Ignite Creation Date:
2025-12-24 @ 3:34 PM
Ignite Modification Date:
2026-01-05 @ 5:43 PM
Study NCT ID:
NCT06465992
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-06-20
First Post:
2024-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Liposomal Bupivacaine With Dexamethasone for Foot Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'D007267', 'term': 'Injections'}, {'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 126}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-06-17', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-14', 'studyFirstSubmitDate': '2024-06-14', 'studyFirstSubmitQcDate': '2024-06-14', 'lastUpdatePostDateStruct': {'date': '2024-06-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amount of pain medication used after surgery', 'timeFrame': '14 days', 'description': 'Collected as tablets taken since all participants will be prescribed oxycodone'}, {'measure': 'Pain level after surgery', 'timeFrame': '14 days', 'description': 'Participants will be asked daily what their pain levels are using the Visual Analog (VAS) pain scale'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Foot Surgery', 'Ankle Surgery', 'Post Operative Pain', 'Popliteal Nerve Block']}, 'descriptionModule': {'briefSummary': 'This study aims to understand the ideal formulation to utilize in saphenous nerve and popliteal nerve blocks for foot and ankle procedures. It will examine the use of liposomal bupivacaine alone or liposomal bupivacaine with dexamethasone prior to foot and ankle procedures in peripheral nerve blocks. We will compare liposomal bupivacaine (Exparel) and liposomal bupivacaine (Exparel) combined with dexamethasone to determine if the addition of dexamethasone significantly decreases postoperative narcotic use and prolongs analgesic effects when administered in a popliteal and saphenous block prior to foot and ankle orthopedic procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants with foot and ankle procedures at Jefferson Surgery Center, Navy Yard\n* Participants with foot and ankle orthopedic procedures requiring a preoperative nerve block\n* Age 18 and older\n* English speaking\n* Ability to complete surveys by phone or in person\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Revision foot and ankle cases\n* Allergies to study medications\n* Non-English speakers\n* Known alcohol or narcotic abuse history\n* Existing contract with a pain specialist due to underlying preoperative pain syndrome\n* Preoperative opioid use within the 3 months prior to surgery\n* Participants who are pregnant, plan to become pregnant, or are breastfeeding.'}, 'identificationModule': {'nctId': 'NCT06465992', 'briefTitle': 'Liposomal Bupivacaine With Dexamethasone for Foot Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Rothman Institute Orthopaedics'}, 'officialTitle': 'Single-Shot Liposomal Bupivacaine vs. Liposomal Bupivacaine Combined With Dexamethasone Prior to Foot and Ankle Procedures: A Prospective Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'DPED20242471'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Study Group 1: Foot/Ankle Surgery with Exparel Nerve Block', 'description': 'Prior to participants surgical procedure, the anesthesiologist will administer a popliteal and saphenous nerve block consisting of 20 mL Liposomal bupivacaine (Exparel) + 10 mL of 0.75% bupivacaine', 'interventionNames': ['Drug: Exparel 266 MG Per 20 ML Injection', 'Drug: Bupivacaine Hcl 0.75% Inj']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Study Group 2: Foot/Ankle Surgery with Exparel + Dexamethasone Nerve Block', 'description': "Prior to participants surgical procedure, the anesthesiologist will administer a popliteal and saphenous nerve block consisting of 20 mL Liposomal bupivacaine (Exparel) + 1 mL of 10 mg preservative free Dexamethasone + 10 cc's of 0.75% bupivacaine", 'interventionNames': ['Drug: Exparel 266 MG Per 20 ML Injection', 'Drug: Bupivacaine Hcl 0.75% Inj', 'Drug: Dexamethasone']}], 'interventions': [{'name': 'Exparel 266 MG Per 20 ML Injection', 'type': 'DRUG', 'description': '20 mL Liposomal bupivacaine (Exparel, 266 mg) will be administered in the popliteal and saphenous block', 'armGroupLabels': ['Study Group 1: Foot/Ankle Surgery with Exparel Nerve Block', 'Study Group 2: Foot/Ankle Surgery with Exparel + Dexamethasone Nerve Block']}, {'name': 'Bupivacaine Hcl 0.75% Inj', 'type': 'DRUG', 'description': '10 mL of 0.75% bupivacaine will be administered in popliteal and saphenous block', 'armGroupLabels': ['Study Group 1: Foot/Ankle Surgery with Exparel Nerve Block', 'Study Group 2: Foot/Ankle Surgery with Exparel + Dexamethasone Nerve Block']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'description': '1 mL of 10 mg Dexamethasone will be administered in the popliteal and saphenous block', 'armGroupLabels': ['Study Group 2: Foot/Ankle Surgery with Exparel + Dexamethasone Nerve Block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Rothman Orthopaedic Institute', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rothman Institute Orthopaedics', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}