Ignite Creation Date:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2026-01-01 @ 10:31 AM
Study NCT ID:
NCT05862792
Status:
RECRUITING
Last Update Posted:
2025-09-09
First Post:
2023-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Liposomal Bupivacaine and Transoral Robotic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009959', 'term': 'Oropharyngeal Neoplasms'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}], 'ancestors': [{'id': 'D010610', 'term': 'Pharyngeal Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'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'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-01-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-05', 'studyFirstSubmitDate': '2023-01-09', 'studyFirstSubmitQcDate': '2023-05-08', 'lastUpdatePostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative Pain Control', 'timeFrame': '3 months', 'description': "We will be measuring subjects' postoperative maximum visual analog pain scores on each postoperative day.\n\nScale: 0-10, 0 represents no pain and 10 represents the worst pain"}, {'measure': 'Postoperative Dysphagia with Endoscopic Swallow Study', 'timeFrame': '3 months', 'description': 'Patients will undergo a functional endoscopic swallow study with a speech language pathologist during their first postoperative visit.'}, {'measure': 'Postoperative Dysphagia with Dysphagia Survey', 'timeFrame': '3 months', 'description': 'Patients will undergo an evaluation of their swallow function via the MD Anderson Dysphagia Inventory survey with a speech language pathologist during their first postoperative visit.'}], 'secondaryOutcomes': [{'measure': 'Postoperative Pain Medication Usage', 'timeFrame': '3 months', 'description': 'We will be measuring the doses of pain medication that patients requiring during their postoperative course.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['oropharyngeal cancer', 'squamous cell carcinoma', 'postoperative pain', 'transoral robotic surgery'], 'conditions': ['Oropharyngeal Cancer', 'Dysphagia, Oropharyngeal', 'Post Operative Pain', 'Transoral Robotic Surgery']}, 'descriptionModule': {'briefSummary': 'This study is for patients with oropharyngeal squamous cell carcinoma. We want to learn more about how we can optimize pain control in patients who undergo transoral robotic surgery (TORS) for oropharyngeal squamous cell carcinoma. Our goal is to determine if a local anesthetic called EXPAREL® (Liposomal Bupivacaine) impacts postsurgical pain and swallow function in patients with oropharyngeal squamous cell carcinoma undergoing TORS. EXPAREL® is an FDA-approved anesthetic drug that provides long-lasting and precise pain relief when injected into the surgical wound. Our study team wants to determine if injecting EXPAREL® into the surgical wound will provide better pain relief and swallow function when compared to patients who do not undergo postoperative EXPAREL® injection. Both options for postoperative pain control are considered standard of care for patients undergoing TORS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients undergoing TORS', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients, greater than or equal to 18 years of age; Patients of all genders; Patients undergoing transoral robotic surgery; Patient who are able and willing to give consent\n\nExclusion Criteria:\n\n* Patients with an allergy to Bupivacaine or other amide anesthetics; Patients with a carnitine deficiency'}, 'identificationModule': {'nctId': 'NCT05862792', 'briefTitle': 'Liposomal Bupivacaine and Transoral Robotic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Geisinger Clinic'}, 'officialTitle': 'Impact of Liposomal Bupivacaine on Post-operative Pain, Opioid Use, and Swallow Function in Transoral Robotic Surgery', 'orgStudyIdInfo': {'id': '2022-0739'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'TORS + Liposomal Bupivacaine + Postoperative Antipyretics and Opioids Group', 'description': "Per standard of care, at the conclusion of the TORS procedure, liposomal bupivacaine will be injected into the surgical bed- (bupivacaine liposome suspension 1.3% \\[13.3 mg/mL\\], intramuscular) in this group. Possible injection sites include the base of tongue and/or tonsil. Total dose injected will be 3-4 mL. Subjects will also be given a pain regimen including:\n\n1. Tylenol 650 mg every 4 hours as needed for mild pain\n2. Oxycodone 5 mg every 4 hours as needed for moderate pain\n3. Morphine 2mg every 3 hours as needed for breakthrough pain\n\nThe treatment type (TORS +/- Liposomal Bupivacaine + Postoperative Antipyretics and Opioids) is determined by the subject's surgeon based on his standard practice.", 'interventionNames': ['Drug: Liposomal bupivacaine']}, {'label': 'TORS + Postoperative Antipyretics and Opioids Group', 'description': "Per standard of care, subjects in this group will only be given a pain regimen including:\n\n1. Tylenol 650 mg every 4 hours as needed for mild pain\n2. Oxycodone 5 mg every 4 hours as needed for moderate pain\n3. Morphine 2mg every 3 hours as needed for breakthrough pain\n\nThe treatment type (TORS +/- Liposomal Bupivacaine + Postoperative Antipyretics and Opioids) is determined by the subject's surgeon based on his standard practice."}], 'interventions': [{'name': 'Liposomal bupivacaine', 'type': 'DRUG', 'otherNames': ['EXPAREL'], 'description': 'We will inject liposomal bupivacaine into the surgical bed.', 'armGroupLabels': ['TORS + Liposomal Bupivacaine + Postoperative Antipyretics and Opioids Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17821', 'city': 'Danville', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Thorsen Haugen, MD', 'role': 'CONTACT', 'email': 'thaugen@geisinger.edu', 'phone': '570-214-7866'}], 'facility': 'Geisinger Medical Center', 'geoPoint': {'lat': 40.96342, 'lon': -76.61273}}], 'centralContacts': [{'name': 'Thorsen Haugen, MD', 'role': 'CONTACT', 'email': 'thaugen@geisinger.edu', 'phone': '570-214-7866'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Geisinger Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}