Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-01-01 @ 9:39 AM
Study NCT ID:
NCT05848635
Status:
UNKNOWN
Last Update Posted:
2023-05-08
First Post:
2023-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hydromorphone for Perioperative Analgesia in Lung Tumor Ablation Parallel Controlled
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004091', 'term': 'Hydromorphone'}], 'ancestors': [{'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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 88}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2024-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-28', 'studyFirstSubmitDate': '2023-04-09', 'studyFirstSubmitQcDate': '2023-04-28', 'lastUpdatePostDateStruct': {'date': '2023-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Analgesic efficiency', 'timeFrame': 'The analgesia is evaluated at 1 hour before surgery, 5 minutes after the beginning of ablation', 'description': 'effective cases / total cases \\* 100%. The NRS（Numeric Rating Scale） score ≤3 at all evaluation time points is considered as effective analgesia.'}], 'secondaryOutcomes': [{'measure': 'Incidence of adverse reactions', 'timeFrame': 'perioperative period', 'description': 'cases of adverse reactions / total cases \\* 100%'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulmonary Nodule', 'Ablation']}, 'descriptionModule': {'briefSummary': 'This randomized, parallel controlled, single blind trial is designed to evaluate the efficacy and safety of hydromorphone versus morphine for perioperative analgesia in lung tumor ablation.', 'detailedDescription': 'Although the consensus of relevant guidelines and clinical studies recommend the use of opioids for perioperative analgesia in pulmonary tumor ablation surgery, there is a lack of specific analgesic programs for clinical reference. In view of the advantages of clinical application of hydromorphone and the lack of evidence for its application in perioperative analgesia of pulmonary tumor ablation, this study aims to explore the efficacy and safety of hydromorphone in perioperative analgesia of pulmonary tumor ablation, and provide some reference and suggestions for perioperative analgesia of pulmonary tumor ablation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Voluntarily attend and sign the informed consent form in person;\n* Patients undergoing selective pulmonary tumor ablation;\n* The Eastern Collaborative Oncology Group (ECOG) defines an activity status score of 2 or less;\n* The estimated survival time is more than 3 months;\n* Age 18-80, both sexes.\n\nExclusion Criteria:\n\n* Severe coagulation dysfunction that cannot be corrected;\n* History of severe cardio-cerebrovascular and respiratory diseases;\n* Patients allergic to test drugs or contrast media;\n* Patients with opioid addiction;\n* Patients with cognitive dysfunction;\n* Participated in other clinical investigators within three months;\n* Investigators or their family members directly involved in the trial;\n* Those who are deemed unfit to participate in the study by the investigator.'}, 'identificationModule': {'nctId': 'NCT05848635', 'briefTitle': 'Hydromorphone for Perioperative Analgesia in Lung Tumor Ablation Parallel Controlled', 'organization': {'class': 'OTHER', 'fullName': 'Qianfoshan Hospital'}, 'officialTitle': 'Hydromorphone for Perioperative Analgesia in Lung Tumor Ablation Parallel Controlled ：A Randomized, Parallel Controlled Trial', 'orgStudyIdInfo': {'id': '20221209'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: Lung tumor ablation using hydromorphone for pain control and anaesthesia', 'description': "Premedication:hydromorphone is started 15min before surgery with a single subcutaneous injection of 2mg.\n\nIntraoperative administration:NRS（Numeric Rating Scale）≥7 during operation, 2mg hydromorphone is injected intravenously and slowly pushed for 2-3 minutes.\n\nPostoperative administration:The drug is administered as needed according to the patient's postoperative pain, 2mg/time.", 'interventionNames': ['Drug: Hydromorphone Hydrochloride']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active Comparator:Lung tumor ablation using morphine for pain control and anaesthesia', 'description': "Premedication:morphine is started 15min before surgery with a single subcutaneous injection of 10mg.\n\nIntraoperative administration:NRS（Numeric Rating Scale）≥7 during operation, 10mg morphine is injected intravenously and slowly pushed for 2-3 minutes.\n\nPostoperative administration:The drug is administered as needed according to the patient's postoperative pain, 10mg/time.", 'interventionNames': ['Drug: Morphine hydrochloride']}], 'interventions': [{'name': 'Hydromorphone Hydrochloride', 'type': 'DRUG', 'otherNames': ['Lung tumor ablation using hydromorphone hydrochloride'], 'description': 'Drug: Hydromorphone Hydrochloride Hydromorphone hydrochloride injection is used for perioperative lung tumor ablation', 'armGroupLabels': ['Experimental: Lung tumor ablation using hydromorphone for pain control and anaesthesia']}, {'name': 'Morphine hydrochloride', 'type': 'DRUG', 'otherNames': ['Lung tumor ablation using morphine hydrochloride'], 'description': 'Drug: Morphine Hydrochloride Morphine hydrochloride injection is used for perioperative lung tumor ablation', 'armGroupLabels': ['Active Comparator:Lung tumor ablation using morphine for pain control and anaesthesia']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Xin Ye, graduate', 'role': 'CONTACT', 'email': 'yexintaian@aliyun.com', 'phone': '18906417755'}, {'name': 'ZhiGang Wei, doctorate', 'role': 'CONTACT', 'phone': '18615287195'}], 'overallOfficials': [{'name': 'Xin Ye, graduate', 'role': 'STUDY_DIRECTOR', 'affiliation': 'head of intervention department'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qianfoshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}