Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-25 @ 9:25 PM
Study NCT ID:
NCT05742256
Status:
UNKNOWN
Last Update Posted:
2023-02-23
First Post:
2023-02-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Oxycodone in Combination With Parathoracic Nerve Block is Used for Postoperative Analgesia in Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010098', 'term': 'Oxycodone'}, {'id': 'D017409', 'term': 'Sufentanil'}], 'ancestors': [{'id': 'D003061', 'term': 'Codeine'}, {'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': 'D005283', 'term': 'Fentanyl'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 159}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-15', 'studyFirstSubmitDate': '2023-02-14', 'studyFirstSubmitQcDate': '2023-02-15', 'lastUpdatePostDateStruct': {'date': '2023-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The main indicators were NRS scores at rest and cough at 24 h postoperatively.', 'timeFrame': 'at 24h after surgery', 'description': 'NRS (numerical rating scale) is composed of 11 numbers from 0 to 10, and patients use 11 numbers from 0 to 10 to describe the intensity of pain, and the higher the number, the more severe the pain.'}], 'secondaryOutcomes': [{'measure': 'Time to double-lumen tracheal extraction', 'timeFrame': 'Within two hours after surgery', 'description': 'Time to double-lumen tracheal extraction'}, {'measure': 'NRS score at rest and cough', 'timeFrame': 'at 2h , 4h, 12h, 48h after surgery', 'description': 'NRS (numerical rating scale) is composed of 11 numbers from 0 to 10, and patients use 11 numbers from 0 to 10 to describe the intensity of pain, and the higher the number, the more severe the pain.'}, {'measure': 'sedation score (Ramsay sedation score)', 'timeFrame': 'at 2 h , 4 h , 12 h ,24 h,48 h postoperatively', 'description': 'The Ramsay sedation score is the most widely used sedation scoring criterion in clinical practice. It is divided into six levels, reflecting three levels of wakefulness and three levels of sleep. The higher the level, the deeper the level of sedation.'}, {'measure': 'sufentanil consumption', 'timeFrame': 'Within 48 hours after surgery', 'description': 'sufentanil consumption'}, {'measure': 'oxycodone consumption', 'timeFrame': 'Within 48 hours after surgery', 'description': 'oxycodone consumption'}, {'measure': 'analgesic pump compressions', 'timeFrame': 'Within 48 hours after surgery', 'description': 'analgesic pump compressions'}, {'measure': 'additional analgesic doses', 'timeFrame': 'Within 48 hours after surgery', 'description': 'additional analgesic doses'}, {'measure': 'incidence of adverse reactions: nausea, vomiting, respiratory depression, dizziness, itchin', 'timeFrame': 'Within 48 hours after surgery', 'description': 'incidence of adverse reactions: nausea, vomiting, respiratory depression, dizziness, itchin'}, {'measure': 'gastrointestinal recovery (exhaust time)', 'timeFrame': 'Within 48 hours after surgery', 'description': 'gastrointestinal recovery (exhaust time)'}, {'measure': 'laboratory results of C-reactive protein 1 day before and after surgery', 'timeFrame': 'Within 48 hours after surgery', 'description': 'laboratory results of C-reactive protein 1 day before and after surgery'}, {'measure': 'laboratory results of interleukin-6 laboratory test 1 day before and after surgery', 'timeFrame': 'Within 48 hours after surgery', 'description': 'laboratory results of interleukin-6 laboratory test 1 day before and after surgery'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Oxycodone', 'Postoperative analgesia', 'lung cancer', 'thoracic paravertebral nerve block'], 'conditions': ['Oxycodone']}, 'referencesModule': {'references': [{'pmid': '37844986', 'type': 'DERIVED', 'citation': 'Wang Y, Wu G, Liu Z, Wei X, Feng H, Su J, Shi P. Effect of oxycodone combined with ultrasound-guided thoracic paravertebral nerve block on postoperative analgesia in patients with lung cancer undergoing thoracoscopic surgery: protocol for a randomised controlled study. BMJ Open. 2023 Oct 16;13(10):e074416. doi: 10.1136/bmjopen-2023-074416.'}]}, 'descriptionModule': {'briefSummary': 'In this study, the effect of oxycodone combined with ultrasound-guided paravertebral nerve block on the postoperative analgesic effect of thoracoscopic lung cancer was investigated, and the effect and reasonable dose of oxycodone were explored, which provided a reference for the clinical multimodal analgesia after thoracoscopic lung cancer surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male or female, age \\> 60 years\n2. Patients undergoing thoracoscopic lobectomy\n3. ASA (American Academy of Anesthesiologists) Grades I-III\n4. There were no obvious abnormalities in heart, liver, and kidney function\n5. Sign the informed consent form for this clinical study\n\nExclusion Criteria:\n\n1. History of oxycodone or sufentanil allergy\n2. Renal or hepatic dysfunction\n3. History of drug or alcohol abuse\n4. Psychiatric disorders: schizophrenia, epilepsy, Parkinson's disease, myasthenia gravis\n5. Those who have difficulty communicating due to coma, severe dementia, speech barrier, or those who cannot cooperate due to other diseases.\n6. People with head trauma or other brain diseases -"}, 'identificationModule': {'nctId': 'NCT05742256', 'briefTitle': 'Oxycodone in Combination With Parathoracic Nerve Block is Used for Postoperative Analgesia in Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Qianfoshan Hospital'}, 'officialTitle': 'Effect of Oxycodone Combined With Ultrasound Guided Thoracic Paravertebral Nerve Block on Postoperative Analgesia in Patients With Lung Cancer Undergoing Thoracoscopic Surgery', 'orgStudyIdInfo': {'id': 'YXLL-KY-2022(116)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test group 1(OCA group)', 'interventionNames': ['Drug: Oxycodone 1mg/kg']}, {'type': 'EXPERIMENTAL', 'label': 'Test group 2(OCB group)', 'interventionNames': ['Drug: Oxycodone 1.5mg/kg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group(SF group)', 'interventionNames': ['Drug: Sufentanil']}], 'interventions': [{'name': 'Oxycodone 1mg/kg', 'type': 'DRUG', 'otherNames': ['Oxycodone'], 'description': 'Test group 1 (OCA group):oxycodone 1mg/kg + flurbiprofen 50mg + ondansetron 16mg + 0.9% normal saline diluted to 100ml', 'armGroupLabels': ['Test group 1(OCA group)']}, {'name': 'Oxycodone 1.5mg/kg', 'type': 'DRUG', 'description': 'Test group 2 (OCB group): oxycodone 1.5mg/kg + flurbiprofen 50mg + ondansetron 16mg + 0.9% normal saline diluted to 100ml.', 'armGroupLabels': ['Test group 2(OCB group)']}, {'name': 'Sufentanil', 'type': 'DRUG', 'description': 'Control group (SF group): sufentanil 2ug/kg + flurbiprofen + ondansetron 16mg + 0.9% normal saline diluted to 100ml.', 'armGroupLabels': ['Control group(SF group)']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Pengcai Shi, Chief physician', 'role': 'CONTACT', 'email': 'shipc1997@163.com', 'phone': '13791126828'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qianfoshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief physician，Master Tutor', 'investigatorFullName': 'Pengcai Shi', 'investigatorAffiliation': 'Qianfoshan Hospital'}}}}