Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT05190120
Status:
COMPLETED
Last Update Posted:
2025-09-30
First Post:
2021-11-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Adductor Canal Block Versus Femoral Block on Pain and Quadriceps Strength
Sponsor:
Organization:
Raw JSON
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The dynamometer measures the strength of the quadriceps muscles in the seated position while pushing against the device. We are trying to measure the effect of both femoral and adductor canal nerve blocks on quadriceps strength.', 'unitOfMeasure': 'Newtons', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The participants with data available are reported here.'}, {'type': 'SECONDARY', 'title': 'Numerical Pain Score From 0-10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Femoral Block for Knee Arthroscopy/Meniscus Surgery', 'description': 'Patients scheduled for knee arthroscopy will have a femoral nerve block done using 0.5% ropivacaine 20ml before surgery.'}, {'id': 'OG001', 'title': 'Adductor Canal Block for Knee Arthroscopy/Meniscus Surgery', 'description': 'Patients scheduled for knee arthroscopy will have an adductor canal block done using 0.75% ropivacaine 13.3ml before surgery.'}, {'id': 'OG002', 'title': 'Femoral Block for ACL Reconstruction', 'description': 'Patients scheduled for ACL reconstruction will have a sciatic nerve block and a femoral nerve block done using 0.5% ropivacaine 20ml before surgery.'}, {'id': 'OG003', 'title': 'Adductor Canal Block for ACL Reconstruction', 'description': 'Patients scheduled for ACL reconstruction will have a sciatic nerve block and an adductor canal block done using 0.75% ropivacaine 13.3ml before surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '6.5'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '7'}, {'value': '7', 'groupId': 'OG002', 'lowerLimit': '4', 'upperLimit': '9'}, {'value': '6.5', 'groupId': 'OG003', 'lowerLimit': '5', 'upperLimit': '9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'worse pain in first 24 hours', 'description': 'As this is an outpatient surgery, we will collect Numerical Pain Scores from the recovery room medical record after surgery as well as from the patients for the first 24 hours after surgery by contacting them at home the following day. We will evaluate the difference in patient pain scores between the two nerve blocks under study.\n\nThe highest pain score for the 24-hour post-op period was collected for each participant. The median is reported for all participants. A pain score of 10 represents the worst pain.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The participants with data available are reported here.'}, {'type': 'SECONDARY', 'title': 'Duration of Nerve Block', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Femoral Block for Knee Arthroscopy/Meniscus Surgery', 'description': 'Patients scheduled for knee arthroscopy will have a femoral nerve block done using 0.5% ropivacaine 20ml before surgery.'}, {'id': 'OG001', 'title': 'Adductor Canal Block for Knee Arthroscopy/Meniscus Surgery', 'description': 'Patients scheduled for knee arthroscopy will have an adductor canal block done using 0.75% ropivacaine 13.3ml before surgery.'}, {'id': 'OG002', 'title': 'Femoral Block for ACL Reconstruction', 'description': 'Patients scheduled for ACL reconstruction will have a sciatic nerve block and a femoral nerve block done using 0.5% ropivacaine 20ml before surgery.'}, {'id': 'OG003', 'title': 'Adductor Canal Block for ACL Reconstruction', 'description': 'Patients scheduled for ACL reconstruction will have a sciatic nerve block and an adductor canal block done using 0.75% ropivacaine 13.3ml before surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '678', 'groupId': 'OG000', 'lowerLimit': '454', 'upperLimit': '903'}, {'value': '731', 'groupId': 'OG001', 'lowerLimit': '566', 'upperLimit': '896'}, {'value': '889', 'groupId': 'OG002', 'lowerLimit': '730', 'upperLimit': '1048'}, {'value': '923', 'groupId': 'OG003', 'lowerLimit': '755', 'upperLimit': '1091'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 to 24 hours', 'description': 'Patients will be contacted after surgery to determine when the nerve block wore off based on their increase in pain', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The participants with data available are reported here.'}, {'type': 'SECONDARY', 'title': 'Opioid Consumption Reported at mg of Morphine Equivalence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Femoral Block for Knee Arthroscopy/Meniscus Surgery', 'description': 'Patients scheduled for knee arthroscopy will have a femoral nerve block done using 0.5% ropivacaine 20ml before surgery.'}, {'id': 'OG001', 'title': 'Adductor Canal Block for Knee Arthroscopy/Meniscus Surgery', 'description': 'Patients scheduled for knee arthroscopy will have an adductor canal block done using 0.75% ropivacaine 13.3ml before surgery.'}, {'id': 'OG002', 'title': 'Femoral Block for ACL Reconstruction', 'description': 'Patients scheduled for ACL reconstruction will have a sciatic nerve block and a femoral nerve block done using 0.5% ropivacaine 20ml before surgery.'}, {'id': 'OG003', 'title': 'Adductor Canal Block for ACL Reconstruction', 'description': 'Patients scheduled for ACL reconstruction will have a sciatic nerve block and an adductor canal block done using 0.75% ropivacaine 13.3ml before surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000', 'lowerLimit': '30', 'upperLimit': '60'}, {'value': '51.25', 'groupId': 'OG001', 'lowerLimit': '40', 'upperLimit': '70'}, {'value': '20', 'groupId': 'OG002', 'lowerLimit': '10', 'upperLimit': '40'}, {'value': '20', 'groupId': 'OG003', 'lowerLimit': '15', 'upperLimit': '40'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '2 days', 'description': 'Data on the amount of pain medication consumed for the 1st 24 hours after surgery will be collected based on medications that were administered during surgery, in the recovery room and medications that patients took at home after discharge from the recovery room. All pain medications will be converted to morphine equivalence in milligrams and reported that way. The comparison will be the difference in mg morphine equivalence consumption between the two nerve block groups.', 'unitOfMeasure': 'Morphine milligram equivalents (MME)', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The participants with data available are reported here.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Femoral Block for Knee Arthroscopy/Meniscus Surgery', 'description': 'Patients scheduled for knee arthroscopy will have a femoral nerve block done using 0.5% ropivacaine 20ml before surgery.'}, {'id': 'FG001', 'title': 'Adductor Canal Block for Knee Arthroscopy/Meniscus Surgery', 'description': 'Patients scheduled for knee arthroscopy will have an adductor canal block done using 0.75% ropivacaine 13.3ml before surgery.'}, {'id': 'FG002', 'title': 'Femoral Block for ACL Reconstruction', 'description': 'Patients scheduled for ACL reconstruction will have a sciatic nerve block and a femoral nerve block 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'dropWithdraws': [{'type': 'Lost to follow up for primary outcome measurement d/t lack of time to complete before surgery', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '122', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Femoral Block for Knee Arthroscopy/Meniscus Surgery', 'description': 'Patients scheduled for knee arthroscopy will have a femoral nerve block done using 0.5% ropivacaine 20ml before surgery.'}, {'id': 'BG001', 'title': 'Adductor Canal Block for Knee Arthroscopy/Meniscus Surgery', 'description': 'Patients scheduled for knee arthroscopy will have an adductor canal block done using 0.75% ropivacaine 13.3ml before surgery.'}, {'id': 'BG002', 'title': 'Femoral Block for ACL Reconstruction', 'description': 'Patients scheduled for ACL reconstruction will have a sciatic nerve block and a femoral nerve block done using 0.5% ropivacaine 20ml before surgery.'}, {'id': 'BG003', 'title': 'Adductor Canal Block for ACL Reconstruction', 'description': 'Patients scheduled for ACL reconstruction will have a sciatic nerve block and an adductor canal block done using 0.75% ropivacaine 13.3ml before surgery.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000', 'lowerLimit': '33', 'upperLimit': '54'}, {'value': '49', 'groupId': 'BG001', 'lowerLimit': '35', 'upperLimit': '56'}, {'value': '35', 'groupId': 'BG002', 'lowerLimit': '28', 'upperLimit': '40'}, {'value': '33.5', 'groupId': 'BG003', 'lowerLimit': '25', 'upperLimit': '38'}, {'value': '36.5', 'groupId': 'BG004', 'lowerLimit': '29', 'upperLimit': '48'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '46', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '76', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '80', 'groupId': 'BG004'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '27', 'groupId': 'BG004'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}, {'title': 'Hispanic/Latino', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}]}]}, {'title': 'Native American or Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '24.3', 'groupId': 'BG000', 'lowerLimit': '22.4', 'upperLimit': '26.6'}, {'value': '28.3', 'groupId': 'BG001', 'lowerLimit': '24.2', 'upperLimit': '31.8'}, {'value': '25.4', 'groupId': 'BG002', 'lowerLimit': '23.5', 'upperLimit': '27.1'}, {'value': '24.4', 'groupId': 'BG003', 'lowerLimit': '22.8', 'upperLimit': '25.8'}, {'value': '25.3', 'groupId': 'BG004', 'lowerLimit': '23.0', 'upperLimit': '28.1'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'INTER_QUARTILE_RANGE'}], 'populationDescription': 'The data collection forms were missing for 10 participants. The data are not available to report, these data do not exist.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-03-20', 'size': 51618, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-03-20T14:42', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 132}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2022-03-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-16', 'studyFirstSubmitDate': '2021-11-16', 'resultsFirstSubmitDate': '2023-03-20', 'studyFirstSubmitQcDate': '2022-01-12', 'lastUpdatePostDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-09-16', 'studyFirstPostDateStruct': {'date': '2022-01-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-03-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Quadriceps Strength Related to the Nerve Block', 'timeFrame': 'Baseline and 20 minutes after the block prior to surgery', 'description': 'Quadriceps strength will be tested with a dynamometer before the nerve block and 20 minutes after the nerve block prior to surgery. The dynamometer measures the strength of the quadriceps muscles in the seated position while pushing against the device. We are trying to measure the effect of both femoral and adductor canal nerve blocks on quadriceps strength.'}], 'secondaryOutcomes': [{'measure': 'Numerical Pain Score From 0-10', 'timeFrame': 'worse pain in first 24 hours', 'description': 'As this is an outpatient surgery, we will collect Numerical Pain Scores from the recovery room medical record after surgery as well as from the patients for the first 24 hours after surgery by contacting them at home the following day. We will evaluate the difference in patient pain scores between the two nerve blocks under study.\n\nThe highest pain score for the 24-hour post-op period was collected for each participant. The median is reported for all participants. A pain score of 10 represents the worst pain.'}, {'measure': 'Duration of Nerve Block', 'timeFrame': '8 to 24 hours', 'description': 'Patients will be contacted after surgery to determine when the nerve block wore off based on their increase in pain'}, {'measure': 'Opioid Consumption Reported at mg of Morphine Equivalence', 'timeFrame': '2 days', 'description': 'Data on the amount of pain medication consumed for the 1st 24 hours after surgery will be collected based on medications that were administered during surgery, in the recovery room and medications that patients took at home after discharge from the recovery room. All pain medications will be converted to morphine equivalence in milligrams and reported that way. The comparison will be the difference in mg morphine equivalence consumption between the two nerve block groups.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Knee arthroscopy', 'ACL reconstruction', 'Femoral block', 'Adductor Canal Block'], 'conditions': ['Anterior Cruciate Ligament Tear', 'Knee Meniscus Tear']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the effects of a femoral nerve block vs. an adductor canal block on pain and quadriceps muscle strength for knee arthroscopy surgery.', 'detailedDescription': 'Patients undergoing arthroscopic knee surgery (ACL and non-ACL surgery) typically receive an ultrasound-guided femoral nerve block or an adductor canal block in the pre-operative phase for post-operative pain control. While an effective method for post-operative analgesia, the femoral nerve block is associated with profound quadriceps weakness for the duration of the nerve block, which can impair ambulation, rehabilitation, and increase the risk of falls. The more distal adductor canal block, however, contains primarily sensory branches of the femoral nerve and has been been purported by small volunteer studies to provide equally effective analgesia with minimal motor block and quadriceps weakness (as compared to femoral nerve block).\n\nThe investigators will prospectively randomize patients undergoing knee arthroscopy at the UCSF Orthopaedic Institute to receive either a single-shot femoral nerve or adductor canal block pre-operatively after taking baseline measurements of quadriceps strength (quantified by maximum voluntary isometric contraction). The quadriceps muscle strength will be checked 20 minutes after the nerve block to assess strength. All patients will subsequently undergo a general anesthetic. The primary outcome variable will be post-block quadriceps strength as a percentage of baseline from pre-block values. Secondary outcome variables that will also investigated include: VAS pain score in the post anesthesia recovery unit and post-operative day 1, duration of nerve blockade, and perioperative opioid consumption.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesia I-III classification,\n* Scheduled for arthroscopic knee surgery (meniscal debridement/repair, ACL reconstruction)\n\nExclusion Criteria:\n\n* Age younger than 18 years\n* Non-English speaking\n* Any contraindication for regional anesthesia, such as allergy to local anesthetics or opioids, -Coagulopaty or severe thrombocytopenia\n* Infection at puncture sites\n* Pre-existing neuropathy in operative limb\n* Need for post-operative nerve function monitoring\n* Dementia\n* Patient refusal\n* High pre-operative opioid requirements'}, 'identificationModule': {'nctId': 'NCT05190120', 'briefTitle': 'Adductor Canal Block Versus Femoral Block on Pain and Quadriceps Strength', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Effects of Ultrasound-guided Adductor Canal Block Versus Femoral Nerve Block on Pain and Quadriceps Strength After Ambulatory Knee Arthroscopic Surgery', 'orgStudyIdInfo': {'id': '14-13071'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Femoral Block', 'description': 'Patients scheduled for knee arthroscopy will have a femoral nerve block done using 0.5% ropivacaine 20ml before surgery.', 'interventionNames': ['Procedure: Femoral Nerve Block', 'Drug: preoperative Femoral Nerve Block using 20ml of 0.5% ropivacaine']}, {'type': 'EXPERIMENTAL', 'label': 'Adductor Canal Block', 'description': 'Patients scheduled for knee arthroscopy will have an adductor canal block done using 0.75% ropivacaine 13.3ml before surgery.', 'interventionNames': ['Procedure: Adductor Canal Nerve Block', 'Drug: Preoperative Adductor canal block with 0.75%% ropivacaine 13.3ml.']}], 'interventions': [{'name': 'Femoral Nerve Block', 'type': 'PROCEDURE', 'description': 'Patients having ACL reconstruction, meniscus surgery and knee arthroscopy', 'armGroupLabels': ['Femoral Block']}, {'name': 'Adductor Canal Nerve Block', 'type': 'PROCEDURE', 'description': 'Patients having ACL reconstruction, meniscus surgery and knee arthroscopy', 'armGroupLabels': ['Adductor Canal Block']}, {'name': 'preoperative Femoral Nerve Block using 20ml of 0.5% ropivacaine', 'type': 'DRUG', 'armGroupLabels': ['Femoral Block']}, {'name': 'Preoperative Adductor canal block with 0.75%% ropivacaine 13.3ml.', 'type': 'DRUG', 'armGroupLabels': ['Adductor Canal Block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Orthopedic Trauma Service', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Pedram Aleshi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will be shared only if required for the publication of data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}