Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2025-12-31 @ 8:56 PM
Study NCT ID:
NCT05368012
Status:
COMPLETED
Last Update Posted:
2025-04-15
First Post:
2022-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
MIDCAB (Mid-Calf Block) for Foot Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'popovicm@hss.edu', 'phone': '646-797-8948', 'title': 'MIDCAB (Mid-Calf Block) for foot surgery: A pilot study', 'organization': 'Hospital for Special Surgery'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Event Data was collected for 7 days post surgery', 'description': 'Adverse event collection was collected via phone call/patient reported', 'eventGroups': [{'id': 'EG000', 'title': 'Active MIDCAB', 'description': 'USG with a 25G needle, Bupivacaine 0.5% 30ml with 4mg preservative free dexamethasone divided as follows into the following 5 nerves: Posterior Tibial nerve (10ml), Saphenous nerve (5ml), Deep peroneal Nerve (5ml), Superficial peroneal nerve (5 ml), and Sural Nerve (5ml).\n\nMIDCAB: Ultrasound-guided administration of the nerve block MIDCAB into mid-calf as analgesic intervention for patients.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Block Duration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Active MIDCAB', 'description': 'USG with a 25G needle, Bupivacaine 0.5% 30ml with 4mg preservative free dexamethasone divided as follows into the following 5 nerves: Posterior Tibial nerve (10ml), Saphenous nerve (5ml), Deep peroneal Nerve (5ml), Superficial peroneal nerve (5 ml), and Sural Nerve (5ml).\n\nMIDCAB: Ultrasound-guided administration of the nerve block MIDCAB into mid-calf as analgesic intervention for patients.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.2', 'groupId': 'OG000', 'lowerLimit': '4.5', 'upperLimit': '24.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Out to 1 week postoperatively', 'description': "The primary outcome will be block duration, how long the MIDCAB block provides analgesia. This will be measured via questionnaires of pain scores given to patients post surgical discharge (in PACU), 24h post surgical discharge, 48 hours post surgical discharge, and 1 week post surgical discharge. This will be done by measuring the change in patient's pains scores over the course of 7 days. Pain scores will be measured via NRS pain scale; the NRS (numeric rating scale) is a questionnaire that measures pain on a numeric scale, 0 (no pain) to 10 (worst pain imaginable). Patients will be asked to state the specific time-points they began to have pain after surgery.", 'unitOfMeasure': 'hours', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Return of Motor Function of Foot and Ankle Post-Operatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Active MIDCAB', 'description': 'USG with a 25G needle, Bupivacaine 0.5% 30ml with 4mg preservative free dexamethasone divided as follows into the following 5 nerves: Posterior Tibial nerve (10ml), Saphenous nerve (5ml), Deep peroneal Nerve (5ml), Superficial peroneal nerve (5 ml), and Sural Nerve (5ml).\n\nMIDCAB: Ultrasound-guided administration of the nerve block MIDCAB into mid-calf as analgesic intervention for patients.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Measured in the PACU (post-anesthesia care unit) immediately upon patients arrival into the PACU, up to 1 hour after surgery.', 'description': "The return of the patient's foot/ankle motor function which will be measured by whether the patient can dorsiflex/plantarflex at the ankle or have flexion/extension of the toes.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cumulative Opioid Consumption', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Active MIDCAB', 'description': 'USG with a 25G needle, Bupivacaine 0.5% 30ml with 4mg preservative free dexamethasone divided as follows into the following 5 nerves: Posterior Tibial nerve (10ml), Saphenous nerve (5ml), Deep peroneal Nerve (5ml), Superficial peroneal nerve (5 ml), and Sural Nerve (5ml).\n\nMIDCAB: Ultrasound-guided administration of the nerve block MIDCAB into mid-calf as analgesic intervention for patients'}], 'classes': [{'title': 'PACU', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '7.5'}]}]}, {'title': 'POD1', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '33.8'}]}]}, {'title': 'POD2', 'categories': [{'measurements': [{'value': '8.8', 'groupId': 'OG000', 'lowerLimit': '3.8', 'upperLimit': '27'}]}]}, {'title': 'POD7', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000', 'lowerLimit': '7.5', 'upperLimit': '67.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': "PACU (up until patients' discharge from the hospital), POD1 (Around 24 hrs after the PACU arrival time), POD2 (Around 48 hrs after the PACU arrival time) & POD7 (Around 1 week from the PACU arrival time)", 'description': 'Cumulative opioid consumption in morphine equivalents will be recorded post surgical discharge (in PACU), 24h post surgical discharge, 48 hours post surgical discharge, and 1 week post surgical discharge.', 'unitOfMeasure': 'mg oral morphine equivalents', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Presence of Paresthesia (Numbness)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Active MIDCAB', 'description': 'USG with a 25G needle, Bupivacaine 0.5% 30ml with 4mg preservative free dexamethasone divided as follows into the following 5 nerves: Posterior Tibial nerve (10ml), Saphenous nerve (5ml), Deep peroneal Nerve (5ml), Superficial peroneal nerve (5 ml), and Sural Nerve (5ml).\n\nMIDCAB: Ultrasound-guided administration of the nerve block MIDCAB into mid-calf as analgesic intervention for patients.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'POD 7 (1 week post-surgical discharge)', 'description': 'Patients will be asked if they have any residual numbness in the foot or toes where the surgery took place.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Presence of Skin Irritation and Wounds', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Active MIDCAB', 'description': 'USG with a 25G needle, Bupivacaine 0.5% 30ml with 4mg preservative free dexamethasone divided as follows into the following 5 nerves: Posterior Tibial nerve (10ml), Saphenous nerve (5ml), Deep peroneal Nerve (5ml), Superficial peroneal nerve (5 ml), and Sural Nerve (5ml).\n\nMIDCAB: Ultrasound-guided administration of the nerve block MIDCAB into mid-calf as analgesic intervention for patients.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'POD 7 (1 week post-surgical discharge)', 'description': 'Patients will be asked if they have any wounds or irritation to the skin (i.e. rashes, itching, burning, etc.) on the skin at the site of surgery and/or site of the block.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Presence of Nausea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Active MIDCAB', 'description': 'USG with a 25G needle, Bupivacaine 0.5% 30ml with 4mg preservative free dexamethasone divided as follows into the following 5 nerves: Posterior Tibial nerve (10ml), Saphenous nerve (5ml), Deep peroneal Nerve (5ml), Superficial peroneal nerve (5 ml), and Sural Nerve (5ml).\n\nMIDCAB: Ultrasound-guided administration of the nerve block MIDCAB into mid-calf as analgesic intervention for patients.'}], 'classes': [{'title': 'PACU', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'POD1', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'POD2', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'POD7', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': "PACU (up until patients' discharge from the hospital), POD1 (Around 24 hrs after the PACU arrival time), POD2 (Around 48 hrs after the PACU arrival time) & POD7 (Around 1 week from the PACU arrival time)", 'description': 'The questionnaire used asks patients if they have experienced any nausea.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Severity of Nausea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Active MIDCAB', 'description': 'USG with a 25G needle, Bupivacaine 0.5% 30ml with 4mg preservative free dexamethasone divided as follows into the following 5 nerves: Posterior Tibial nerve (10ml), Saphenous nerve (5ml), Deep peroneal Nerve (5ml), Superficial peroneal nerve (5 ml), and Sural Nerve (5ml).\n\nMIDCAB: Ultrasound-guided administration of the nerve block MIDCAB into mid-calf as analgesic intervention for patients.'}], 'classes': [{'title': 'PACU', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '3'}]}]}, {'title': 'POD1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '7'}]}]}, {'title': 'POD2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.67', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '5'}]}]}, {'title': 'POD7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '3'}]}]}], 'paramType': 'MEAN', 'timeFrame': "PACU (up until patients' discharge from the hospital), POD1 (Around 24 hrs after the PACU arrival time), POD2 (Around 48 hrs after the PACU arrival time) & POD7 (Around 1 week from the PACU arrival time)", 'description': 'Patients are asked on a scale from 0-10 (0 being not severe and 10 being the worst severity) how severe their nausea was. This will be measured post surgical discharge (in PACU), 24h post surgical discharge, 48 hours post surgical discharge, and 1 week post surgical discharge', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The number analyzed is different than the overall number analyzed due to the fact that not every patient experienced any nausea. Only the patients who experienced nausea then got the follow up question about the severity of it.'}, {'type': 'SECONDARY', 'title': 'Number of Total Episodes of Nausea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Active MIDCAB', 'description': 'USG with a 25G needle, Bupivacaine 0.5% 30ml with 4mg preservative free dexamethasone divided as follows into the following 5 nerves: Posterior Tibial nerve (10ml), Saphenous nerve (5ml), Deep peroneal Nerve (5ml), Superficial peroneal nerve (5 ml), and Sural Nerve (5ml).\n\nMIDCAB: Ultrasound-guided administration of the nerve block MIDCAB into mid-calf as analgesic intervention for patients.'}], 'classes': [{'title': 'PACU', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '1'}]}]}, {'title': 'POD1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '3'}]}]}, {'title': 'POD2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.33', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '2'}]}]}, {'title': 'POD7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '2'}]}]}], 'paramType': 'MEAN', 'timeFrame': "PACU (up until patients' discharge from the hospital), POD1 (Around 24 hrs after the PACU arrival time), POD2 (Around 48 hrs after the PACU arrival time) & POD7 (Around 1 week from the PACU arrival time)", 'description': 'Patients were asked how many episodes of nausea had occurred.', 'unitOfMeasure': 'episodes', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The number analyzed is different than the overall number analyzed due to the fact that not every patient experienced any nausea. Only the patients who experienced nausea then got the follow up question about the severity of it.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment', 'description': 'A total of 20 patients will be enrolled and will receive the stand of care analgesic protocol in addition to the following MIDCAB nerve block. There is only one treatment group in this study, no placebo group. The rationale behind there being one group is that this is a small pilot study that intends to inform subsequent randomized clinical control trials.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Active MIDCAB', 'description': 'USG with a 25G needle, Bupivacaine 0.5% 30ml with 4mg preservative free dexamethasone divided as follows into the following 5 nerves: Posterior Tibial nerve (10ml), Saphenous nerve (5ml), Deep peroneal Nerve (5ml), Superficial peroneal nerve (5 ml), and Sural Nerve (5ml).\n\nMIDCAB: Ultrasound-guided administration of the nerve block MIDCAB into mid-calf as analgesic intervention for patients.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.1', 'spread': '13.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-05-03', 'size': 360227, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-02-11T10:09', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All participants will receive the active MIDCAB block.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2022-11-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-31', 'studyFirstSubmitDate': '2022-03-29', 'resultsFirstSubmitDate': '2025-02-11', 'studyFirstSubmitQcDate': '2022-05-05', 'lastUpdatePostDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-31', 'studyFirstPostDateStruct': {'date': '2022-05-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Block Duration', 'timeFrame': 'Out to 1 week postoperatively', 'description': "The primary outcome will be block duration, how long the MIDCAB block provides analgesia. This will be measured via questionnaires of pain scores given to patients post surgical discharge (in PACU), 24h post surgical discharge, 48 hours post surgical discharge, and 1 week post surgical discharge. This will be done by measuring the change in patient's pains scores over the course of 7 days. Pain scores will be measured via NRS pain scale; the NRS (numeric rating scale) is a questionnaire that measures pain on a numeric scale, 0 (no pain) to 10 (worst pain imaginable). Patients will be asked to state the specific time-points they began to have pain after surgery."}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Return of Motor Function of Foot and Ankle Post-Operatively', 'timeFrame': 'Measured in the PACU (post-anesthesia care unit) immediately upon patients arrival into the PACU, up to 1 hour after surgery.', 'description': "The return of the patient's foot/ankle motor function which will be measured by whether the patient can dorsiflex/plantarflex at the ankle or have flexion/extension of the toes."}, {'measure': 'Cumulative Opioid Consumption', 'timeFrame': "PACU (up until patients' discharge from the hospital), POD1 (Around 24 hrs after the PACU arrival time), POD2 (Around 48 hrs after the PACU arrival time) & POD7 (Around 1 week from the PACU arrival time)", 'description': 'Cumulative opioid consumption in morphine equivalents will be recorded post surgical discharge (in PACU), 24h post surgical discharge, 48 hours post surgical discharge, and 1 week post surgical discharge.'}, {'measure': 'Presence of Paresthesia (Numbness)', 'timeFrame': 'POD 7 (1 week post-surgical discharge)', 'description': 'Patients will be asked if they have any residual numbness in the foot or toes where the surgery took place.'}, {'measure': 'Presence of Skin Irritation and Wounds', 'timeFrame': 'POD 7 (1 week post-surgical discharge)', 'description': 'Patients will be asked if they have any wounds or irritation to the skin (i.e. rashes, itching, burning, etc.) on the skin at the site of surgery and/or site of the block.'}, {'measure': 'Presence of Nausea', 'timeFrame': "PACU (up until patients' discharge from the hospital), POD1 (Around 24 hrs after the PACU arrival time), POD2 (Around 48 hrs after the PACU arrival time) & POD7 (Around 1 week from the PACU arrival time)", 'description': 'The questionnaire used asks patients if they have experienced any nausea.'}, {'measure': 'Severity of Nausea', 'timeFrame': "PACU (up until patients' discharge from the hospital), POD1 (Around 24 hrs after the PACU arrival time), POD2 (Around 48 hrs after the PACU arrival time) & POD7 (Around 1 week from the PACU arrival time)", 'description': 'Patients are asked on a scale from 0-10 (0 being not severe and 10 being the worst severity) how severe their nausea was. This will be measured post surgical discharge (in PACU), 24h post surgical discharge, 48 hours post surgical discharge, and 1 week post surgical discharge'}, {'measure': 'Number of Total Episodes of Nausea', 'timeFrame': "PACU (up until patients' discharge from the hospital), POD1 (Around 24 hrs after the PACU arrival time), POD2 (Around 48 hrs after the PACU arrival time) & POD7 (Around 1 week from the PACU arrival time)", 'description': 'Patients were asked how many episodes of nausea had occurred.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['foot and ankle surgery'], 'conditions': ['Ankle Surgery', 'Foot Surgery']}, 'descriptionModule': {'briefSummary': 'MIDCAB is defined as a group of ultrasound guided distal nerve blocks at the level of the individual branches. It is similar to an Ultrasound Guided (USG) Ankle block but the probe is placed higher on the calf covering all and any surgery of the foot and ankle, providing prolonged analgesia since we are blocking the individual nerves and preserving the proximal motor function.\n\nThis study is determining the potential therapeutic effect of MIDCAB during the hospital stay and recovery period in patients undergoing foot/ankle surgeries that require spinal anesthetic and peripheral nerve blocks. A total of 20 patients at HSS will participate to see if MIDCAB is not only effective at providing analgesia (pain relief) but to see if it allows allows patients to maintain motor function (movement) of the foot and ankle unlike the current popliteal block which is done above the knee and prevents patients from moving their foot.\n\nDuring the course of the study we will also be looking at patients numeric pain scores with movement and at rest along with post-operative nausea and vomiting, the presence of numbness and it patients can move their foot. Along with all of these, the study will also look at the amount of opioid pain medications taken by patients along with medication-related side effects. As a result, the study will be used to determine if MIDCAB provides analgesia for patients undergoing foot/ankle surgery while allowing them to maintain movement of the foot. This pilot study will also be used to gather preliminary data that will allow us to perform a power analysis for a subsequent randomized clinical control trial that would compare the MIDCAB block to the popliteal block.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Planned use of regional anesthesia\n* Ability to follow the major components of the study protocol\n* Planned foot or angle surgery\n\nExclusion Criteria:\n\n* Patients younger than 18 years old and older than 80 years old\n* Patients intending to receive general anesthesia\n* Contra-indication to nerve blocks or spinal anesthesia\n* Patients with an ASA status of IV or higher\n* Chronic opioid use (taking opioids for longer than 3 months)\n* Patients with prior foot or ankle surgery\n* Patients with type 2 diabetes'}, 'identificationModule': {'nctId': 'NCT05368012', 'acronym': 'MIDCAB', 'briefTitle': 'MIDCAB (Mid-Calf Block) for Foot Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Hospital for Special Surgery, New York'}, 'officialTitle': 'MIDCAB (Mid-Calf Block) for Foot Surgery: A Pilot Study', 'orgStudyIdInfo': {'id': '2022-0066'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Active MIDCAB', 'description': 'USG with a 25G needle, Bupivacaine 0.5% 30ml with 4mg preservative free dexamethasone divided as follows into the following 5 nerves: Posterior Tibial nerve (10ml), Saphenous nerve (5ml), Deep peroneal Nerve (5ml), Superficial peroneal nerve (5 ml), and Sural Nerve (5ml).', 'interventionNames': ['Drug: MIDCAB']}], 'interventions': [{'name': 'MIDCAB', 'type': 'DRUG', 'otherNames': ['Bupivacaine and dexamethasone'], 'description': 'Ultrasound-guided administration of the nerve block MIDCAB into mid-calf as analgesic intervention for patients.', 'armGroupLabels': ['Active MIDCAB']}]}, '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': 'Enrique Goytizolo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital for Special Surgery, New York'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Beginning 9 months and ending 36 months following article publication.', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results reported in this article after de-identification (text, tables, figures, and appendices).', 'accessCriteria': 'Investigators whose proposed use of the data has been approved by an Independent review committee ("learned intermediary") identified for this purpose and who have signed a DUA.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital for Special Surgery, New York', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}