Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2025-12-29 @ 7:24 AM
Study NCT ID:
NCT06398834
Status:
COMPLETED
Last Update Posted:
2024-05-06
First Post:
2024-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Esketamine and Butorphanol for Post-Lobectomy Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2024-05-20', 'unreleaseDate': '2024-05-21'}], 'estimatedResultsFirstSubmitDate': '2024-05-20'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D013896', 'term': 'Thoracic Diseases'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000629870', 'term': 'Esketamine'}, {'id': 'D007649', 'term': 'Ketamine'}, {'id': 'D002077', 'term': 'Butorphanol'}], 'ancestors': [{'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The enrolled participants were randomly allocated to either the butorphanol group (Group B) or the esketamine combined with butorphanol group (Group BK) at a 1:1 ratio.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 223}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-02', 'studyFirstSubmitDate': '2024-04-23', 'studyFirstSubmitQcDate': '2024-05-01', 'lastUpdatePostDateStruct': {'date': '2024-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of chronic pain', 'timeFrame': '3 months post-surgery', 'description': "To assess the patient's subjective pain intensity through the Visual Analog Pain Scale at 3 months after surgery.\n\nThe Visual Analog Pain Scale consists of a line usually 100 mm in length. The ends are defined as the extreme limits of the parameter to be measured (pain) orientated from the left (no pain) to the right (worst pain). The patient makes a mark reflecting his or her perception, and the distance from the left endpoint to the mark is measured, in mm."}], 'secondaryOutcomes': [{'measure': 'Acute pain after surgery', 'timeFrame': 'Within 7 days after surgery', 'description': 'To assess the postoperative pain intensity of each participant through the Visual Analog Pain Scale at 6, 12 hours, and 1, 2, 3, 5, and 7 days following surgery.\n\nThe Visual Analog Pain Scale consists of a line usually 100 mm in length. The ends are defined as the extreme limits of the parameter to be measured (pain) orientated from the left (no pain) to the right (worst pain). The patient makes a mark reflecting his or her perception, and the distance from the left endpoint to the mark is measured, in mm.'}, {'measure': 'Postoperative recovery quality', 'timeFrame': 'Preoperative and within 3 days after surgery', 'description': 'The quality of recovery was assessed by 15-item quality of recovery (QoR-15) before surgery, on postoperative day (POD) 1, and POD 3.\n\nThe QoR-15 is a recently developed and validated short-form postoperative QoR score. Fifteen questions assess five domains of patient-reported health status: pain, physical comfort, physical independence, psychological support and emotional state. The 11-point numerical rating scale leads to a minimum score of 0 (very poor recovery) and a maximum score of 150 (excellent recovery).'}, {'measure': 'Intraoperative mean arterial pressure', 'timeFrame': 'During operation', 'description': "The patient's intraoperative mean arterial pressure was recorded to assess the effect of esketamine on the patient's vital signs."}, {'measure': 'Heart rate', 'timeFrame': 'During operation', 'description': "The patient's intraoperative heart rate was recorded to assess the effect of esketamine on the patient's vital signs."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Esketamine', 'Pain', 'Post-thoracotomy Pain Syndrome', 'Thoracic Diseases']}, 'referencesModule': {'references': [{'pmid': '39751970', 'type': 'DERIVED', 'citation': 'Wang H, Wang Z, Zhang J, Wang X, Fan B, He W, Hu X. Perioperative esketamine combined with butorphanol versus butorphanol alone for pain management following video-assisted lobectomy: a randomized controlled trial. Int J Clin Pharm. 2025 Apr;47(2):452-461. doi: 10.1007/s11096-024-01850-7. Epub 2025 Jan 3.'}]}, 'descriptionModule': {'briefSummary': 'Post-thoracotomy pain syndrome (PTPS) affects respiratory function, hindering sputum clearance and ventilation, and represents a significant complication of thoracic surgery. The analgesic effect of esketamine combined with butorphanol in PTPS is still unclear, so this study focused on this aspect.', 'detailedDescription': 'Post-thoracotomy pain syndrome affects respiratory function, hindering sputum clearance and ventilation, and represents a significant complication of thoracic surgery. Esketamine, the left-handed optical isomer of racemic ketamine, acts as an antagonist of the N-methyl-D-aspartate (NMDA) receptor, reversing central sensitization and improving postoperative pain. Butorphanol, an opioid receptor agonist-antagonist, can alleviate visceral pain, reduce the risk of respiratory depression, and decrease postoperative morphine consumption. However, research on the analgesic effects of esketamine combined with butorphanol in thoracoscopic surgery remains limited. Therefore, this study investigated the impact of esketamine combined with butorphanol on acute pain, chronic pain, and related side effects during the perioperative period in patients undergoing video-assisted lobectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 20-70 years\n* Classified as American Society of Anesthesiologists I-III\n* Undergoing video-assisted lobectomy\n\nExclusion Criteria:\n\n* Operative duration \\< 1 hour\n* Significant comorbidities affecting vital organs such as liver, kidney, and heart\n* Severe infections\n* Immunodeficiency\n* Coagulation disorders\n* History of analgesic drug abuse\n* Severe dementia or communication barriers\n* Mental illnesses.'}, 'identificationModule': {'nctId': 'NCT06398834', 'briefTitle': 'Esketamine and Butorphanol for Post-Lobectomy Pain', 'organization': {'class': 'OTHER', 'fullName': "Second People's Hospital of Hefei City"}, 'officialTitle': 'Effect of Esketamine Combined With Butorphanol on Pain Management Following Video-assisted Lobectomy', 'orgStudyIdInfo': {'id': '2022-keyan-007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group BK', 'description': 'Group BK received esketamine infusion at a rate of 0.3 mg/kg/h during surgery. Patients were provided with patient-controlled intravenous analgesia (PCIA) containing esketamine (1.5 mg/kg), butorphanol (0.15 mg/kg), and azasetron (20 mg) in a total volume of 100 ml within 48 hours after surgery.', 'interventionNames': ['Drug: Esketamine', 'Drug: Butorphanol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group B', 'description': 'Group B received an equivalent volume of saline during surgery. Patients were provided with patient-controlled intravenous analgesia (PCIA) containing butorphanol (0.15 mg/kg), and azasetron (20 mg) in a total volume of 100 ml within 48 hours after surgery.', 'interventionNames': ['Drug: Butorphanol']}], 'interventions': [{'name': 'Esketamine', 'type': 'DRUG', 'otherNames': ['S-Ketamine, (S)-2-(o-chlorophenyl)-2-(methylamino)cyclohexanone, L-Ketamine, (-)-Ketamine'], 'description': 'In the esketamine combined with butorphanol group (Group BK), patients received an intraoperative intravenous infusion of esketamine (0.3 mg/kg/h) followed by postoperative patient-controlled intravenous analgesia (PCIA) (esketamine 1.5 mg/kg + butorphanol 0.15 mg/kg + azasetron 20 mg).', 'armGroupLabels': ['Group BK']}, {'name': 'Butorphanol', 'type': 'DRUG', 'otherNames': ['Butorphanol Tartrate, Moradol, Stadol, Torbugesic, Apo-Butorphanol, Dolorex'], 'description': 'In the butorphanol group (Group B), patients received an equivalent volume of normal saline intraoperatively and postoperatively received PCIA without esketamine.', 'armGroupLabels': ['Group B', 'Group BK']}]}, 'contactsLocationsModule': {'locations': [{'zip': '230011', 'city': 'Hefei', 'state': 'Anhui', 'country': 'China', 'facility': "The Second People's Hospital of Hefei", 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}], 'overallOfficials': [{'name': 'Xianwen Hu, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'The Second Hospital of Anhui Medical University'}, {'name': 'Wensheng He, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': "The Second People's Hospital of Hefei"}, {'name': 'Xin Wang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "The Second People's Hospital of Hefei"}, {'name': 'Zicheng Wang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "The Second People's Hospital of Hefei"}, {'name': 'Junbao Zhang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "The Second People's Hospital of Hefei"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Second People's Hospital of Hefei City", 'class': 'OTHER'}, 'collaborators': [{'name': 'Tongji Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending doctor', 'investigatorFullName': 'Wang Hongjian', 'investigatorAffiliation': "Second People's Hospital of Hefei City"}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-05-20', 'type': 'RELEASE'}, {'date': '2024-05-21', 'type': 'UNRELEASE'}], 'unpostedResponsibleParty': "Wang Hongjian, Attending doctor, Second People's Hospital of Hefei City"}}}}