Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2026-03-06 @ 7:06 AM
Study NCT ID:
NCT03844451
Status:
UNKNOWN
Last Update Posted:
2019-02-18
First Post:
2019-01-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enhanced Recovery With Liposomal Bupivacaine in Orthognathic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D000377', 'term': 'Agnosia'}], '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'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D004837', 'term': 'Epinephrine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D015306', 'term': 'Biogenic Monoamines'}, {'id': 'D001679', 'term': 'Biogenic Amines'}, {'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-05-17', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2019-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-14', 'studyFirstSubmitDate': '2019-01-17', 'studyFirstSubmitQcDate': '2019-02-14', 'lastUpdatePostDateStruct': {'date': '2019-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of hospitalization status post jaw surgery', 'timeFrame': 'Until discharge from hospital, an average of 3 days', 'description': 'The amount of time spent in the hospital after the surgery'}], 'secondaryOutcomes': [{'measure': 'Total morphine-equivalents', 'timeFrame': 'First 48 hours after surgery', 'description': 'Amount of morphine-equivalents consumed by patient'}, {'measure': 'Pain Scores', 'timeFrame': 'Until discharge from hospital, an average of 3 days', 'description': 'On a 1-10 visual analogue scale, measured per nursing with vital signs'}, {'measure': 'Oral intake', 'timeFrame': 'First 48 hours after surgery', 'description': 'Oral intake measured in cc'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Exparel, liposomal bupivacaine, postoperative, pain control'], 'conditions': ['Pain, Postoperative']}, 'descriptionModule': {'briefSummary': 'The proposed study design is a prospective, clinical trial comparing control group patients (CG; ncg = 30) that will undergo conventional perioperative management without an ERAS protocol and standard bupivacaine intraoperative nerve block to randomized treatment group patients that will receive an intraoperative V2 trigeminal nerve block using LB (TG; ntg = 30).', 'detailedDescription': "The proposed study design is a prospective, clinical trial comparing control group patients (CG; ncg = 30) that will undergo conventional perioperative management without an ERAS protocol and standard bupivacaine intraoperative nerve block to randomized treatment group patients that will receive an intraoperative V2 trigeminal nerve block using LB (TG; ntg = 30). The total study population size (N = 60) was determined by power analysis using a free online calculator for continuous variable comparison with two-sided equality. The hypotheses for this study is that a trigeminal nerve block LB-ERAS will confer better pain control to patients undergoing OGS compared to conventional bupivacaine and no ERAS protocol. We speculate that hospital stay, pain scores, duration to first postoperative oral intake, opioid pain medication requirements, and ORAE's will all be less in the TG than the CG. We postulate that the volume of oral nutrition tolerated in the first 48-hours postoperatively will be greater in the TG than the CG. Liposomal bupivacaine will be injected after a minimum of 20 minutes have passed since the pre-operative nerve block was administered. The patients' subjective pain experienced will be quantified by a traditional 10-point visual analogue score (VAS) in the post-anesthesia care unit (PACU), at time of admission to the post-operative recovery room, throughout the inpatient recovery period, and at time of discharge. The time to tolerance of first oral intake will be measured in hours. The amount of first-48-hour oral intake will be measured in milliliters (mL). We believe that a LB-ERAS protocol will result in lower necessary doses of opioid pain medications. This will be measured as first 48-hour total mg/kg dosage of opioid pain medication converted to oxycodone-equivalents by standard conversion ratios. The incidence of ORAE's will be tallied by the number of necessary prn doses of symptomatic management anti-pyretic and anti-nausea medications. We expect this to be lower in the TG. The degree of respiratory suppression will be measured by first 48-hour respiratory rate between CG and TG patients, which we expect to be lower in the CG relative to higher opioid pain medication totals."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* All patients undergoing orthognathic surgery at Dell Children's Medical Center will be intended for inclusion in the study.\n\nExclusion Criteria:\n\n* Only those patients with insufficient data in their medical records or contraindications to the administration of liposomal bupivacaine (hepatic disease or allergy to amide local anesthetics) will be excluded from the study."}, 'identificationModule': {'nctId': 'NCT03844451', 'briefTitle': 'Enhanced Recovery With Liposomal Bupivacaine in Orthognathic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas at Austin'}, 'officialTitle': 'ENHANCED RECOVERY AFTER ORTHOGNATHIC SURGERY USING LIPOSOMAL BUPIVACAINE: A RANDOMIZED CONTROL TRIAL', 'orgStudyIdInfo': {'id': '2018-09-0046'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Liposomal bupivicaine with nerve block', 'description': 'The treatment group will receive an intraoperative V2 trigeminal nerve block using liposomal bupivacaine in addition to a standard bupivacaine nerve block.', 'interventionNames': ['Drug: Liposomal Bupivacaine', 'Drug: Bupivacaine and Epinephrine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Nerve block only', 'description': 'The control group will undergo conventional perioperative management without an ERAS protocol and standard bupivacaine intraoperative nerve block.', 'interventionNames': ['Drug: Bupivacaine and Epinephrine']}], 'interventions': [{'name': 'Liposomal Bupivacaine', 'type': 'DRUG', 'description': 'At the conclusion of the procedure, liposomal bupivacaine will be administered as a V2 nerve block.', 'armGroupLabels': ['Liposomal bupivicaine with nerve block']}, {'name': 'Bupivacaine and Epinephrine', 'type': 'DRUG', 'description': 'At the start of the procedure, 0.5% bupivacaine and 1:200,000 epinephrine as a surgical field block.', 'armGroupLabels': ['Liposomal bupivicaine with nerve block', 'Nerve block only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78723', 'city': 'Austin', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kristopher Day, MD', 'role': 'CONTACT', 'email': 'kristophermday@gmail.com', 'phone': '319-601-9283'}], 'facility': "Dell Children's Medical Center", 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'centralContacts': [{'name': 'Kristopher Day, MD', 'role': 'CONTACT', 'email': 'kristophermday@gmail.com', 'phone': '3196019283'}, {'name': 'Raymond Harshbarger, MD', 'role': 'CONTACT', 'email': 'RJHarshbarger@ascension.org', 'phone': '(512) 324-0644'}], 'overallOfficials': [{'name': 'Kristopher Day, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Dell Children's Medical Center of Central Texas"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas at Austin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Kristopher Day', 'investigatorAffiliation': 'University of Texas at Austin'}}}}