Ignite Creation Date:
2025-12-24 @ 3:37 PM
Ignite Modification Date:
2025-12-28 @ 10:51 AM
Study NCT ID:
NCT05211492
Status:
TERMINATED
Last Update Posted:
2025-12-18
First Post:
2021-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute and Chronic Pain After One-stage Hybrid Arrhythmia Ablation Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D059787', 'term': 'Acute Pain'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'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': 'D011183', 'term': 'Postoperative Complications'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'There are 3 groups. 1 chronic pain, 2 acute pain, 3 no pain'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'whyStopped': 'not enough patients were recruited', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2021-12-22', 'studyFirstSubmitQcDate': '2022-01-26', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with acute pain after one stage hybrid ablation.', 'timeFrame': '3 months postop', 'description': 'How many patients have acute pain after surgery'}, {'measure': 'Number of patients with chronic pain after one stage hybrid ablation.', 'timeFrame': '3 months postop', 'description': 'How many patients have acute pain after surgery'}], 'secondaryOutcomes': [{'measure': 'Intensity of immediate pain following one stage hybrid ablation', 'timeFrame': '3 days', 'description': 'How painful on a numeric pain scale rating of 0 to 10 is the immediate pain post operation? 10 being the worst pain ever felt and 0 being totally painfree.'}, {'measure': 'Duration of immediate pain following one stage hybrid ablation', 'timeFrame': '3 days', 'description': 'How long does the immediate pain post operation last?'}, {'measure': 'Intensity of acute and chronic pain after receiving an advance anesthesiologic pain block.', 'timeFrame': '3 months', 'description': 'How painful on a numeric pain scale rating of 0 to 10 is the acute or chronic pain post operation? 10 being the worst pain ever felt and 0 being totally pain free.'}, {'measure': 'Intensity of acute and chronic pain after administration of ketamine.', 'timeFrame': '3 months', 'description': 'How painful on a numeric pain scale rating of 0 to 10 is the acute or chronic pain post operation? 10 being the worst pain ever felt and 0 being totally pain free.'}, {'measure': 'Intensity of acute and chronic pain after treatment with opioids.', 'timeFrame': '3 months', 'description': 'How painful on a numeric pain scale rating of 0 to 10 is the acute or chronic pain post operation? 10 being the worst pain ever felt and 0 being totally pain free.'}, {'measure': 'Intensity of acute and chronic pain after placing of a thorax drain post operatively.', 'timeFrame': '3 months', 'description': 'How painful on a numeric pain scale rating of 0 to 10 is the acute or chronic pain post operation? 10 being the worst pain ever felt and 0 being totally pain free.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Arrythmia', 'Chronic Pain', 'Acute Pain', 'Post Operative Pain']}, 'descriptionModule': {'briefSummary': 'After one-stage hybrid arrhythmia ablation surgery there are possible side effects like acute and chronic pain. There is a lot of research surrounding these pains but not specifically after one-stage hybrid arrhythmia ablation surgery. The investigators want to research factors that may be associated with the absence of chronic pain after hybrid ablation include ketamine, peroperative opioids, loco-regional blocks, neuraxial blocks, wound infiltration, postoperative patient-controlled analgesia. The presence of corticosteroids or NSAIDS, will also be evaluated. Furthermore, non-adaptable factors such as genetics complicate the onset of chronic post-operative pain. Taking existing knowledge in this field into account, incidence risk as well as acute pain duration and intensity and their effects on chronic pain will become the primary focus of this study.\n\nThe investigators will contact all patients who had a one-stage hybrid arrhythmia ablation surgery at UZ Brussels. Participants will be sent a questionnaire with a consent form in and a survey asking about their pain 3 months postop and their current pain management therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* he/she must understand and read the Dutch, French or English language\n* be able to digitally agree to participate in the study\n* had to have a one stage hybrid procedure at least three months ago\n* have an ASA score of I, II or III.\n\nExclusion Criteria:\n\n* Patients with previously known chronic pain syndromes, fibromyalgia, complex regional pain syndrome are excluded.\n* Subjects with previous known chronic conditions such as diabetes neuropathy, rheumatoid arthri-tis, … are also excluded.\n* Subject are excluded if they underwent a surgical treatment within the observed period.\n* Patients are excluded when under treatment with chemotherapy/radiotherapy\n* Pregnant patients are also excluded.\n* Patients with known psychological conditions such as depression are excluded.'}, 'identificationModule': {'nctId': 'NCT05211492', 'briefTitle': 'Acute and Chronic Pain After One-stage Hybrid Arrhythmia Ablation Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Universitair Ziekenhuis Brussel'}, 'officialTitle': 'Acute and Chronic Pain After One-stage Hybrid Arrhythmia Ablation Surgery: A Study on the Presence of Chronic Pain After Hybrid Ablation and Factors That May be Associated', 'orgStudyIdInfo': {'id': 'Pain 1StageHybride Ablation'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Chronic pain', 'interventionNames': ['Other: Questionnaire']}, {'type': 'OTHER', 'label': 'Acute pain', 'interventionNames': ['Other: Questionnaire']}, {'type': 'OTHER', 'label': 'Control group', 'interventionNames': ['Other: Questionnaire']}], 'interventions': [{'name': 'Questionnaire', 'type': 'OTHER', 'description': 'Patients are asked to fill in an online questionnaire concerning their postoperative pain.', 'armGroupLabels': ['Acute pain', 'Chronic pain', 'Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Jette', 'state': 'Brussels Capital', 'country': 'Belgium', 'facility': 'UZ Brussel', 'geoPoint': {'lat': 50.87309, 'lon': 4.33419}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitair Ziekenhuis Brussel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}