Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2026-01-25 @ 1:49 AM
Study NCT ID:
NCT02506660
Status:
COMPLETED
Last Update Posted:
2018-08-29
First Post:
2015-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Interscalene Block With Low-dose IV vs. Perineural Dexamethasone for Shoulder Arthroscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'KahnR@HSS.EDU', 'phone': '212-774-7274', 'title': 'Dr. Richard Kahn', 'organization': 'Hospital of Special Surgery'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Intravenous Dexamethasone', 'description': 'Patients will receive 1 cc (1 mg) dexamethasone intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc saline.\n\nBupivacaine\n\nIntravenous dexamethasone\n\nPerineural saline: Saline in nerve block', 'otherNumAtRisk': 62, 'otherNumAffected': 0, 'seriousNumAtRisk': 62, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Perineural Dexamethasone', 'description': 'Patients will receive 1 cc saline intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc (1 mg) dexamethasone.\n\nBupivacaine\n\nPerineural dexamethasone: Dexamethasone in nerve block\n\nIntravenous saline', 'otherNumAtRisk': 63, 'otherNumAffected': 0, 'seriousNumAtRisk': 63, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Nerve Block Duration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intravenous Dexamethasone', 'description': 'Patients will receive 1 cc (1 mg) dexamethasone intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc saline.\n\nBupivacaine\n\nIntravenous dexamethasone\n\nPerineural saline: Saline in nerve block'}, {'id': 'OG001', 'title': 'Perineural Dexamethasone', 'description': 'Patients will receive 1 cc saline intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc (1 mg) dexamethasone.\n\nBupivacaine\n\nPerineural dexamethasone: Dexamethasone in nerve block\n\nIntravenous saline'}], 'classes': [{'categories': [{'measurements': [{'value': '22.2', 'groupId': 'OG000', 'lowerLimit': '19.5', 'upperLimit': '26'}, {'value': '25.7', 'groupId': 'OG001', 'lowerLimit': '22.2', 'upperLimit': '31.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Postoperative day 2+', 'description': 'Time at which the pain relief from the block has completely worn off', 'unitOfMeasure': 'Hours', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Numerical Rating Scale Pain Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intravenous Dexamethasone', 'description': 'Patients will receive 1 cc (1 mg) dexamethasone intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc saline.\n\nBupivacaine\n\nIntravenous dexamethasone\n\nPerineural saline: Saline in nerve block'}, {'id': 'OG001', 'title': 'Perineural Dexamethasone', 'description': 'Patients will receive 1 cc saline intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc (1 mg) dexamethasone.\n\nBupivacaine\n\nPerineural dexamethasone: Dexamethasone in nerve block\n\nIntravenous saline'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Duration of stay in recovery room after surgery (average of 3 hours)', 'description': 'The 11-point numeric scale ranges from \'0\' representing one pain extreme (e.g. "no pain") to \'10\' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Opioid Consumption', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intravenous Dexamethasone', 'description': 'Patients will receive 1 cc (1 mg) dexamethasone intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc saline.\n\nBupivacaine\n\nIntravenous dexamethasone\n\nPerineural saline: Saline in nerve block'}, {'id': 'OG001', 'title': 'Perineural Dexamethasone', 'description': 'Patients will receive 1 cc saline intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc (1 mg) dexamethasone.\n\nBupivacaine\n\nPerineural dexamethasone: Dexamethasone in nerve block\n\nIntravenous saline'}], 'classes': [{'title': 'Postoperative day 2', 'categories': [{'measurements': [{'value': '67.3', 'spread': '55.7', 'groupId': 'OG000'}, {'value': '67.4', 'spread': '51', 'groupId': 'OG001'}]}]}, {'title': 'postoperative day 3', 'categories': [{'measurements': [{'value': '33', 'spread': '48.6', 'groupId': 'OG000'}, {'value': '39.7', 'spread': '55.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Postoperative day 2, postoperative day 3', 'unitOfMeasure': 'mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Side Effects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intravenous Dexamethasone', 'description': 'Patients will receive 1 cc (1 mg) dexamethasone intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc saline.\n\nBupivacaine\n\nIntravenous dexamethasone\n\nPerineural saline: Saline in nerve block'}, {'id': 'OG001', 'title': 'Perineural Dexamethasone', 'description': 'Patients will receive 1 cc saline intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc (1 mg) dexamethasone.\n\nBupivacaine\n\nPerineural dexamethasone: Dexamethasone in nerve block\n\nIntravenous saline'}], 'classes': [{'title': 'Postoperative day 2', 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'postoperative day 3', 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Postoperative day 2, postoperative day 3', 'description': 'Opioid-related symptom distress scale is calculated using responses to the symptom severity questions only.\n\nFor each symptom, severity is assessed by the question: "(If yes), how severe was it usually?" (In the past 24 hours) The responses to the severity questions are measured on a 5-point scale from 0-4 in ascending order as follows: Did not have symptom (0) Slight (1) Moderate (2) Severe (3) Very severe (4)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Block Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intravenous Dexamethasone', 'description': 'Patients will receive 1 cc (1 mg) dexamethasone intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc saline.\n\nBupivacaine\n\nIntravenous dexamethasone\n\nPerineural saline: Saline in nerve block'}, {'id': 'OG001', 'title': 'Perineural Dexamethasone', 'description': 'Patients will receive 1 cc saline intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc (1 mg) dexamethasone.\n\nBupivacaine\n\nPerineural dexamethasone: Dexamethasone in nerve block\n\nIntravenous saline'}], 'classes': [{'title': 'postoperative day 2', 'categories': [{'measurements': [{'value': '8.1', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '8.1', 'spread': '2.2', 'groupId': 'OG001'}]}]}, {'title': 'postoperative day 3', 'categories': [{'measurements': [{'value': '8.0', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '7.5', 'spread': '2.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Postoperative day 2, postoperative day 3', 'description': '0-10 scale (0=not satisfied; 10=extremely satisfied)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Block-related Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intravenous Dexamethasone', 'description': 'Patients will receive 1 cc (1 mg) dexamethasone intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc saline.\n\nBupivacaine\n\nIntravenous dexamethasone\n\nPerineural saline: Saline in nerve block'}, {'id': 'OG001', 'title': 'Perineural Dexamethasone', 'description': 'Patients will receive 1 cc saline intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc (1 mg) dexamethasone.\n\nBupivacaine\n\nPerineural dexamethasone: Dexamethasone in nerve block\n\nIntravenous saline'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Postoperative day 7-10', 'unitOfMeasure': 'patients with block complications', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '% of Participants Who Guessed the Correct Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intravenous Dexamethasone', 'description': 'Patients will receive 1 cc (1 mg) dexamethasone intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc saline.\n\nBupivacaine\n\nIntravenous dexamethasone\n\nPerineural saline: Saline in nerve block'}, {'id': 'OG001', 'title': 'Perineural Dexamethasone', 'description': 'Patients will receive 1 cc saline intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc (1 mg) dexamethasone.\n\nBupivacaine\n\nPerineural dexamethasone: Dexamethasone in nerve block\n\nIntravenous saline'}], 'classes': [{'categories': [{'measurements': [{'value': '-7', 'groupId': 'OG000', 'lowerLimit': '-16', 'upperLimit': '2'}, {'value': '3.4', 'groupId': 'OG001', 'lowerLimit': '-6.3', 'upperLimit': '13.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Postoperative day 7-10', 'description': 'Patients will be asked whether they believe they were in the IV dexamethasone or intravenous dexamethasone group', 'unitOfMeasure': '% of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intravenous Dexamethasone', 'description': 'Patients will receive 1 cc (1 mg) dexamethasone intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc saline.\n\nBupivacaine\n\nIntravenous dexamethasone\n\nPerineural saline: Saline in nerve block'}, {'id': 'FG001', 'title': 'Perineural Dexamethasone', 'description': 'Patients will receive 1 cc saline intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc (1 mg) dexamethasone.\n\nBupivacaine\n\nPerineural dexamethasone: Dexamethasone in nerve block\n\nIntravenous saline'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '64'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '63'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intravenous Dexamethasone', 'description': 'Patients will receive 1 cc (1 mg) dexamethasone intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc saline.\n\nBupivacaine\n\nIntravenous dexamethasone\n\nPerineural saline: Saline in nerve block'}, {'id': 'BG001', 'title': 'Perineural Dexamethasone', 'description': 'Patients will receive 1 cc saline intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc (1 mg) dexamethasone.\n\nBupivacaine\n\nPerineural dexamethasone: Dexamethasone in nerve block\n\nIntravenous saline'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.7', 'spread': '14.6', 'groupId': 'BG000'}, {'value': '49.9', 'spread': '13.6', 'groupId': 'BG001'}, {'value': '48.3', 'spread': '14.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-31', 'studyFirstSubmitDate': '2015-07-02', 'resultsFirstSubmitDate': '2018-01-29', 'studyFirstSubmitQcDate': '2015-07-21', 'lastUpdatePostDateStruct': {'date': '2018-08-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-07-31', 'studyFirstPostDateStruct': {'date': '2015-07-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nerve Block Duration', 'timeFrame': 'Postoperative day 2+', 'description': 'Time at which the pain relief from the block has completely worn off'}], 'secondaryOutcomes': [{'measure': 'Numerical Rating Scale Pain Scores', 'timeFrame': 'Duration of stay in recovery room after surgery (average of 3 hours)', 'description': 'The 11-point numeric scale ranges from \'0\' representing one pain extreme (e.g. "no pain") to \'10\' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")'}, {'measure': 'Opioid Consumption', 'timeFrame': 'Postoperative day 2, postoperative day 3'}, {'measure': 'Side Effects', 'timeFrame': 'Postoperative day 2, postoperative day 3', 'description': 'Opioid-related symptom distress scale is calculated using responses to the symptom severity questions only.\n\nFor each symptom, severity is assessed by the question: "(If yes), how severe was it usually?" (In the past 24 hours) The responses to the severity questions are measured on a 5-point scale from 0-4 in ascending order as follows: Did not have symptom (0) Slight (1) Moderate (2) Severe (3) Very severe (4)'}, {'measure': 'Block Satisfaction', 'timeFrame': 'Postoperative day 2, postoperative day 3', 'description': '0-10 scale (0=not satisfied; 10=extremely satisfied)'}, {'measure': 'Block-related Complications', 'timeFrame': 'Postoperative day 7-10'}, {'measure': '% of Participants Who Guessed the Correct Group', 'timeFrame': 'Postoperative day 7-10', 'description': 'Patients will be asked whether they believe they were in the IV dexamethasone or intravenous dexamethasone group'}]}, 'conditionsModule': {'conditions': ['Pain', 'Shoulder Arthroscopy']}, 'referencesModule': {'references': [{'pmid': '29889698', 'type': 'DERIVED', 'citation': 'Kahn RL, Cheng J, Gadulov Y, Fields KG, YaDeau JT, Gulotta LV. Perineural Low-Dose Dexamethasone Prolongs Interscalene Block Analgesia With Bupivacaine Compared With Systemic Dexamethasone: A Randomized Trial. Reg Anesth Pain Med. 2018 Aug;43(6):572-579. doi: 10.1097/AAP.0000000000000817.'}]}, 'descriptionModule': {'briefSummary': 'Many patients undergoing ambulatory shoulder arthroscopy experience moderate to severe pain after surgery. Finding ways to minimize postoperative pain are ideal. Dexamethasone is a corticosteroid that is commonly used to prevent and/or treat nausea and inflammation. The addition of higher doses of dexamethasone to nerve blocks, which are injections of local anesthetics into the upper shoulder area, has been shown to prolong block duration and reduce pain. However, it is unclear whether the advantage of longer pain relief outweighs patient dissatisfaction with the prolonged feeling of a numb arm. Furthermore, recent studies have shown that systemic, intravenously administered dexamethasone may similarly reduce pain levels when compared with dexamethasone in the block. In our study, the investigators propose to examine the effect of low-dose IV versus block dexamethasone on interscalene block duration in patients undergoing shoulder arthroscopy. Most studies have used 4 mg or more. One study suggests that 1 mg may have the same effect as larger doses. Our aims are to determine whether the addition of low-dose dexamethasone to a local anesthetic in the block can prolong its duration, and whether there are differences in postoperative pain, consumption of painkillers, side effects, and satisfaction in patients who received IV or block dexamethasone. Patients (128 total) will be randomly assigned to either receive IV or block dexamethasone, and postoperative assessments (pain, painkiller use, side effects, block duration, satisfaction, complications) will be made via phone at 2, 3, 4 (if needed), and 7-10 days after surgery. Results from this study will reveal whether patients prefer the longer-duration analgesia that may be obtained with low-dose dexamethasone in the block.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients having ambulatory arthroscopic shoulder surgery under ultrasound-guided interscalene block (rotator cuffs, acromioplasties, stabilizations, labral repairs, etc.)\n* Age 18-70 years\n\nExclusion Criteria:\n\n* Contraindication to interscalene block\n* Known allergy/sensitivity to any study medications\n* Having taken daily steroids for 10 days or longer anytime during the past year\n* Body mass index \\<18 or \\>40\n* History of uncontrolled nausea and vomiting with opioids or severe post-op nausea and vomiting (to prevent any need for higher doses of IV dexamethasone)\n* Non-English speaking\n* Revision procedures\n* Additional procedures (e.g., removal of hardware, procedures involving other areas, etc.)\n* Planned open procedures\n* History of diabetes\n* Arthroscopic irrigation and debridement secondary to infection\n* Peripheral neuropathies affecting the operative extremity\n* Having taken opiates daily for 10 days or longer immediately preceding surgery, 3 times a week for greater than 3 months anytime in the past year, or currently taking for anything other than shoulder pain'}, 'identificationModule': {'nctId': 'NCT02506660', 'acronym': 'Dex ISB', 'briefTitle': 'Interscalene Block With Low-dose IV vs. Perineural Dexamethasone for Shoulder Arthroscopy', 'organization': {'class': 'OTHER', 'fullName': 'Hospital for Special Surgery, New York'}, 'officialTitle': 'Interscalene Block With Low-dose IV vs. Perineural Dexamethasone for Shoulder Arthroscopy', 'orgStudyIdInfo': {'id': '2014-379'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intravenous dexamethasone', 'description': 'Patients will receive 1 cc (1 mg) dexamethasone intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc saline.', 'interventionNames': ['Drug: Bupivacaine', 'Drug: Intravenous dexamethasone', 'Drug: Perineural saline']}, {'type': 'EXPERIMENTAL', 'label': 'Perineural dexamethasone', 'description': 'Patients will receive 1 cc saline intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc (1 mg) dexamethasone.', 'interventionNames': ['Drug: Bupivacaine', 'Drug: Perineural dexamethasone', 'Drug: Intravenous saline']}], 'interventions': [{'name': 'Bupivacaine', 'type': 'DRUG', 'armGroupLabels': ['Intravenous dexamethasone', 'Perineural dexamethasone']}, {'name': 'Perineural dexamethasone', 'type': 'DRUG', 'description': 'Dexamethasone in nerve block', 'armGroupLabels': ['Perineural dexamethasone']}, {'name': 'Intravenous dexamethasone', 'type': 'DRUG', 'armGroupLabels': ['Intravenous dexamethasone']}, {'name': 'Intravenous saline', 'type': 'DRUG', 'armGroupLabels': ['Perineural dexamethasone']}, {'name': 'Perineural saline', 'type': 'DRUG', 'description': 'Saline in nerve block', 'armGroupLabels': ['Intravenous dexamethasone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Hospital for Special Surgery', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Richard Kahn', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital for Special Surgery, New York'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital for Special Surgery, New York', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}