Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-25 @ 8:07 PM
Study NCT ID:
NCT01472835
Status:
COMPLETED
Last Update Posted:
2016-12-15
First Post:
2011-04-25
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Effect of Sedation on Diagnostic Injections
Sponsor:
Organization:
Raw JSON
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Since this is a crossover trial, patients will receive both "treatments".\n\nSympathetic block: Sympathetic block with bupivacaine\n\nbupivacaine\n\ncorticosteroid', 'otherNumAtRisk': 37, 'otherNumAffected': 3, 'seriousNumAtRisk': 37, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'Patient did not receive sedation during procedure', 'otherNumAtRisk': 36, 'otherNumAffected': 6, 'seriousNumAtRisk': 36, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'notes': 'Less than 1 day', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'dysphagia', 'notes': 'Less than 1 day', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'notes': 'Less than 1 day', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Worse pain', 'notes': 'Less than 1 week', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Weakness', 'notes': 'Less than 1 day', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'notes': 'Less than 1 day', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sedation', 'description': 'Pt will receive sedation with their 1st procedure and no sedation with their 2nd procedure\n\nsacroiliac joint injection: Patient will receive an injection into the sacroiliac joint with bupivacaine and corticosteroid with and without sedation. Since this is a crossover trial, patients will receive both "treatments".\n\nSympathetic block: Sympathetic block with bupivacaine\n\nbupivacaine\n\ncorticosteroid'}, {'id': 'OG001', 'title': 'Control', 'description': 'Patient will not receive sedation during their 1st procedure but receive sedation during their 2nd procedure'}], 'classes': [{'categories': [{'measurements': [{'value': '2.2', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '2.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'through 6 hours after injection', 'description': 'pain diary using 0-10 scale, with 0 being no pain and 10 being the worst pain imaginable', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sedation', 'description': 'Pt will receive sedation with their procedure\n\nsacroiliac joint injection: Patient will receive an injection into the sacroiliac joint with bupivacaine and corticosteroid with and without sedation. Since this is a crossover trial, patients will receive both "treatments".\n\nSympathetic block: Sympathetic block with bupivacaine\n\nbupivacaine\n\ncorticosteroid'}, {'id': 'OG001', 'title': 'Control', 'description': 'Patient will not receive sedation during procedure'}], 'classes': [{'categories': [{'measurements': [{'value': '5.1', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '5.6', 'spread': '2.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1-month', 'description': '0-10 numerical rating scale (NRS) pain scale. 0 being no pain and 10 being the worst possible pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Procedure-related Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sedation', 'description': 'Pt will receive sedation with their 1st procedure and no sedation with their 2nd procedure\n\nsacroiliac joint injection: Patient will receive an injection into the sacroiliac joint with bupivacaine and corticosteroid with and without sedation. Since this is a crossover trial, patients will receive both "treatments".\n\nSympathetic block: Sympathetic block with bupivacaine\n\nbupivacaine\n\ncorticosteroid'}, {'id': 'OG001', 'title': 'Control', 'description': 'Patient will not receive sedation during the 1st procedure, but receive sedation during their 2nd procedure'}], 'classes': [{'categories': [{'measurements': [{'value': '3.1', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '5.5', 'spread': '2.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day', 'description': '0-10 pain scale, with 0 being no pain and 10 being the worst pain imaginable', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Oswestry Disability Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sedation', 'description': 'Pt will receive sedation with their procedure\n\nsacroiliac joint injection: Patient will receive an injection into the sacroiliac joint with bupivacaine and corticosteroid with and without sedation. Since this is a crossover trial, patients will receive both "treatments".\n\nSympathetic block: Sympathetic block with bupivacaine\n\nbupivacaine\n\ncorticosteroid'}, {'id': 'OG001', 'title': 'Control', 'description': 'Patient will not receive sedation during procedure'}], 'classes': [{'categories': [{'measurements': [{'value': '34.8', 'spread': '14.6', 'groupId': 'OG000'}, {'value': '40.6', 'spread': '17.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1-month', 'description': 'Measure of functional capacity on a scale ranging from 0% to 100%, with 0% signifying no disability', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sedation', 'description': 'Pt will receive sedation with their procedure\n\nsacroiliac joint injection: Patient will receive an injection into the sacroiliac joint with bupivacaine and corticosteroid with and without sedation. Since this is a crossover trial, patients will receive both "treatments".\n\nSympathetic block: Sympathetic block with bupivacaine\n\nbupivacaine\n\ncorticosteroid'}, {'id': 'OG001', 'title': 'Control', 'description': 'Patient will not receive sedation during procedure'}], 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '1.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day', 'description': '5-point Likert scale. The scale is from 1-5. 1 being very unsatisfied and 5 being very satisfied.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sedation', 'description': 'Pt will receive sedation with their 1st procedure, then a control procedure will be done without sedation\n\nsacroiliac joint injection: Patient will receive an injection into the sacroiliac joint with bupivacaine and corticosteroid with and without sedation. Since this is a crossover trial, patients will receive both "treatments".\n\nSympathetic block: Sympathetic block with bupivacaine\n\nbupivacaine\n\ncorticosteroid'}, {'id': 'FG001', 'title': 'Control', 'description': 'Patient will not receive sedation during their 1st procedure, but receive sedation during the 2nd procedure'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sedation', 'description': 'Pt will receive sedation with their 1st procedure and no sedation with their 2nd procedure\n\nsacroiliac joint injection: Patient will receive an injection into the sacroiliac joint with bupivacaine and corticosteroid with and without sedation. Since this is a crossover trial, patients will receive both "treatments".\n\nSympathetic block: Sympathetic block with bupivacaine\n\nbupivacaine\n\ncorticosteroid'}, {'id': 'BG001', 'title': 'Control', 'description': 'Patient will not receive no sedation during their 1st procedure and sedation during their 2nd procedure'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.7', 'spread': '16.1', 'groupId': 'BG000'}, {'value': '50.3', 'spread': '13.8', 'groupId': 'BG001'}, {'value': '50.0', 'spread': '15.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 73}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-31', 'studyFirstSubmitDate': '2011-04-25', 'resultsFirstSubmitDate': '2014-03-19', 'studyFirstSubmitQcDate': '2011-11-16', 'lastUpdatePostDateStruct': {'date': '2016-12-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-05-19', 'studyFirstPostDateStruct': {'date': '2011-11-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Score', 'timeFrame': 'through 6 hours after injection', 'description': 'pain diary using 0-10 scale, with 0 being no pain and 10 being the worst pain imaginable'}], 'secondaryOutcomes': [{'measure': 'Pain Score', 'timeFrame': '1-month', 'description': '0-10 numerical rating scale (NRS) pain scale. 0 being no pain and 10 being the worst possible pain.'}, {'measure': 'Procedure-related Pain Score', 'timeFrame': '1 day', 'description': '0-10 pain scale, with 0 being no pain and 10 being the worst pain imaginable'}, {'measure': 'Oswestry Disability Index', 'timeFrame': '1-month', 'description': 'Measure of functional capacity on a scale ranging from 0% to 100%, with 0% signifying no disability'}, {'measure': 'Satisfaction', 'timeFrame': '1 day', 'description': '5-point Likert scale. The scale is from 1-5. 1 being very unsatisfied and 5 being very satisfied.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['sedation', 'sensitivity', 'specificity', 'validity', 'diagnostic injection'], 'conditions': ['Sacroiliac Joint Pain', 'Sympathetically Maintained Pain']}, 'referencesModule': {'references': [{'pmid': '18042881', 'type': 'BACKGROUND', 'citation': 'Cohen SP, Hurley RW. The ability of diagnostic spinal injections to predict surgical outcomes. Anesth Analg. 2007 Dec;105(6):1756-75, table of contents. doi: 10.1213/01.ane.0000287637.30163.a2.'}, {'pmid': '24524866', 'type': 'DERIVED', 'citation': 'Cohen SP, Hameed H, Kurihara C, Pasquina PF, Patel AM, Babade M, Griffith SR, Erdek ME, Jamison DE, Hurley RW. The effect of sedation on the accuracy and treatment outcomes for diagnostic injections: a randomized, controlled, crossover study. Pain Med. 2014 Apr;15(4):588-602. doi: 10.1111/pme.12389. Epub 2014 Feb 13.'}]}, 'descriptionModule': {'briefSummary': 'Interventional pain procedures have diagnostic, prognostic and therapeutic value. It is well-documented that the reference standard for identifying a pain generator is a low-volume block performed with local anesthetic, with or without steroid. Many factors may increase the false positive (FP) rate of diagnostic and prognostic nerve blocks; however, the use of sedation is the most controversial and remediable. Proponents of sedation argue that it has little effect on the rate of positive diagnostic blocks, and may even reduce the false-negative rate. The purpose of this study is to determine the effect of intravenous sedation on pain relief and the "false-positive rate" after diagnostic nerve blocks.', 'detailedDescription': 'Sixty-eight patients with sacroiliac (SI) joint or sympathetically-maintained pain will be randomized in a crossover fashion to receive diagnostic nerve blocks either with or without intravenous sedation. Among those who obtain some benefit and return for a 2nd block, this 2nd procedure will be done with sedation if the first was done without sedation, and vice versa. Midazolam and fentanyl will be used for intravenous sedation, titrated to anxiolysis and analgesia. Pain scores (0-10 numerical rating scale, or NRS) and an activity log will be recorded over the 8-hours following the blocks via a pain diary. The first follow-up visit will be 4 weeks after the procedure. Patients who obtain some benefit but continue to report significant pain or who might otherwise benefit from a repeat procedure will have this second procedure performed with sedation if no sedation was given for the first procedure, and without sedation if sedation was administered for the first procedure. The post-procedure pain data will be recorded in the same fashion as the initial nerve block. The second follow-up visit will be 4 weeks after the 2nd block.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic pain \\> 4 weeks but \\< 10 years in duration\n* Suspected SI joint or sympathetically-maintained pain based on history and physical exam\n* May benefit from a sacroiliac joint or sympathetic block\n* Pain on 0-10 NRS scale \\> 3/10 in intensity\n\nExclusion Criteria:\n\n* No previous interventional pain-alleviating injections for the same condition within the past 3 years\n* Uncontrolled coagulopathy\n* Pregnancy, which will be ruled out by a urine pregnancy test in women of childbearing age\n* Allergy to contrast dye or amide local anesthetics\n* Unstable medical or psychiatric condition (e.g. unstable angina, congestive heart failure or severe depression) that could preclude an optimal treatment response\n* Systemic infection\n* Age \\< 18 or \\> 75 years'}, 'identificationModule': {'nctId': 'NCT01472835', 'briefTitle': 'Effect of Sedation on Diagnostic Injections', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Randomized, Cross-over Study Evaluating the Effect of Sedation on Pain Relief After Diagnostic Injections', 'orgStudyIdInfo': {'id': 'NA_00045905'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sedation', 'description': 'Pt will receive sedation with their procedure', 'interventionNames': ['Drug: Midazolam', 'Drug: Fentanyl']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Patient will not receive sedation during procedure'}], 'interventions': [{'name': 'Midazolam', 'type': 'DRUG', 'description': 'Used for anxiolysis', 'armGroupLabels': ['Sedation']}, {'name': 'Fentanyl', 'type': 'DRUG', 'description': 'Used for analgesia and as a sedative', 'armGroupLabels': ['Sedation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Blaustein Pain Treatment Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Steven P Cohen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Walter Reed National Military Medical Center', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Steven P. Cohen', 'investigatorAffiliation': 'Johns Hopkins University'}}}}