Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2026-02-23 @ 6:27 AM
Study NCT ID:
NCT01986751
Status:
TERMINATED
Last Update Posted:
2016-11-04
First Post:
2013-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effectiveness of Perineural Clonidine as an Adjuvant With Ropivacaine for Popliteal Nerve Block in Patients Undergoing Foot and Ankle Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D001733', 'term': 'Bites and Stings'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011041', 'term': 'Poisoning'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003000', 'term': 'Clonidine'}, {'id': 'D000077212', 'term': 'Ropivacaine'}], 'ancestors': [{'id': 'D048288', 'term': 'Imidazolines'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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': 'pkukreja@uabmc.edu', 'phone': '205-996-7025', 'title': 'Dr. Promil Kukreja', 'organization': 'University of Alabama Birmingham'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Clonidine and Ropivacaine (Study Group)', 'description': 'A bolus of 20 mL of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Ropivacaine (Control)', 'description': 'Standard saphenous nerve block (adductor canal approach) will be performed using 20 ml of 0.5% ropivacaine', 'otherNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Time to Onset of Sensory and Motor Block Between the Study Group and the Control Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clonidine and Ropivacaine (Study Group)', 'description': 'A bolus of 20ml of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.'}, {'id': 'OG001', 'title': 'Ropivacaine (Control)', 'description': 'A bolus of 20ml of 0.5% ropivacaine will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.'}], 'timeFrame': 'baseline to 72 hours', 'description': 'Mean time onset of sensory block and motor block between the study group and the control group to assess the efficacy of clonidine to prolong the block duration.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was prematurely terminated. No data were collected for this assessment.'}, {'type': 'PRIMARY', 'title': 'Compare the Mean Duration of Sensory and/or Motor Block Between the Study Group and the Control Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clonidine and Ropivacaine (Study Group)', 'description': 'A bolus of 20ml of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.'}, {'id': 'OG001', 'title': 'Ropivacaine (Control)', 'description': 'A bolus of 20ml of 0.5% ropivacaine will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.'}], 'timeFrame': 'baseline to 72 hours', 'description': 'Mean duration of sensory and/or motor block between the study group and the control group to assess the efficacy of clonidine to prolong the block duration.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was prematurely terminated. No data were collected for this assessment'}, {'type': 'SECONDARY', 'title': 'Compare the Mean VAS Scores at 24 Hours Post Procecure to Determine the Effectiveness of Perineural Clonidine on Duration of Postoperative Analgesia Between the Control Group and Study Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clonidine and Ropivacaine (Study Group)', 'description': 'A bolus of 20ml of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.'}, {'id': 'OG001', 'title': 'Ropivacaine (Control)', 'description': 'A bolus of 20ml of 0.5% ropivacaine will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.'}], 'timeFrame': 'baseline to 24 hours post block', 'description': 'The VAS score is measured as 0 - 10 with 0 being no pain to 10 being the worst pain imaginable to assess the efficacy of clonidine to control postoperative pain and patient satisfaction at the time of discharge.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was prematurely terminated. No data were collected for this assessment'}, {'type': 'SECONDARY', 'title': 'Compare the Opioid Consumption During the First 24 Hours Between the Study Group and the Control Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clonidine and Ropivacaine (Study Group)', 'description': 'A bolus of 20ml of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.'}, {'id': 'OG001', 'title': 'Ropivacaine (Control)', 'description': 'A bolus of 20ml of 0.5% ropivacaine will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.'}], 'timeFrame': 'baseline to 24 hours post block', 'description': 'Mg equivalent of morphine consumption during the first 24 hours between the study group and the control group', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was prematurely terminated. No data were collected for this assessment'}, {'type': 'SECONDARY', 'title': 'Compare the Subjects Mean Arterial Blood Pressure Effect of Perineural Clonidine Versus Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clonidine and Ropivacaine (Study Group)', 'description': 'A bolus of 20ml of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose). Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.'}, {'id': 'OG001', 'title': 'Ropivacaine (Control)', 'description': 'A bolus of 20ml of 0.5% ropivacaine will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose). Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.'}], 'timeFrame': 'baseline to discharge from hospital (expected 3 days)', 'description': 'Comparing the mean arterial blood pressure between the study group and the control group to assess the effect of clonidine on blood pressure.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was prematurely terminated. No data were collected for this assessment'}, {'type': 'SECONDARY', 'title': 'the Mean Time to Discharge After Start of Procedure for Each Group - Control and Study Group.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clonidine and Ropivacaine (Study Group)', 'description': 'A bolus of 20ml of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose). Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.'}, {'id': 'OG001', 'title': 'Ropivacaine (Control)', 'description': 'A bolus of 20ml of 0.5% ropivacaine will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose). Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.'}], 'timeFrame': 'baseline to discharge (approximately 72 hours)', 'description': 'Comparing the mean hours from start of procedure to discharge between the study group and the control group', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was prematurely terminated. No data were collected for this assessment'}, {'type': 'SECONDARY', 'title': 'Mean Time to First Analgesic Intake Postoperative Between the Control Group and the Study Group.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clonidine and Ropivacaine (Study Group)', 'description': 'A bolus of 20ml of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose). Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.'}, {'id': 'OG001', 'title': 'Ropivacaine (Control)', 'description': 'A bolus of 20ml of 0.5% ropivacaine will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose). Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.'}], 'timeFrame': 'baseline to 24 hours post block', 'description': 'Comparing the mean time to the first analgesic intake postoperative between the control group and the study group', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was prematurely terminated. No data were collected for this assessment'}, {'type': 'SECONDARY', 'title': 'Compare the Mean VAS Scores at 24 Hours Post Procedure to Determine the Patient Satisfaction on Duration of Postoperative Analgesia Between Control Group and Study Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clonidine and Ropivacaine', 'description': 'A bolus of 20ml of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose). Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.'}, {'id': 'OG001', 'title': 'Ropivacaine', 'description': 'A bolus of 20ml of 0.5% ropivacaine will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose). Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.'}], 'timeFrame': 'baseline to 24 hours', 'description': 'Compare the mean VAS scores at 24 hours between the study group and the control group to assess the efficacy of clonidine to control postoperative pain and patient satisfaction at the time of discharge.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was prematurely terminated. No data were collected for this assessment'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Clonidine and Ropivacaine', 'description': 'A bolus of 20 mL of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).\n\nClonidine\n\nropivacaine'}, {'id': 'FG001', 'title': 'Ropivacaine', 'description': 'Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine\n\nropivacaine'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'improperly consented', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Clonidine and Ropivacaine', 'description': 'A bolus of 20 mL of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).\n\nClonidine\n\nropivacaine'}, {'id': 'BG001', 'title': 'Ropivacaine', 'description': 'Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine\n\nropivacaine'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'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': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'whyStopped': 'failure to enroll', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-15', 'studyFirstSubmitDate': '2013-10-31', 'resultsFirstSubmitDate': '2016-07-20', 'studyFirstSubmitQcDate': '2013-11-11', 'lastUpdatePostDateStruct': {'date': '2016-11-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-09-15', 'studyFirstPostDateStruct': {'date': '2013-11-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-11-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Time to Onset of Sensory and Motor Block Between the Study Group and the Control Group', 'timeFrame': 'baseline to 72 hours', 'description': 'Mean time onset of sensory block and motor block between the study group and the control group to assess the efficacy of clonidine to prolong the block duration.'}, {'measure': 'Compare the Mean Duration of Sensory and/or Motor Block Between the Study Group and the Control Group', 'timeFrame': 'baseline to 72 hours', 'description': 'Mean duration of sensory and/or motor block between the study group and the control group to assess the efficacy of clonidine to prolong the block duration.'}], 'secondaryOutcomes': [{'measure': 'Compare the Mean VAS Scores at 24 Hours Post Procecure to Determine the Effectiveness of Perineural Clonidine on Duration of Postoperative Analgesia Between the Control Group and Study Group', 'timeFrame': 'baseline to 24 hours post block', 'description': 'The VAS score is measured as 0 - 10 with 0 being no pain to 10 being the worst pain imaginable to assess the efficacy of clonidine to control postoperative pain and patient satisfaction at the time of discharge.'}, {'measure': 'Compare the Opioid Consumption During the First 24 Hours Between the Study Group and the Control Group', 'timeFrame': 'baseline to 24 hours post block', 'description': 'Mg equivalent of morphine consumption during the first 24 hours between the study group and the control group'}, {'measure': 'Compare the Subjects Mean Arterial Blood Pressure Effect of Perineural Clonidine Versus Placebo', 'timeFrame': 'baseline to discharge from hospital (expected 3 days)', 'description': 'Comparing the mean arterial blood pressure between the study group and the control group to assess the effect of clonidine on blood pressure.'}, {'measure': 'the Mean Time to Discharge After Start of Procedure for Each Group - Control and Study Group.', 'timeFrame': 'baseline to discharge (approximately 72 hours)', 'description': 'Comparing the mean hours from start of procedure to discharge between the study group and the control group'}, {'measure': 'Mean Time to First Analgesic Intake Postoperative Between the Control Group and the Study Group.', 'timeFrame': 'baseline to 24 hours post block', 'description': 'Comparing the mean time to the first analgesic intake postoperative between the control group and the study group'}, {'measure': 'Compare the Mean VAS Scores at 24 Hours Post Procedure to Determine the Patient Satisfaction on Duration of Postoperative Analgesia Between Control Group and Study Group', 'timeFrame': 'baseline to 24 hours', 'description': 'Compare the mean VAS scores at 24 hours between the study group and the control group to assess the efficacy of clonidine to control postoperative pain and patient satisfaction at the time of discharge.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['nerve', 'block', 'motor blockade', 'lower extremity pain', 'nerve block'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'Nerve blocks are used to decrease the amount of pain you have after surgery. We are asking you to take part in a research study. This research study will test whether adding a medicine called clonidine to nerve blocks helps to improve them. Nerve blocks typically last less than a day after surgery. We are looking for ways to make them work better and last longer. Clonidine is approved for use as a blood pressure medicine. Its use in nerve blocks is investigational, but it may help nerve blocks to last longer. Adding clonidine to nerve blocks may also decrease the amount of pain medicine a person has after surgery. All people who enter this study will receive a nerve block with the normal medicine, but half of people will also have clonidine added to their nerve block. This study will enroll 60 participants from UAB hospitals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient undergoing foot or ankle surgery with popliteal nerve block planned for postoperative analgesia.\n2. Adult, 19 years of age and older.\n3. Subject classified as American Society of Anesthesiology (ASA) class 1, 2, or 3. The ASA defines these statuses as follows: 1-A normal healthy patient. 2-A patient with mild systemic disease. 3-A patient with severe systemic disease.\n\n \\-\n\nExclusion Criteria:\n\n1. Any subject not classified as an ASA 1, 2, or 3.\n2. Allergy/intolerance to local anesthetic, clonidine, and/or oxycodone.\n3. Subject with a history of continuous opioid use for greater than one month prior to surgery.\n4. Pre-existing neurologic deficit in lower extremity (surgical site).\n5. Clinically significant coagulopathy (hemophilia, von Willebrand disease).\n6. Patients who fail to follow the UAB Department of Anesthesiology Algorithm for the Preoperative Management of an Angiotensin Converting Enzyme Inhibitor (ACEI) or an Angiotensin Receptor Blocker (ARB). A copy of the algorithm can be found in Appendix 1. -'}, 'identificationModule': {'nctId': 'NCT01986751', 'briefTitle': 'Effectiveness of Perineural Clonidine as an Adjuvant With Ropivacaine for Popliteal Nerve Block in Patients Undergoing Foot and Ankle Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Effectiveness of Perineural Clonidine as an Adjuvant With Ropivacaine for Popliteal Nerve Block in Patients Undergoing Foot and Ankle Surgery', 'orgStudyIdInfo': {'id': 'F130625002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Clonidine and Ropivacaine', 'description': 'A bolus of 20 mL of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).', 'interventionNames': ['Drug: Clonidine', 'Drug: ropivacaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ropivacaine', 'description': 'Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine', 'interventionNames': ['Drug: ropivacaine']}], 'interventions': [{'name': 'Clonidine', 'type': 'DRUG', 'otherNames': ['Catapres, Kapvay, Nexiclon, Jenloga, Duraclon'], 'armGroupLabels': ['Clonidine and Ropivacaine']}, {'name': 'ropivacaine', 'type': 'DRUG', 'armGroupLabels': ['Clonidine and Ropivacaine', 'Ropivacaine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'overallOfficials': [{'name': 'Promil Kukreja, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Promil Kukreja', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}