Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2026-02-22 @ 9:39 AM
Study NCT ID:
NCT03349034
Status:
COMPLETED
Last Update Posted:
2020-11-17
First Post:
2017-11-17
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Local Infusion of Ropivacaine for Post-Op Pain Control After Osseocutaneous Free Flaps
Sponsor:
Organization:
Raw JSON
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A visual analogue pain scale is a validated pain measure. Essentially, there is a 100 millimeter line drawn on a piece of paper, with "no pain" marking the left end of the line and "worst pain" marking the right end of the line. Subjects mark with a pen along the line where pain is felt fits along that continuum. A researcher then measures how far along the line that mark is placed and then it is recorded. Full scale from 0-100, higher score indicates more pain.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Post-Operative Pain - Global Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Saline Placebo', 'description': 'Local Saline Infusion: Patients randomized to receive a local continuous infusion of 6 ml/hr of 0.9% normal saline via On-Q infusion pump, at the donor site, for the first 48 hours of the postoperative period.'}, {'id': 'OG001', 'title': 'Ropivacaine', 'description': 'Local Ropivicaine Infusion: Patients randomized to receive a local continuous infusion of 6 ml/hr of 0.2% Ropivacaine via On-Q infusion pump, at the donor site, for the first 48 hours of the postoperative period.'}], 'classes': [{'title': '8 hour', 'categories': [{'measurements': [{'value': '44.00', 'spread': '28.55', 'groupId': 'OG000'}, {'value': '40.14', 'spread': '32.25', 'groupId': 'OG001'}]}]}, {'title': '16 hour', 'categories': [{'measurements': [{'value': '27.50', 'spread': '23.18', 'groupId': 'OG000'}, {'value': '26.56', 'spread': '27.03', 'groupId': 'OG001'}]}]}, {'title': '24 hour', 'categories': [{'measurements': [{'value': '31.83', 'spread': '21.25', 'groupId': 'OG000'}, {'value': '41.56', 'spread': '30.33', 'groupId': 'OG001'}]}]}, {'title': '32 hour', 'categories': [{'measurements': [{'value': '24.17', 'spread': '25.91', 'groupId': 'OG000'}, {'value': '35.67', 'spread': '32.39', 'groupId': 'OG001'}]}]}, {'title': '40 hour', 'categories': [{'measurements': [{'value': '21.88', 'spread': '20.36', 'groupId': 'OG000'}, {'value': '33.60', 'spread': '28.76', 'groupId': 'OG001'}]}]}, {'title': '48 hour', 'categories': [{'measurements': [{'value': '20.38', 'spread': '13.43', 'groupId': 'OG000'}, {'value': '37.40', 'spread': '35.50', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8, 16, 24, 32, 40 and 48 hours', 'description': 'Pain assessed every 8 hours for the first 48 hours using a visual analogue pain scale at rest. A visual analogue pain scale is a validated pain measure. Essentially, there is a 100 millimeter line drawn on a piece of paper, with "no pain" marking the left end of the line and "worst pain" marking the right end of the line. Subjects mark with a pen along the line where pain is felt fits along that continuum. A researcher then measures how far along the line that mark is placed and then it is recorded. Full scale from 0-100, higher score indicates more pain.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Opioid Consumption', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Saline Placebo', 'description': 'Local Saline Infusion: Patients randomized to receive a local continuous infusion of 6 ml/hr of 0.9% normal saline via On-Q infusion pump, at the donor site, for the first 48 hours of the postoperative period.'}, {'id': 'OG001', 'title': 'Ropivacaine', 'description': 'Local Ropivicaine Infusion: Patients randomized to receive a local continuous infusion of 6 ml/hr of 0.2% Ropivacaine via On-Q infusion pump, at the donor site, for the first 48 hours of the postoperative period.'}], 'classes': [{'categories': [{'measurements': [{'value': '119.75', 'spread': '145.92', 'groupId': 'OG000'}, {'value': '91.20', 'spread': '132.14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 hours', 'description': 'All subjects receive standing tylenol 650mg every 6 hours as well as a dilaudid PCA set for low-dose, opioid-naive patients for the first 48 hours post-operatively. Total opioid consumption for each subject during the first 48 hours is recorded measured in oral morphine equivalents (OME).', 'unitOfMeasure': 'OME', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Range of Motion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Saline Placebo', 'description': 'Local Saline Infusion: Patients will be randomized to receive a local continuous infusion of 6 ml/hr of 0.9% normal saline via On-Q infusion pump, at the donor site, for the first 48 hours of the postoperative period.'}, {'id': 'OG001', 'title': 'Ropivacaine', 'description': 'Local Ropivicaine Infusion: Patients will be randomized to receive a local continuous infusion of 6 ml/hr of 0.2% Ropivacaine via On-Q infusion pump, at the donor site, for the first 48 hours of the postoperative period.'}], 'timeFrame': '48 hours', 'description': 'At 48 hours all subjects will receive a physical therapy evaluation. Range of motion will be measured in degrees', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected'}, {'type': 'SECONDARY', 'title': 'Distance Ambulated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Saline Placebo', 'description': 'Local Saline Infusion: Patients randomized to receive a local continuous infusion of 6 ml/hr of 0.9% normal saline via On-Q infusion pump, at the donor site, for the first 48 hours of the postoperative period.'}, {'id': 'OG001', 'title': 'Ropivacaine', 'description': 'Local Ropivicaine Infusion: Patients randomized to receive a local continuous infusion of 6 ml/hr of 0.2% Ropivacaine via On-Q infusion pump, at the donor site, for the first 48 hours of the postoperative period.'}], 'classes': [{'categories': [{'measurements': [{'value': '152', 'spread': '111.9', 'groupId': 'OG000'}, {'value': '80', 'spread': '67.08', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 hours', 'description': 'At 48 hours all subjects received a physical therapy evaluation. Distance ambulated measured in feet.', 'unitOfMeasure': 'feet', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Strength', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Saline Placebo', 'description': 'Local Saline Infusion: Patients randomized to receive a local continuous infusion of 6 ml/hr of 0.9% normal saline via On-Q infusion pump, at the donor site, for the first 48 hours of the postoperative period.'}, {'id': 'OG001', 'title': 'Ropivacaine', 'description': 'Local Ropivicaine Infusion: Patients randomized to receive a local continuous infusion of 6 ml/hr of 0.2% Ropivacaine via On-Q infusion pump, at the donor site, for the first 48 hours of the postoperative period.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.67', 'spread': '0.82', 'groupId': 'OG000'}, {'value': '2.20', 'spread': '1.10', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 hours', 'description': 'At 48 hours all subjects received a physical therapy evaluation. 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'8'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'catheters dislodged during transport', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'intubated for >48 hrs following surgery', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'soft tissue flap used', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants undergoing osseocutaneous fibula or scapular tip free flaps for head and neck reconstructionwere enrolled from September 2017 and September 2019.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Saline Placebo', 'description': 'Local Saline Infusion: Patients randomized to receive a local continuous infusion of 6 ml/hr of 0.9% normal saline via On-Q infusion pump, at the donor site, for the first 48 hours of the postoperative period.'}, {'id': 'BG001', 'title': 'Ropivacaine', 'description': 'Local Ropivicaine Infusion: Patients randomized to receive a local continuous infusion of 6 ml/hr of 0.2% Ropivacaine via On-Q infusion pump, at the donor site, for the first 48 hours of the postoperative period.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '65.1', 'spread': '11.6', 'groupId': 'BG000'}, {'value': '67.1', 'spread': '13.7', 'groupId': 'BG001'}, {'value': '66.2', 'spread': '12.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Body Mass Index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '27.2', 'spread': '4.81', 'groupId': 'BG000'}, {'value': '28.7', 'spread': '4.39', 'groupId': 'BG001'}, {'value': '28.0', 'spread': '4.51', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'ASA Physical Status Classification System', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2.88', 'spread': '0.35', 'groupId': 'BG000'}, {'value': '3.10', 'spread': '0.32', 'groupId': 'BG001'}, {'value': '3.0', 'spread': '0.34', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'American Society of Anesthesiologists Physical Status Classification I - A normal healthy patient II - A patient with mild systemic disease III - A patient with severe systemic disease IV - A patient with severe systemic disease that is a constant threat to life V - A moribund patient who is not expected to survive without the operation VI - A declared brain-dead patient whose organs are being removed for donor purposes', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Pack Years', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7.75', 'spread': '15.1', 'groupId': 'BG000'}, {'value': '7.30', 'spread': '10.1', 'groupId': 'BG001'}, {'value': '7.5', 'spread': '12.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'calculated by multiplying the number of packs of cigarettes smoked per day by the number of years the person has smoked.', 'unitOfMeasure': 'cigarettes per day for 1 year', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Smoking at Diagnosis', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of participants with Alcohol Abuse', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of participants with Diabetes Mellitus', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Tumor Type', 'classes': [{'title': 'squamous cell carcinoma (SCC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'Benign', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Primary Site/Procedure', 'classes': [{'title': 'Maxilla/Maxillectomy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Mandible/Mandibulectomy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Flap Type', 'classes': [{'title': 'Scapula', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'Fibula', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Previous Treatment', 'classes': [{'title': 'History of Radiation Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'History of Chemotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Length of Stay', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '11.5', 'spread': '3.89', 'groupId': 'BG000'}, {'value': '13.8', 'spread': '6.34', 'groupId': 'BG001'}, {'value': '12.8', 'spread': '5.37', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'days', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-09-19', 'size': 449810, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-09-29T18:47', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study is a double-blind prospective randomized placebo controlled trial wherein patients undergoing osseocutaneous free flap surgery are randomized to receive continuous infusion of Ropivacaine or normal saline (placebo) via local infusion catheter, which will be placed intraoperatively at the time of donor site closure. Outcomes are tracked and assessed for the first 48 hours post-operatively - median post-operative pain assessed via VAS every 8 hours, total analgesic used (all patients receive Tylenol 650 and dilaudid PCA post-operatively), physical therapy outcomes assessed on post-operative day two, and a patient satisfaction survey.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-26', 'studyFirstSubmitDate': '2017-11-17', 'resultsFirstSubmitDate': '2020-09-30', 'studyFirstSubmitQcDate': '2017-11-17', 'lastUpdatePostDateStruct': {'date': '2020-11-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-26', 'studyFirstPostDateStruct': {'date': '2017-11-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-11-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-Operative Pain at Donor-Site', 'timeFrame': '8, 16, 24, 32, 40 and 48 hours', 'description': 'Pain assessed every 8 hours for the first 48 hours using a visual analogue pain scale at rest. A visual analogue pain scale is a validated pain measure. Essentially, there is a 100 millimeter line drawn on a piece of paper, with "no pain" marking the left end of the line and "worst pain" marking the right end of the line. Subjects mark with a pen along the line where pain is felt fits along that continuum. A researcher then measures how far along the line that mark is placed and then it is recorded. Full scale from 0-100, higher score indicates more pain.'}, {'measure': 'Post-Operative Pain - Global Pain', 'timeFrame': '8, 16, 24, 32, 40 and 48 hours', 'description': 'Pain assessed every 8 hours for the first 48 hours using a visual analogue pain scale at rest. A visual analogue pain scale is a validated pain measure. Essentially, there is a 100 millimeter line drawn on a piece of paper, with "no pain" marking the left end of the line and "worst pain" marking the right end of the line. Subjects mark with a pen along the line where pain is felt fits along that continuum. A researcher then measures how far along the line that mark is placed and then it is recorded. Full scale from 0-100, higher score indicates more pain.'}], 'secondaryOutcomes': [{'measure': 'Opioid Consumption', 'timeFrame': '48 hours', 'description': 'All subjects receive standing tylenol 650mg every 6 hours as well as a dilaudid PCA set for low-dose, opioid-naive patients for the first 48 hours post-operatively. Total opioid consumption for each subject during the first 48 hours is recorded measured in oral morphine equivalents (OME).'}, {'measure': 'Range of Motion', 'timeFrame': '48 hours', 'description': 'At 48 hours all subjects will receive a physical therapy evaluation. Range of motion will be measured in degrees'}, {'measure': 'Distance Ambulated', 'timeFrame': '48 hours', 'description': 'At 48 hours all subjects received a physical therapy evaluation. Distance ambulated measured in feet.'}, {'measure': 'Strength', 'timeFrame': '48 hours', 'description': 'At 48 hours all subjects received a physical therapy evaluation. Strength measured on a standard neurological 5 point scale: 0 = Complete Paralysis to 5 = Normal Power.'}, {'measure': 'American Pain Society-Patient Outcome Questionnaire - (APS-POQ-R)', 'timeFrame': '48 hours', 'description': 'Pain question on APS-POQ-R - A standardized pain satisfaction survey distributed to subjects at 48 hours rating their overall satisfaction with postoperative pain management. a 16-item questions measured on a 10-point numeric likert scale, with higher scores indicating more pain. Total range from 0 (no pain) to 200 (severe pain).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Local anesthetics', 'Randomized Control Trial', 'Free tissue transfer', 'Head and neck', 'Microvascular', 'Postoperative Pain'], 'conditions': ['Head and Neck Cancer', 'Free Tissue Transfer']}, 'referencesModule': {'references': [{'pmid': '15681956', 'type': 'BACKGROUND', 'citation': 'Blumenthal S, Dullenkopf A, Rentsch K, Borgeat A. Continuous infusion of ropivacaine for pain relief after iliac crest bone grafting for shoulder surgery. Anesthesiology. 2005 Feb;102(2):392-7. doi: 10.1097/00000542-200502000-00023.'}, {'pmid': '23392233', 'type': 'BACKGROUND', 'citation': 'Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3.'}, {'pmid': '17341537', 'type': 'BACKGROUND', 'citation': 'Oderda GM, Said Q, Evans RS, Stoddard GJ, Lloyd J, Jackson K, Rublee D, Samore MH. Opioid-related adverse drug events in surgical hospitalizations: impact on costs and length of stay. Ann Pharmacother. 2007 Mar;41(3):400-6. doi: 10.1345/aph.1H386. Epub 2007 Mar 6.'}, {'pmid': '16284583', 'type': 'BACKGROUND', 'citation': 'Singh K, Samartzis D, Strom J, Manning D, Campbell-Hupp M, Wetzel FT, Gupta P, Phillips FM. A prospective, randomized, double-blind study evaluating the efficacy of postoperative continuous local anesthetic infusion at the iliac crest bone graft site after spinal arthrodesis. Spine (Phila Pa 1976). 2005 Nov 15;30(22):2477-83. doi: 10.1097/01.brs.0000186323.11285.b1.'}, {'pmid': '33619855', 'type': 'DERIVED', 'citation': 'Roof S, Ferrandino R, Eden C, Khelemsky Y, Teng M, Genden E, DeMaria S Jr, Miles BA. Local infusion of ropivacaine for pain control after osseous free flaps: Randomized controlled trial. Head Neck. 2021 Apr;43(4):1063-1072. doi: 10.1002/hed.26562. Epub 2021 Feb 23.'}]}, 'descriptionModule': {'briefSummary': 'Head and neck oncologic surgery often requires the use of free tissue transfer, or microvascular reconstruction, to reconstruct defects created by tumor resections. Although there are several techniques for the reconstruction of defects, resection of large tumors leave defects that require the transfer of vascularized tissue from one part of the body to repair the defect. For example, the removal of a segment of diseased mandible requires free tissue transfer containing the component parts - skin, muscle, and bone - to reconstruct the deficit created by the resection of the tumor. Over the years, microvascular surgeons have focused their attention on maximizing the success of these technically difficult surgeries. However, now, with free flap reconstruction rates in excess of 95%, surgeons are afforded the opportunity to turn their focus toward the morbidities associated with these surgeries. While much has been published about donor site wound healing, pain control in the post-operative period has largely been neglected in the head and neck reconstruction literature. Systemic analgesia with opioids is standard of care, which has been shown to lead to increased confusion, significantly increased length of stay and increased risk of pulmonary complications. In addition, it has been shown that early mobilization and optimal wound care can decrease donor site morbidity.\n\nIn this study the clinical team aims to better control donor site pain utilizing local, targeted analgesia to relieve pain at the donor site for osseocutaneous free-flaps. To reduce confounding and bias, the study will be a double-blind prospective randomized placebo controlled trial wherein patients undergoing osseocutaneous free flap surgery will be randomized to receive continuous infusion of ropivacaine or normal saline (placebo) via local continuous infusion catheter, which will be placed intraoperatively at the time of donor site closure. Patients\' pain will be monitored for the first 48hrs after surgery. Donor site and global pain at rest will be evaluated every 8 hours for the first two postoperative days using a visual analogue pain scale (VAS). Essentially, there is a 100 millimeter line drawn on a piece of paper, with "no pain" marking the left end of the line and "worst pain" marking the right end of the line. Subjects mark with a pen along the line where pain is felt fits along that continuum. A researcher then measures how far along the line that mark is placed and then it is recorded. Median daily opiate use via PCA will also be tracked. Donor site-specific range of motion and strength will be assessed with a formal physical therapy evaluation on post-operative day 2 or soonest non-holiday weekday. Information on patient satisfaction, time to ambulation, and length of stay will also be collected. Subgroup analysis will be performed.', 'detailedDescription': 'Procedures involved in this study include:\n\n\\- Intraoperatively, following procurement of the fibula or scapula bone graft and at the time of surgical wound closure, all patients will receive the placement of a continuous infusion catheter into the donor site wound bed. The infusion reservoir will be connected to a catheter-based On-Q pump, and the catheter will be placed in the donor site. A stab incision separate from the surgical wound will be used to bring the catheter through the skin. Patients will be randomized to receive 6 ml/hr of 0.2% Ropivacaine or 6 ml/hr of normal saline via the infusion reservoir. The catheter will be left in place with continuous infusion for first 48 hours of the post-operative period. The catheters will be removed by the housestaff on POD2. There is minimal risk to removing the OnQ catheter. Any opening in the skin will be covered with gauze to allow primary healing. Solutions of saline and ropivacaine will be prepared and made available for infusion by the Mount Sinai Pharmacy. Solutions will be blinded, and identical in appearance. Patients will be assigned to ropivacaine or saline intervention by the research pharmacy through coded envelopes. Patients, physicians, nurses, and research personnel will be blinded to treatment assignment. Every 8 hours for the first 48 hours, patients will be asked to complete a visual analogue scale (VAS) for reporting their pain. The VAS will be performed six times over the course of the 48hrs. These will be performed during regular flap check monitoring, to ensure patients are not disrupted additional times throughout the day for this study. Patients will otherwise receive standard of care pain management, including Tylenol 650 q6hr standing as well as a dilaudid PCA set to low-dose, opioid naïve. On post-operative day 2 patient will receive a physical therapy evaluation.\n\nPrior to discharge from the hospital, the study subjects will be asked to complete a brief survey (APS-POQ-R Pain Survey) regarding their experience, with regard to pain management.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients receiving osseocutaneous free tissue transfer regardless of the indication for free tissue transfer.\n\nThis includes osseocutaneous tissue from fibula and scapula\n\n* Age ≥ 18\n\nExclusion Criteria:\n\n* Patients unable to understand the research protocol and/or provide informed consent\n* Patients under the age of 18\n* Patients with a history of allergic reaction to Ropivacaine or other local amide anesthetics\n* Patients whose participation in this trial would require exclusion from participation in another clinical research trial related to the patient's malignant diagnosis.\n* Patients with previous pain disorders or drug abuse requiring chronic narcotic use.\n* Vulnerable populations (adults unable to consent, individuals who are not yet adults, wards of the state, prisoners)"}, 'identificationModule': {'nctId': 'NCT03349034', 'briefTitle': 'Local Infusion of Ropivacaine for Post-Op Pain Control After Osseocutaneous Free Flaps', 'organization': {'class': 'OTHER', 'fullName': 'Icahn School of Medicine at Mount Sinai'}, 'officialTitle': 'Role of Continuous Local Infusion of Ropivacaine for Post-Operative Pain Management in Patients Receiving Osseocutaneous Free Flaps', 'orgStudyIdInfo': {'id': 'GCO 17-1391'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test Group', 'description': 'Local Ropivicaine Infusion', 'interventionNames': ['Drug: Ropivicaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': 'Local Saline Infusion', 'interventionNames': ['Drug: Local Saline Infusion']}], 'interventions': [{'name': 'Ropivicaine', 'type': 'DRUG', 'description': 'Patients will be randomized to receive a local continuous infusion of 6 ml/hr of 0.2% Ropivacaine via On-Q infusion pump, at the donor site, for the first 48 hours of the postoperative period.', 'armGroupLabels': ['Test Group']}, {'name': 'Local Saline Infusion', 'type': 'DRUG', 'description': 'Patients will be randomized to receive a local continuous infusion of 6 ml/hr of 0.9% normal saline via On-Q infusion pump, at the donor site, for the first 48 hours of the postoperative period.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10129', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Eric Genden, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}, {'name': 'Brett Miles, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Icahn School of Medicine at Mount Sinai', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Brett Miles', 'investigatorAffiliation': 'Icahn School of Medicine at Mount Sinai'}}}}