Ignite Creation Date:
2025-12-24 @ 4:59 PM
Ignite Modification Date:
2026-02-22 @ 9:15 PM
Study NCT ID:
NCT04633850
Status:
COMPLETED
Last Update Posted:
2021-07-01
First Post:
2020-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implementation of Adjuvants in Intercostal Nerve Blockades for Thoracoscopic Surgery in Pulmonary Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'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'}, {'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': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-28', 'studyFirstSubmitDate': '2020-11-03', 'studyFirstSubmitQcDate': '2020-11-11', 'lastUpdatePostDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total equipotent dose of opioids', 'timeFrame': '24 hours', 'description': 'Sum of equipotent opioid doses during the first 24 hours after surgery'}], 'secondaryOutcomes': [{'measure': 'Time to first administration of opioids after surgery', 'timeFrame': '48 hours', 'description': 'In hours and minuts'}, {'measure': 'Numerical rating scale score', 'timeFrame': '24 hours', 'description': 'Pain score reported by the patient after surgery from 0 (no pain) to 10 (worst imaginable pain) in whole numbers.'}, {'measure': 'Time for full mobilization', 'timeFrame': 'Through study completion, an average of 1 week', 'description': 'The total time for full mobilization (walk with support)'}, {'measure': 'Total dose of non-opioid analgesics', 'timeFrame': '24 hours', 'description': 'Sum of non-opioid doses during the first 24 hours after surgery'}, {'measure': 'The need for pain medication at discharge', 'timeFrame': 'At discharge from hospital, an average of 1 week', 'description': 'The need for pain medication at discharge (all forms, type, dose)'}, {'measure': 'Postoperative complication (Empyema)', 'timeFrame': 'At discharge from hospital, an average of 1 week', 'description': 'Empyema (yes/no) as complication to the surgery described in the patients journal at discharge (epicrisis)'}, {'measure': 'Postoperative complication (Air leakage)', 'timeFrame': 'At discharge from hospital, an average of 1 week', 'description': 'Air leakage (yes/no) as complication to the surgery described in the patients journal at discharge (epicrisis)'}, {'measure': 'Postoperative complication (Reoperation)', 'timeFrame': 'At discharge from hospital, an average of 1 week', 'description': 'Reoperation (yes/no) as complication to the surgery described in the patients journal at discharge (epicrisis)'}, {'measure': 'Postoperative complication (Pneumonia)', 'timeFrame': 'At discharge from hospital, an average of 1 week', 'description': 'Pneumonia (yes/no) as complication to the surgery described in the patients journal at discharge (epicrisis)'}, {'measure': 'Postoperative complication (Drainage of pleural effusion)', 'timeFrame': 'At discharge from hospital, an average of 1 week', 'description': 'Pleural effusion (yes/no) as complication to the surgery described in the patients journal at discharge (epicrisis)'}, {'measure': 'Postoperative complication (Oyxgen therapy)', 'timeFrame': 'At discharge from hospital, an average of 1 week', 'description': 'The need for supplemental oxygen therapy and need for mechanical ventilation (yes/no) as complication to the surgery described in the patients journal at discharge (epicrisis)'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Pain', 'Lung Cancer', 'Video Assisted Thoracoscopic Surgery', 'Thoracoscopic Surgery', 'Nerve Block', 'Local Anesthesia']}, 'referencesModule': {'references': [{'pmid': '38445317', 'type': 'DERIVED', 'citation': 'Lobel J, Danielsen AV, Sperling PK, Bisgaard J. Intravenous dexamethasone in pain treatment after video-assisted thoracoscopic surgery. Dan Med J. 2024 Feb 12;71(3):A05230317. doi: 10.61409/A05230317.'}]}, 'descriptionModule': {'briefSummary': 'To investigate the effect of intercostal blockade with and without adjuvants.', 'detailedDescription': "Video-assisted thoracoscopic surgery (VATS) is a minimally invasive routine procedure. It's less invasive than thoracotomy but postoperative pain is still a problem.\n\nAt Aalborg University Hospital, intercostal blockades with bupivacaine is used as standard pain treatment for patients undergoing VATS. Adding adjuvants to the blockades may prolong the effect.\n\nThe aim of this study is to investigate if intercostal nerve blockade with adjuvants (intravenous (IV) dexamethasone) will result in better pain management.\n\nThe primary plan was to evaluate the effect of adding IV dexamethasone and perineural adrenaline, but due to adverse effects, adrenaline was first reduced and later removed from the intervention (amendment protocol N-20200040 approved by the Ethics Committee of Northern Jutland on February 2nd 2021)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult lung cancer patients scheduled to undergo VATS at Aalborg University Hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n° Consecutive adult patients over 18 years of age scheduled to undergo VATS because of verified/suspected lung cancer.\n\nExclusion Criteria:\n\n* Inability to understand verbal and written information.\n* Preexisting chronic pain condition.\n* Preoperative daily treatment with pain medication (Non-opioids, opioids, gabapentin/pregabalin).\n* Previous thoracic surgery.\n* Previous chemotherapy due to thoracic malignancy and / or radiation therapy. to the thorax.\n* Pregnant women.\n* Autoimmune neuromuscular diseases (sclerosis, peripheral neuromuscular disorders). General muscle weakness or atrophy.\n* Hypersensitivity, allergy or intolerance to dexamethasone, bupivacaine or adrenaline.\n* Preoperative epidural anaesthesia.'}, 'identificationModule': {'nctId': 'NCT04633850', 'briefTitle': 'Implementation of Adjuvants in Intercostal Nerve Blockades for Thoracoscopic Surgery in Pulmonary Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Aalborg University Hospital'}, 'officialTitle': 'Implementation of Adjuvants in Intercostal Nerve Blockades for Thoracoscopic Surgery in Pulmonary Cancer Patients: A Before and After Study', 'orgStudyIdInfo': {'id': 'Smerter efter VATS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Before implementation', 'description': 'Perineural bupivacaine without adjuvants.', 'interventionNames': ['Drug: Bupivacain']}, {'label': 'After implementation', 'description': 'Perineural bupivacaine with intravenous dexamethasone.', 'interventionNames': ['Drug: Dexamethasone']}], 'interventions': [{'name': 'Dexamethasone', 'type': 'DRUG', 'description': 'Intravenous dexamethasone 8 mg. Given once at the end of surgery.', 'armGroupLabels': ['After implementation']}, {'name': 'Bupivacain', 'type': 'DRUG', 'description': 'Bupivacaine dose according to weight. \\<60 kg: Total dose 100mg 60-90kg: Total dose 150mg \\>90kg: Total dose 200mg\n\nGiven once at the end of surgery.', 'armGroupLabels': ['Before implementation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Aalborg', 'state': 'Region of Northern Jutland', 'country': 'Denmark', 'facility': 'Aalborg University Hospital', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}], 'overallOfficials': [{'name': 'Jannie Bisgaard Stæhr, PhD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anaesthesia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jannie Bisgaard Stæhr', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD PhD', 'investigatorFullName': 'Jannie Bisgaard Stæhr', 'investigatorAffiliation': 'Aalborg University Hospital'}}}}