-assisted Thoracic Surgery Lobectomy in Cancer Patients: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'PHZakopane'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'uniportal VATS lobectomy', 'description': '* uniportal VATS lobectomy\n* thoracic epidural block (0.125% bupivacaine with epinephrine 1:50000, continuous infusion 3-4 ml/hour)\n* ketoprofene 100 mg i.v every 12 hours\n* paracetamol 1000 mg i.v every 8 hours\n* rescue doses of morphine in PCA system (bolus dose 2 mg i.v)\n* pain intensity measured in VAS scale', 'interventionNames': ['Diagnostic Test: pain intensity measured in VAS scale']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'two-ports VATS lobectomy', 'description': '* two-ports VATS lobectomy\n* thoracic epidural block (0.125% bupivacaine with epinephrine 1:50000, continuous infusion 3-4 ml/hour)\n* ketoprofene 100 mg i.v every 12 hours\n* paracetamol 1000 mg i.v every 8 hours\n* rescue doses of morphine in PCA system (bolus dose 2 mg i.v)\n* pain intensity measured in VAS scale', 'interventionNames': ['Diagnostic Test: pain intensity measured in VAS scale']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'three-ports VATS lobectomy', 'description': '* three-ports VATS lobectomy\n* thoracic epidural block (0.125% bupivacaine with epinephrine 1:50000, continuous infusion 3-4 ml/hour)\n* ketoprofene 100 mg i.v every 12 hours\n* paracetamol 1000 mg i.v every 8 hours\n* rescue doses of morphine in PCA system (bolus dose 2 mg i.v)\n* pain intensity measured in VAS scale', 'interventionNames': ['Diagnostic Test: pain intensity measured in VAS scale']}], 'interventions': [{'name': 'pain intensity measured in VAS scale', 'type': 'DIAGNOSTIC_TEST', 'description': 'Pain intensity in 0-100 mm VAS scale is measured every 4 hours on standard ruler beginning from the end of the surgery.', 'armGroupLabels': ['three-ports VATS lobectomy', 'two-ports VATS lobectomy', 'uniportal VATS lobectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34-500', 'city': 'Zakopane', 'state': 'Malopolska', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Sylweriusz Kosiński', 'role': 'CONTACT', 'email': 'kosa@mp.pl', 'phone': '602480289'}], 'facility': 'Pulmonary Hospital', 'geoPoint': {'lat': 49.29899, 'lon': 19.94885}}, {'zip': '34-500', 'city': 'Zakopane', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Sylweriusz Kosiński', 'role': 'CONTACT', 'email': 'kosa@mp.pl', 'phone': '602480289'}], 'facility': 'Pulmonary Hospital', 'geoPoint': {'lat': 49.29899, 'lon': 19.94885}}], 'centralContacts': [{'name': 'Sylweriusz Kosiński, PhD', 'role': 'CONTACT', 'email': 'kosa@mp.pl', 'phone': '602480289'}], 'overallOfficials': [{'name': 'Marcin Zieliński, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pulmonary Hospital, Zakopane, Poland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pulmonary Hospital Zakopane', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}