Ignite Creation Date:
2025-12-24 @ 10:20 PM
Ignite Modification Date:
2026-01-06 @ 9:27 AM
Study NCT ID:
NCT02198235
Status:
COMPLETED
Last Update Posted:
2017-06-15
First Post:
2012-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Prolonged Popliteal Fossa Nerve Blockade (Prolonged Pop)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D002047', 'term': 'Buprenorphine'}], 'ancestors': [{'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'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'yadeauj@hss.edu', 'phone': '212-606-1206', 'title': 'Dr. Jacques YaDeau', 'organization': 'Hospital for Special Surgery'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Control Nerve Block + IV Dexamethasone', 'description': 'IV Dexamethasone (4 mg)\n\nDexamethasone', 'otherNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Nerve Block + IV Dexamethasone + IV Buprenorphine', 'description': 'IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg)\n\nDexamethasone\n\nBuprenorphine', 'otherNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Nerve Block With Dexamethasone + Buprenorphine in Block.', 'description': 'Dexamethasone (4 mg) Buprenorphine (150 mcg)\n\nDexamethasone\n\nBuprenorphine', 'otherNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Numeric Rating Scale (NRS) Pain Score With Movement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Nerve Block + IV Dexamethasone', 'description': 'IV Dexamethasone (4 mg)\n\nDexamethasone'}, {'id': 'OG001', 'title': 'Control Nerve Block + IV Dexamethasone + IV Buprenorphine', 'description': 'IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg)\n\nDexamethasone\n\nBuprenorphine'}, {'id': 'OG002', 'title': 'Nerve Block With Dexamethasone + Buprenorphine in Block.', 'description': 'Dexamethasone (4 mg) Buprenorphine (150 mcg)\n\nDexamethasone\n\nBuprenorphine'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '1', 'spread': '1.6', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '2.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours after the popliteal block is given', 'description': 'Pain with movement at 24 hours from the nerve block (0-10; 0 = no pain, 10 = worst possible pain)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Block Duration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Nerve Block + IV Dexamethasone', 'description': 'IV Dexamethasone (4 mg)\n\nDexamethasone'}, {'id': 'OG001', 'title': 'Control Nerve Block + IV Dexamethasone + IV Buprenorphine', 'description': 'IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg)\n\nDexamethasone\n\nBuprenorphine'}, {'id': 'OG002', 'title': 'Nerve Block With Dexamethasone + Buprenorphine in Block.', 'description': 'Dexamethasone (4 mg) Buprenorphine (150 mcg)\n\nDexamethasone\n\nBuprenorphine'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000', 'lowerLimit': '24.1', 'upperLimit': '45.2'}, {'value': '37.9', 'groupId': 'OG001', 'lowerLimit': '30.7', 'upperLimit': '43.9'}, {'value': '45.6', 'groupId': 'OG002', 'lowerLimit': '33.9', 'upperLimit': '53.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '24 hours and 48 hours after the popliteal block is given', 'description': 'When did the nerve block entirely wear off?', 'unitOfMeasure': 'hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Numeric Rating Scale (NRS) Pain Score at Rest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Nerve Block + IV Dexamethasone', 'description': 'IV Dexamethasone (4 mg)\n\nDexamethasone'}, {'id': 'OG001', 'title': 'Control Nerve Block + IV Dexamethasone + IV Buprenorphine', 'description': 'IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg)\n\nDexamethasone\n\nBuprenorphine'}, {'id': 'OG002', 'title': 'Nerve Block With Dexamethasone + Buprenorphine in Block.', 'description': 'Dexamethasone (4 mg) Buprenorphine (150 mcg)\n\nDexamethasone\n\nBuprenorphine'}], 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '.9', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '.8', 'spread': '1.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours after the popliteal block is given', 'description': 'Pain at rest at 24 hours from the nerve block (0-10; 0 = no pain, 10 = worst possible pain)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Median Time to Requiring Oral Opioids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Nerve Block + IV Dexamethasone', 'description': 'IV Dexamethasone (4 mg)\n\nDexamethasone'}, {'id': 'OG001', 'title': 'Control Nerve Block + IV Dexamethasone + IV Buprenorphine', 'description': 'IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg)\n\nDexamethasone\n\nBuprenorphine'}, {'id': 'OG002', 'title': 'Nerve Block With Dexamethasone + Buprenorphine in Block.', 'description': 'Dexamethasone (4 mg) Buprenorphine (150 mcg)\n\nDexamethasone\n\nBuprenorphine'}], 'classes': [{'categories': [{'measurements': [{'value': '25.5', 'groupId': 'OG000', 'lowerLimit': '18.0', 'upperLimit': '34.7'}, {'value': '30', 'groupId': 'OG001', 'lowerLimit': '26.8', 'upperLimit': '40.5'}, {'value': '35.3', 'groupId': 'OG002', 'lowerLimit': '30.3', 'upperLimit': '55.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '24 hours after the popliteal block is given', 'description': 'Did patient have pain requiring oral opioids?', 'unitOfMeasure': 'hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control Nerve Block + IV Dexamethasone', 'description': 'IV Dexamethasone (4 mg)\n\nDexamethasone'}, {'id': 'FG001', 'title': 'Control Nerve Block + IV Dexamethasone + IV Buprenorphine', 'description': 'IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg)\n\nDexamethasone\n\nBuprenorphine'}, {'id': 'FG002', 'title': 'Nerve Block With Dexamethasone + Buprenorphine in Block.', 'description': 'Dexamethasone (4 mg) Buprenorphine (150 mcg)\n\nDexamethasone\n\nBuprenorphine'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Control Nerve Block + IV Dexamethasone', 'description': 'IV Dexamethasone (4 mg)\n\nDexamethasone'}, {'id': 'BG001', 'title': 'Control Nerve Block + IV Dexamethasone + IV Buprenorphine', 'description': 'IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg)\n\nDexamethasone\n\nBuprenorphine'}, {'id': 'BG002', 'title': 'Nerve Block With Dexamethasone + Buprenorphine in Block.', 'description': 'Dexamethasone (4 mg) Buprenorphine (150 mcg)\n\nDexamethasone\n\nBuprenorphine'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.2', 'spread': '15.9', 'groupId': 'BG000'}, {'value': '51.1', 'spread': '15.3', 'groupId': 'BG001'}, {'value': '52.8', 'spread': '14.2', 'groupId': 'BG002'}, {'value': '51.7', 'spread': '15', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'BMI (Body Mass Index)', 'classes': [{'categories': [{'measurements': [{'value': '27.2', 'spread': '5.68', 'groupId': 'BG000'}, {'value': '26.3', 'spread': '4.37', 'groupId': 'BG001'}, {'value': '26.3', 'spread': '5.16', 'groupId': 'BG002'}, {'value': '26.6', 'spread': '5.05', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-22', 'studyFirstSubmitDate': '2012-09-21', 'resultsFirstSubmitDate': '2015-07-21', 'studyFirstSubmitQcDate': '2014-07-22', 'lastUpdatePostDateStruct': {'date': '2017-06-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-01-29', 'studyFirstPostDateStruct': {'date': '2014-07-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-02-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numeric Rating Scale (NRS) Pain Score With Movement', 'timeFrame': '24 hours after the popliteal block is given', 'description': 'Pain with movement at 24 hours from the nerve block (0-10; 0 = no pain, 10 = worst possible pain)'}], 'secondaryOutcomes': [{'measure': 'Block Duration', 'timeFrame': '24 hours and 48 hours after the popliteal block is given', 'description': 'When did the nerve block entirely wear off?'}, {'measure': 'Numeric Rating Scale (NRS) Pain Score at Rest', 'timeFrame': '24 hours after the popliteal block is given', 'description': 'Pain at rest at 24 hours from the nerve block (0-10; 0 = no pain, 10 = worst possible pain)'}, {'measure': 'Median Time to Requiring Oral Opioids', 'timeFrame': '24 hours after the popliteal block is given', 'description': 'Did patient have pain requiring oral opioids?'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Postoperative Pain']}, 'referencesModule': {'references': [{'pmid': '25974277', 'type': 'DERIVED', 'citation': 'YaDeau JT, Paroli L, Fields KG, Kahn RL, LaSala VR, Jules-Elysee KM, Kim DH, Haskins SC, Hedden J, Goon A, Roberts MM, Levine DS. Addition of Dexamethasone and Buprenorphine to Bupivacaine Sciatic Nerve Block: A Randomized Controlled Trial. Reg Anesth Pain Med. 2015 Jul-Aug;40(4):321-9. doi: 10.1097/AAP.0000000000000254.'}]}, 'descriptionModule': {'briefSummary': 'This study looks at addition of medications to the local anesthetic for the nerve blockade.', 'detailedDescription': 'Following major foot and ankle surgery patients complain of severe pain. Currently, Hospital for Special Surgery (HSS) usually uses nerve blocks (injections of local anesthetic near nerves supplying the lower leg) to help manage pain after this type of surgery. Patients also receive additional pain pills, including narcotics as needed. This study looks at addition of medications to the local anesthetic for the nerve blockade. The investigators hope that these medications (dexamethasone and buprenorphine) will prolong the pain relief from the nerve block. There are 3 groups in the study. One group is a control, and receives usual therapy: nerve block + pain pills. This is typically what the patient would receive as standard care if they were not in the study. One group uses a nerve block with additives (+ pain pills). One group gets a nerve block (local anesthetic only) + pain pills + intravenous buprenorphine - this is meant to see if the buprenorphine acts directly on the nerve that was blocked, or indirectly acts on the brain.\n\nPatients will be followed while in the hospital, and contacted by telephone and/or email after discharge for 2-3 days. Patients will be asked about their pain levels and the duration of their block. The investigators will enroll 90 patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of Dr. Levine or Dr. Roberts at Hospital for Special Surgery\n* Patients aged 18-75\n* Patients scheduled for discharge from HSS after foot or ankle surgery\n* A single-injection popliteal fossa nerve block is judged appropriate\n* Surgery confined to foot and ankle (no iliac crest bone graft planned - iliac aspirate is not an exclusion criterion)\n\nExclusion Criteria:\n\n* \\< 18 and \\> 75\n* Surgery that will cause pain at sites outside the distal lower extremity (e.g. iliac crest bone graft)\n* Bilateral surgery\n* Chronic pain (defined as regular use of opioid analgesics for \\> 3 months)\n* Chronic use of steroids (defined as regular use of steroids for \\> 3 months)\n* Contraindication to performance of the popliteal fossa nerve block with 30 cc 0.25% bupivacaine (e.g. alleged bupivacaine sensitivity, low body weight, etc.)\n* Contraindications to dexamethasone or buprenorphine (e.g. allergy, insulin dependent diabetes mellitus, etc.)\n* Patients who have been diagnosed with altered pain perception or have lack of sensation\n* Inability of the patient to describe postoperative pain (e.g. psychiatric disorder, dementia)\n* Non-English speaking patients (the questionnaire is in English, and translations would have to be separately validated)'}, 'identificationModule': {'nctId': 'NCT02198235', 'briefTitle': 'Prolonged Popliteal Fossa Nerve Blockade (Prolonged Pop)', 'organization': {'class': 'OTHER', 'fullName': 'Hospital for Special Surgery, New York'}, 'officialTitle': 'Prolonged Popliteal Fossa Nerve Blockade', 'orgStudyIdInfo': {'id': '2012-017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control NB + IV Dex + IV Bup', 'description': 'IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg)', 'interventionNames': ['Drug: Dexamethasone', 'Drug: Buprenorphine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control NB + IV Dex', 'description': 'IV Dexamethasone (4 mg)', 'interventionNames': ['Drug: Dexamethasone']}, {'type': 'EXPERIMENTAL', 'label': 'NB with Dex + Bup in block.', 'description': 'Dexamethasone (4 mg) Buprenorphine (150 mcg)', 'interventionNames': ['Drug: Dexamethasone', 'Drug: Buprenorphine']}], 'interventions': [{'name': 'Dexamethasone', 'type': 'DRUG', 'armGroupLabels': ['Control NB + IV Dex', 'Control NB + IV Dex + IV Bup', 'NB with Dex + Bup in block.']}, {'name': 'Buprenorphine', 'type': 'DRUG', 'armGroupLabels': ['Control NB + IV Dex + IV Bup', 'NB with Dex + Bup in block.']}]}, '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': 'Jacques YaDeau, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital for Special Surgery, New York'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital for Special Surgery, New York', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}