Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-02-20 @ 6:01 PM
Study NCT ID:
NCT05282251
Status:
RECRUITING
Last Update Posted:
2024-05-20
First Post:
2021-10-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intrapleural Nebulization of Bupivacain to Reduce Postoperative Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008171', 'term': 'Lung Diseases'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020910', 'term': 'Ketorolac'}], 'ancestors': [{'id': 'D007213', 'term': 'Indomethacin'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-07-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-17', 'studyFirstSubmitDate': '2021-10-10', 'studyFirstSubmitQcDate': '2022-03-07', 'lastUpdatePostDateStruct': {'date': '2024-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to first rescue analgesia', 'timeFrame': 'The first 24 hours postoperatively'}], 'secondaryOutcomes': [{'measure': 'Total opioid consumption', 'timeFrame': 'The first 24 hours postoperatively'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Diseases']}, 'descriptionModule': {'briefSummary': "Thoracic surgery is now common and as other surgeries evolution of minimally invasive techniques is employed. Video-assisted thoracic surgery (VATS) produces little scar but may produce severe pain that may affect the pulmonary function. Many procedure was developed like intercostal nerve block which require injections at multiple levels, Insertion of local anaesthetic (LA) in the surgical drain but that was dangerous due to the large amount of LA and not sufficient to completely eliminate pain. Bupvicaine nebulization, through surgical port which won't make any other wound, thought to be sufficient because Nebulization will enable us better distribution and less amounts of LA. Bupvicaine is local anaesthetic amide group that works by blocking sodium channels thus preventing progression of action potential."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients that reach American socity of anesthesiologist class 1-3\n* Scheduled for VATS surgery under general anesthesia.\n\nExclusion Criteria:\n\n* ● Allergy to local anesthetics\n\n * Patient with pleural inflammation due to recent pneumonia\n * Patients who are unable or unwilling to perform spirometer test\n * Renal dysfunction: (Elevated creatinine \\> 2 mg\\\\dl)\n * Hepatic dysfunction: (Elevated hepatic enzymes three times above normal value)\n * History of addiction'}, 'identificationModule': {'nctId': 'NCT05282251', 'briefTitle': 'Intrapleural Nebulization of Bupivacain to Reduce Postoperative Pain', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Pain Managment After VATS to Reduce Postoperative Pain and Improve Pulmonary Function', 'orgStudyIdInfo': {'id': 'Pain managment after VATS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intrapleural bupivacine nebulization', 'description': 'Intrapleural nebulization of bupivacine (10 ml of bupivacaine 0.5%) + Intravenous normal saline as a placebo', 'interventionNames': ['Drug: Intrapleural bupivacine nebulization']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intravenous paracetamol and ketorolac', 'description': 'Intravenous analgesia: paracetamol (one gram) and Ketorolac (30 mg) + Intrapleural normal saline (10 ml) as a placebo', 'interventionNames': ['Drug: Intravenous paracetamol and ketorolac']}], 'interventions': [{'name': 'Intrapleural bupivacine nebulization', 'type': 'DRUG', 'description': 'Intrapleural nebulization of bupivacine (10 ml of bupivacaine 0.5%) + Intravenous normal saline as a placebo', 'armGroupLabels': ['Intrapleural bupivacine nebulization']}, {'name': 'Intravenous paracetamol and ketorolac', 'type': 'DRUG', 'description': 'Intravenous analgesia: paracetamol (one gram) and Ketorolac (30 mg) + Intrapleural normal saline (10 ml) as a placebo', 'armGroupLabels': ['Intravenous paracetamol and ketorolac']}]}, 'contactsLocationsModule': {'locations': [{'zip': '880', 'city': 'Asyut', 'state': 'Assuit', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Assuit Assuit University, Bachelor', 'role': 'CONTACT', 'email': 'Emobarak94@gmail.com', 'phone': '01094878158', 'phoneExt': '01551434651'}], 'facility': 'Assiut University', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Esam Moubarak Sahin', 'role': 'CONTACT', 'email': 'Emobarak94@gmail.com', 'phone': '01094878158', 'phoneExt': '01551434651'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident doctor', 'investigatorFullName': 'Essam El-den Moubark Mohammed Hussein', 'investigatorAffiliation': 'Assiut University'}}}}