Ignite Creation Date:
2025-12-26 @ 4:00 PM
Ignite Modification Date:
2026-01-01 @ 4:11 AM
Study NCT ID:
NCT01586806
Status:
COMPLETED
Last Update Posted:
2016-11-28
First Post:
2012-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparing Subsartorial Saphenous Nerve Blocks With and Without Dexamethasone for Anterior Cruciate Ligament Reconstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D014839', 'term': 'Vomiting'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'chisholmm@hss.edu', 'phone': '2126061206', 'title': 'Dr. Mary Chisholm', 'organization': 'Hospital for Special Surgery'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Control', 'description': 'Bupivacaine Only: This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).', 'otherNumAtRisk': 65, 'otherNumAffected': 0, 'seriousNumAtRisk': 65, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Dexamethasone 1 mg', 'description': 'Bupivacaine with 1 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.', 'otherNumAtRisk': 65, 'otherNumAffected': 0, 'seriousNumAtRisk': 65, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Dexamethasone 4 mg', 'description': 'Bupivacaine with 4 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.', 'otherNumAtRisk': 65, 'otherNumAffected': 0, 'seriousNumAtRisk': 65, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Patient-perceived Duration of Analgesia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Bupivacaine Only: This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).'}, {'id': 'OG001', 'title': 'Dexamethasone 1 mg', 'description': 'Bupivacaine with 1 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.'}, {'id': 'OG002', 'title': 'Dexamethasone 4 mg', 'description': 'Bupivacaine with 4 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.'}], 'classes': [{'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000', 'lowerLimit': '28.4', 'upperLimit': '37.3'}, {'value': '41', 'groupId': 'OG001', 'lowerLimit': '32.4', 'upperLimit': '50.9'}, {'value': '46.5', 'groupId': 'OG002', 'lowerLimit': '35.8', 'upperLimit': '48.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 2 days following surgery', 'description': 'After discharge, patients will be called and given instructions to help determine length of time of analgesia in the saphenous nerve distribution.', 'unitOfMeasure': 'hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'NRS (Numerical Rating Scale) Pain Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Bupivacaine Only: This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).'}, {'id': 'OG001', 'title': 'Dexamethasone 1 mg', 'description': 'Bupivacaine with 1 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.'}, {'id': 'OG002', 'title': 'Dexamethasone 4 mg', 'description': 'Bupivacaine with 4 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '5'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '4'}, {'value': '2', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Postoperative day 1', 'description': 'Patients will be asked to rate, on a scale of 0-10, their pain while at rest. 0 indicates no pain, and 10 indicates the worst pain imaginable.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Bupivacaine Only: This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).'}, {'id': 'OG001', 'title': 'Dexamethasone 1 mg', 'description': 'Bupivacaine with 1 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.'}, {'id': 'OG002', 'title': 'Dexamethasone 4 mg', 'description': 'Bupivacaine with 4 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '9'}, {'value': '8', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': '9'}, {'value': '9', 'groupId': 'OG002', 'lowerLimit': '8', 'upperLimit': '10'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 2 days following surgery', 'description': 'Patients will be asked to rate satisfaction on a scale of 0-10 (0=completely dissatisfied, 10=completely satisfied);', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Postoperative Morphine Consumption', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Bupivacaine Only: This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).'}, {'id': 'OG001', 'title': 'Dexamethasone 1 mg', 'description': 'Bupivacaine with 1 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.'}, {'id': 'OG002', 'title': 'Dexamethasone 4 mg', 'description': 'Bupivacaine with 4 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.'}], 'classes': [{'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000', 'lowerLimit': '26.3', 'upperLimit': '60'}, {'value': '30', 'groupId': 'OG001', 'lowerLimit': '22.5', 'upperLimit': '60'}, {'value': '30', 'groupId': 'OG002', 'lowerLimit': '15', 'upperLimit': '52.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 2 days following surgery', 'description': 'Data collector will record how many opioids (i.e. Percocet, Vicodin) the patient has used since discharge.', 'unitOfMeasure': 'milligrams', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Opioid-Related Side Effects (Drowsiness)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Bupivacaine Only: This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).'}, {'id': 'OG001', 'title': 'Dexamethasone 1 mg', 'description': 'Bupivacaine with 1 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.'}, {'id': 'OG002', 'title': 'Dexamethasone 4 mg', 'description': 'Bupivacaine with 4 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1.6'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1.7'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '1.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 2 days following surgery', 'description': 'Data collector will administer the Opioid-Related Distress Scale (OR-SDS) to determine if patients experience any opioid-related side effects (i.e. drowsiness). The OR-SDS score is on a scale of 0 to 4, with a higher number representing more severe symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control', 'description': 'Bupivacaine Only: This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).'}, {'id': 'FG001', 'title': 'Dexamethasone 1 mg', 'description': 'Bupivacaine with 1 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.'}, {'id': 'FG002', 'title': 'Dexamethasone 4 mg', 'description': 'Bupivacaine with 4 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '65'}, {'groupId': 'FG002', 'numSubjects': '65'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '61'}, {'groupId': 'FG002', 'numSubjects': '63'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}, {'value': '186', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Control', 'description': 'Bupivacaine Only: This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).'}, {'id': 'BG001', 'title': 'Dexamethasone 1 mg', 'description': 'Bupivacaine with 1 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.'}, {'id': 'BG002', 'title': 'Dexamethasone 4 mg', 'description': 'Bupivacaine with 4 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '27', 'spread': '10', 'groupId': 'BG000'}, {'value': '26', 'spread': '8', 'groupId': 'BG001'}, {'value': '27', 'spread': '10', 'groupId': 'BG002'}, {'value': '26', 'spread': '9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '121', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}, {'value': '186', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '24', 'spread': '3', 'groupId': 'BG000'}, {'value': '24', 'spread': '4', 'groupId': 'BG001'}, {'value': '25', 'spread': '3', 'groupId': 'BG002'}, {'value': '25', 'spread': '4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/(m^2)', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 195}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-07', 'studyFirstSubmitDate': '2012-04-25', 'resultsFirstSubmitDate': '2016-05-03', 'studyFirstSubmitQcDate': '2012-04-26', 'lastUpdatePostDateStruct': {'date': '2016-11-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-05-03', 'studyFirstPostDateStruct': {'date': '2012-04-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-06-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient-perceived Duration of Analgesia', 'timeFrame': 'Up to 2 days following surgery', 'description': 'After discharge, patients will be called and given instructions to help determine length of time of analgesia in the saphenous nerve distribution.'}], 'secondaryOutcomes': [{'measure': 'NRS (Numerical Rating Scale) Pain Scores', 'timeFrame': 'Postoperative day 1', 'description': 'Patients will be asked to rate, on a scale of 0-10, their pain while at rest. 0 indicates no pain, and 10 indicates the worst pain imaginable.'}, {'measure': 'Patient Satisfaction', 'timeFrame': 'Up to 2 days following surgery', 'description': 'Patients will be asked to rate satisfaction on a scale of 0-10 (0=completely dissatisfied, 10=completely satisfied);'}, {'measure': 'Postoperative Morphine Consumption', 'timeFrame': 'Up to 2 days following surgery', 'description': 'Data collector will record how many opioids (i.e. Percocet, Vicodin) the patient has used since discharge.'}, {'measure': 'Opioid-Related Side Effects (Drowsiness)', 'timeFrame': 'Up to 2 days following surgery', 'description': 'Data collector will administer the Opioid-Related Distress Scale (OR-SDS) to determine if patients experience any opioid-related side effects (i.e. drowsiness). The OR-SDS score is on a scale of 0 to 4, with a higher number representing more severe symptoms.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Dexamethasone', 'Glucocorticoids', 'Physiological Effects of Drugs', 'Therapeutic Uses', 'Anterior Cruciate Ligament Reconstruction', 'Regional Anesthesia, nerve block', 'Ultrasonic Imaging', 'Post-Operative Complications: muscle weakness, pain, nausea and vomiting', 'Dexamethasone (as local anesthetic additive)'], 'conditions': ['Anterior Cruciate Ligament Reconstruction', 'Regional Anesthesia, Saphenous Nerve Block']}, 'referencesModule': {'references': [{'pmid': '20009936', 'type': 'BACKGROUND', 'citation': 'Vieira PA, Pulai I, Tsao GC, Manikantan P, Keller B, Connelly NR. Dexamethasone with bupivacaine increases duration of analgesia in ultrasound-guided interscalene brachial plexus blockade. Eur J Anaesthesiol. 2010 Mar;27(3):285-8. doi: 10.1097/EJA.0b013e3283350c38.'}, {'pmid': '21676892', 'type': 'BACKGROUND', 'citation': 'Cummings KC 3rd, Napierkowski DE, Parra-Sanchez I, Kurz A, Dalton JE, Brems JJ, Sessler DI. Effect of dexamethasone on the duration of interscalene nerve blocks with ropivacaine or bupivacaine. Br J Anaesth. 2011 Sep;107(3):446-53. doi: 10.1093/bja/aer159. Epub 2011 Jun 14.'}, {'pmid': '7999421', 'type': 'BACKGROUND', 'citation': 'Portenoy RK, Thaler HT, Kornblith AB, Lepore JM, Friedlander-Klar H, Kiyasu E, Sobel K, Coyle N, Kemeny N, Norton L, et al. The Memorial Symptom Assessment Scale: an instrument for the evaluation of symptom prevalence, characteristics and distress. Eur J Cancer. 1994;30A(9):1326-36. doi: 10.1016/0959-8049(94)90182-1.'}, {'pmid': '15333398', 'type': 'BACKGROUND', 'citation': 'Apfelbaum JL, Gan TJ, Zhao S, Hanna DB, Chen C. Reliability and validity of the perioperative opioid-related symptom distress scale. Anesth Analg. 2004 Sep;99(3):699-709. doi: 10.1213/01.ANE.0000133143.60584.38.'}, {'pmid': '17005509', 'type': 'BACKGROUND', 'citation': 'Lundblad M, Kapral S, Marhofer P, Lonnqvist PA. Ultrasound-guided infrapatellar nerve block in human volunteers: description of a novel technique. Br J Anaesth. 2006 Nov;97(5):710-4. doi: 10.1093/bja/ael241. Epub 2006 Sep 26.'}, {'pmid': '18574578', 'type': 'BACKGROUND', 'citation': 'Akkaya T, Ersan O, Ozkan D, Sahiner Y, Akin M, Gumus H, Ates Y. Saphenous nerve block is an effective regional technique for post-menisectomy pain. Knee Surg Sports Traumatol Arthrosc. 2008 Sep;16(9):855-8. doi: 10.1007/s00167-008-0572-4. Epub 2008 Jun 24.'}], 'seeAlsoLinks': [{'url': 'http://www.hss.edu/', 'label': 'This is the link to Hospital for Special Surgery website.'}]}, 'descriptionModule': {'briefSummary': 'For patients undergoing Anterior Cruciate Ligament reconstruction surgery, the postoperative period can be a painful experience without adequate pain management. Hence the investigators propose a randomized controlled clinical study, investigating prolonged saphenous nerve blocks. Patients will be randomized to receive saphenous nerve blocks with or without dexamethasone, a corticosteroid used to prolong analgesia.\n\nDepending on the randomized treatment assignment, patients may receive one of the following:\n\n1. 13 ml of 0.5% bupivacaine, a local anesthetic (no dexamethasone);\n2. 13 ml of 0.5% bupivacaine mixed with 1 mg of dexamethasone;\n3. 13 ml of 0.5% bupivacaine mixed with 4 mg of dexamethasone.\n\nPatients will be followed postoperatively. Following admission to the recovery room, data collectors will ask patients to rate their pain on a scale of 0-10 until discharge. Data collectors will also record patient satisfaction, pain medication use and any side effects experienced (i.e. nausea and vomiting). Patients will then be contacted on postoperative days 1, 2 and 14 and asked questions about their general well-being.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing ambulatory surgery for anterior cruciate ligament (ACL) reconstruction with a patella tendon autograft.\n* ASA I-III \\[American Society of Anesthesiologists (ASA) Physical Status classification system\\]\n* BMI \\< 35\n* Smokers included\n* Ages 16-65\n\nExclusion Criteria:\n\n* Patients on steroids or requiring stress dose steroids\n* BMI \\> 35\n* Patient refusal\n* Allergy to study medications,\n* NRS scores \\> 3 with frequent opioid use (including tramadol) prior to surgery-daily for greater than 3 weeks\n* Lower extremity neurological dysfunction\n* Diabetic (NIDDM, insulin-dependent and/or oral hypoglycemic dependent)\n* Not in included age range (under 16 or over 65 years of age)\n* Contraindications to the use of dexamethasone\n* Non-English speaking patients. We will be using the Short Form 8 Health Survey, as well as the OR-SDS questionnaire (these are in English; any translations would have to be separately validated).'}, 'identificationModule': {'nctId': 'NCT01586806', 'briefTitle': 'Comparing Subsartorial Saphenous Nerve Blocks With and Without Dexamethasone for Anterior Cruciate Ligament Reconstruction', 'organization': {'class': 'OTHER', 'fullName': 'Hospital for Special Surgery, New York'}, 'officialTitle': 'Postoperative Analgesia Comparing Subsartorial Saphenous Nerve Block With and Without Dexamethasone in ACL Reconstruction', 'orgStudyIdInfo': {'id': 'IRB #2012-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'interventionNames': ['Drug: Bupivacaine Only']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dexamethasone 1 mg', 'interventionNames': ['Drug: Bupivacaine with 1 mg of Dexamethasone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dexamethasone 4 mg', 'interventionNames': ['Drug: Bupivacaine with 4 mg of Dexamethasone']}], 'interventions': [{'name': 'Bupivacaine Only', 'type': 'DRUG', 'description': 'This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).', 'armGroupLabels': ['Control']}, {'name': 'Bupivacaine with 1 mg of Dexamethasone', 'type': 'DRUG', 'description': 'This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.', 'armGroupLabels': ['Dexamethasone 1 mg']}, {'name': 'Bupivacaine with 4 mg of Dexamethasone', 'type': 'DRUG', 'description': 'This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.', 'armGroupLabels': ['Dexamethasone 4 mg']}]}, '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': 'Mary F. Chisholm, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital for Special Surgery, New York'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital for Special Surgery, New York', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}