Ignite Creation Date:
2025-12-24 @ 5:14 PM
Ignite Modification Date:
2025-12-30 @ 6:37 AM
Study NCT ID:
NCT01711450
Status:
WITHDRAWN
Last Update Posted:
2016-03-23
First Post:
2012-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Success of Paravertebral Blocks in Analgesia for Interventional Hepatic Procedures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008113', 'term': 'Liver Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Institutional Ethics Board concern regarding sham procedure, requiring modifications that are not feasible within the man-power limitations of our institution.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-22', 'studyFirstSubmitDate': '2012-10-18', 'studyFirstSubmitQcDate': '2012-10-18', 'lastUpdatePostDateStruct': {'date': '2016-03-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose of intravenous sedation required during and after the procedure', 'timeFrame': '1 hour'}], 'secondaryOutcomes': [{'measure': 'Improvement in analogue pain scoring after the procedure', 'timeFrame': '1 hour'}, {'measure': 'Procedure duration', 'timeFrame': '1 hour'}, {'measure': 'Complication rate of liver procedure', 'timeFrame': '24 hours'}, {'measure': 'Complication rate of paravertebral block', 'timeFrame': '1 hour'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Liver Neoplasms']}, 'descriptionModule': {'briefSummary': 'This study is aimed at assessing whether performing a paravertebral block (a type of regional pain relief) can reduce the pain and anxiety patients experience during radiological procedures on the liver.', 'detailedDescription': 'Percutaneous procedures of the liver can be very painful and range from bliliary drain insertions to tumor ablation procedures. The study will randomize patients in two groups, one receiving a paravertebral nerve block prior to the procedure and one receiving a sham procedure in which saline will be injected in the paravertebral space. Pain scores and use of IV sedation will be monitored post procedure and both groups will be compared to assess whether paravetebral nerve blocks are effective at reducing pain in patients receiving such procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or non-pregnant female subjects, between the ages of 18 and 80 at the time of enrollment.\n\nSubjects referred for liver/biliary interventions to the angiography department.\n\nWritten informed consent to participate in the study. Ability to comply with the requirements of the study procedures\n\nExclusion Criteria:\n\n* Subjects who participated in an active stage of any drug, intervention or treatment trial within 30 days of enrollment.\n\nSubjects with preexisting conditions, which, in the opinion of the investigator, interfere with the conduct of the study. Patients will only be excluded on this basis following discussion with another interventional radiologist.\n\nSubjects who are uncooperative or cannot follow instructions. Mental state that may preclude completion of the study procedure or ability to obtain informed consent.\n\nPregnant or nursing female subjects. Patient who are to undergo liver biopsy or routine biliary tube exchange. Patients with neurological/spinal conditions, or a BMI over 40, that would prevent safe/effective or well-targeted paravertebral blockade.\n\nPatient unable to tolerate the paravertebral block procedure, for example due to inability to lie prone'}, 'identificationModule': {'nctId': 'NCT01711450', 'briefTitle': 'Success of Paravertebral Blocks in Analgesia for Interventional Hepatic Procedures', 'organization': {'class': 'OTHER', 'fullName': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}, 'officialTitle': 'Randomised Double Blind Controlled Study of the Effectiveness of Paravertebral Nerve Block in Decreasing Analgesia Requirements and Improving Patient Experience During Interventional Hepatic Procedures.', 'orgStudyIdInfo': {'id': '12-263-SDR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Paravertebral block', 'description': 'Paravertebral space will be needled and an anesthetic agent will be injected.', 'interventionNames': ['Procedure: Paravertebral block']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control sham procedure', 'description': 'Paravertebral space will be needled, but only normal saline injected.', 'interventionNames': ['Procedure: Control sham procedure']}], 'interventions': [{'name': 'Paravertebral block', 'type': 'PROCEDURE', 'description': 'Injection of local anaesthesia into paravertebral space to provide analgesia', 'armGroupLabels': ['Paravertebral block']}, {'name': 'Control sham procedure', 'type': 'PROCEDURE', 'description': 'Injection of Normal saline into the paravertebral space', 'armGroupLabels': ['Control sham procedure']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3A 1A1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Royal Victoria Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H3G 1A4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Montreal General Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Richard Lindsay, MB Bch', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}, {'name': 'Louis Boucher, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Richard Lindsay', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Richard Lindsay', 'investigatorAffiliation': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}}}}