Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2026-02-07 @ 2:09 PM
Study NCT ID:
NCT03316066
Status:
WITHDRAWN
Last Update Posted:
2020-02-24
First Post:
2016-11-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Volumes of Local Anesthetics on the Efficiency and Safety of Stellate Ganglion Block for CRPS of the Arm
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020918', 'term': 'Complex Regional Pain Syndromes'}], 'ancestors': [{'id': 'D001342', 'term': 'Autonomic Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077212', 'term': 'Ropivacaine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Not able to recruit enough patients', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-02-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-21', 'studyFirstSubmitDate': '2016-11-22', 'studyFirstSubmitQcDate': '2017-10-18', 'lastUpdatePostDateStruct': {'date': '2020-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Occurrence of seizure during a stellate ganglion block', 'timeFrame': 'within 30 minutes of performing the stellate ganglion block', 'description': 'patient having seizure'}, {'measure': 'Occurrence of hematoma after a stellate ganglion block', 'timeFrame': 'During the first 7 days after the procedure', 'description': 'physician or patient identifying a neck hematoma'}, {'measure': 'Occurrence of pneumothorax after a stellate ganglion block', 'timeFrame': 'During the first 7 days after the procedure', 'description': 'physician diagnosing a pneumothorax'}], 'primaryOutcomes': [{'measure': 'Pain score', 'timeFrame': '24 hours after the stellate ganglion block', 'description': 'Evaluate the efficiency of stellate ganglion block in decreasing pain scores 24 hours after the procedure using a verbal numeric pain rating scale.'}], 'secondaryOutcomes': [{'measure': 'Pain score', 'timeFrame': '7 days after the stellate ganglion block', 'description': 'Evaluate the efficiency of stellate ganglion block in decreasing pain scores 7 days after the procedure using a verbal numeric pain rating scale.'}, {'measure': 'Pain score', 'timeFrame': '14 days after the stellate ganglion block', 'description': 'Evaluate the efficiency of stellate ganglion block in decreasing pain scores 14 days after the procedure using a verbal numeric pain rating scale.'}, {'measure': 'Temperature increase in the ipsilateral arm', 'timeFrame': '1 hour after the procedure', 'description': 'Evaluate the efficiency of stellate ganglion block on the increase in temperature of the ipsilateral arm using an infrared thermometer. The cutaneous temperature will be measured in order to determine the proportion of patients in each group reaching an increase of \\>1.5 C in the ipsilateral arm.'}, {'measure': 'Horner Syndrome', 'timeFrame': '1 hour after the procedure', 'description': 'Evaluate the efficiency of stellate ganglion block to produce an ipsilateral Horner Syndrome as defined by a ptosis and miosis. Evaluate the proportion of patients in each group presenting an ipsilateral Horner syndrome.'}, {'measure': 'Occurrence of dysphagia after a stellate ganglion block', 'timeFrame': '1 hour after the procedure', 'description': 'Patients describing having dysphagia after the stellate ganglion block'}, {'measure': 'Occurrence of hoarseness after a stellate ganglion block', 'timeFrame': '1 hour after the procedure', 'description': 'patients describing having hoarseness after a stellate ganglion block'}, {'measure': 'Occurrence of foreign body sensation after a stellate ganglion block', 'timeFrame': '1h after the procedure', 'description': 'patients describing having a foreign body sensation after the stellate ganglion block'}, {'measure': 'Occurrence of dyspnea after a stellate ganglion block', 'timeFrame': '1h after the procedure', 'description': 'patients describing having dyspnea after a stellate ganglion block'}, {'measure': 'Occurrence of ipsilateral arm weakness after a stellate ganglion block', 'timeFrame': '1h after the procedure', 'description': 'patients describing having ipsilateral arm weakness after a stellate ganglion block'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stellate Ganglion', 'Local Anesthetic'], 'conditions': ['Complex Regional Pain Syndromes']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the efficiency and safety of 2ml versus 5ml of local anesthetics used in stellate ganglion blocks for the treatment of complex regional pain syndrome of the arm.', 'detailedDescription': 'To evaluate if 2ml of 0.2% ropivacaine is less effective in decreasing pain scores by more than 50% when compared to 5ml of 0.2% ropivacaine. To evaluate if 2ml of 0.2% ropivacaine is causes less side effects when compared to 5ml after a stellate ganglion block.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a diagnosis of complex regional pain syndrome of the arm according to the Budapest criteria and having already received a minimum of 3 stellate ganglion blocks. Only patients having received a minimum of 3 stellate ganglion blocks will be included since it is expected to have a progressive and sustained decrease in pain scores during the first 3 blocks.\n* ASA 1 to 3 included\n\nExclusion Criteria:\n\n* Patient refusal\n* Contra-indications to the stellate ganglion block procedure such as coagulopathy, anticoagulants or anti platelet therapy other than aspirin, systemic or injection site infection, important neck deformity (post-radiotherapy or surgery, etc.), severe chronic obstructive pulmonary disease, contralateral diaphragm paralysis or contralateral pneumonectomy\n* Allergy to local anesthetics\n* Concomitant pain syndrome other than complex regional pain syndrome of the arm\n* Liver or kidney failure (CrCl \\< 30 ml/min)\n* Inability to understand à verbal numeric pain score scale after careful explanations\n* Inability to consent'}, 'identificationModule': {'nctId': 'NCT03316066', 'briefTitle': 'Comparison of Volumes of Local Anesthetics on the Efficiency and Safety of Stellate Ganglion Block for CRPS of the Arm', 'organization': {'class': 'OTHER', 'fullName': 'Maisonneuve-Rosemont Hospital'}, 'officialTitle': 'Comparison of Two Volumes of Local Anesthetics on the Efficiency and Safety of Stellate Ganglion Block for the Treatment of Complex Regional Pain Syndrome of the Arm', 'orgStudyIdInfo': {'id': 'Maisonneuve RH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 5', 'description': 'stellate ganglion block with ropivacaine 0.2% 5 mL', 'interventionNames': ['Procedure: stellate ganglion block with ropivacaine 0.2% 5 mL']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'description': 'stellate ganglion block wit ropivacaine 0.2% 2 mL', 'interventionNames': ['Procedure: stellate ganglion block wit ropivacaine 0.2% 2 mL']}], 'interventions': [{'name': 'stellate ganglion block with ropivacaine 0.2% 5 mL', 'type': 'PROCEDURE', 'description': 'Each patient will undergo two stellate ganglion blocks and receive both volumes of local anesthetics in random order. The stellate ganglion blocks will be separated by 3 weeks in order to assure that no residual effects from the previous block will influence the results.', 'armGroupLabels': ['Group 5']}, {'name': 'stellate ganglion block wit ropivacaine 0.2% 2 mL', 'type': 'PROCEDURE', 'description': 'Each patient will undergo two stellate ganglion blocks and receive both volumes of local anesthetics in random order. The stellate ganglion blocks will be separated by 3 weeks in order to assure that no residual effects from the previous block will influence the results.', 'armGroupLabels': ['Group 2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Veronique Brulotte, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maisonneuve-Rosemont Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maisonneuve-Rosemont Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, MSc, FRCPC', 'investigatorFullName': 'Veronique Brulotte', 'investigatorAffiliation': 'Maisonneuve-Rosemont Hospital'}}}}