Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2026-03-01 @ 10:06 AM
Study NCT ID:
NCT02376205
Status:
COMPLETED
Last Update Posted:
2020-02-13
First Post:
2015-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anesthetic to Reduce Dysphagia After Anterior Cervical Discectomy and Fusion Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003680', 'term': 'Deglutition Disorders'}], 'ancestors': [{'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D000077330', 'term': 'Saline Solution'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-03-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-11', 'studyFirstSubmitDate': '2015-02-17', 'studyFirstSubmitQcDate': '2015-02-25', 'lastUpdatePostDateStruct': {'date': '2020-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-03-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in dysphagia scores', 'timeFrame': '3 months', 'description': 'Swallowing-Quality of Life Questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anterior Cervical Discectomy and Fusion', 'Dysphagia'], 'conditions': ['Dysphagia']}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to analyze the effects of local anesthetic application into the retropharyngeal space and its ability to reduce dysphagia symptoms and/or occurrence rates in patients undergoing anterior cervical discectomy and fusion.', 'detailedDescription': 'The patients will be randomly assigned into one of the two groups to receive either bupivacaine hydrochloride 0.5% solution if they are randomized to the treatment group or 0.9% NaCl solution if they are randomized to the control group. These solutions will be poured into the retropharyngeal space intraoperatively before wound closure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients older than 18 y.o.\n* Patients undergoing one- or two-level anterior cervical discectomy and fusion surgery for radiculopathy or myelopathy symptoms\n* Patients are wiling and able to sign informed consent and complete questionnaires\n\nExclusion Criteria:\n\n* More than 2-level ACDF surgeries\n* Previous cervical spine surgery\n* Surgeries for trauma, infection or tumor\n* Known hypersensitivity reactions to bupivacaine hydrochloride or other amino-amide anesthetics (e.g. lidocaine)\n* Known history of swallowing issues (e.g. dysphagia, odynophagia)\n* Pregnant or breastfeeding'}, 'identificationModule': {'nctId': 'NCT02376205', 'briefTitle': 'Anesthetic to Reduce Dysphagia After Anterior Cervical Discectomy and Fusion Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Justin Parker Neurological Institute'}, 'officialTitle': 'The Effectiveness of Postoperative Local Retropharyngeal Space Anesthetic to Reduce Dysphagia After Anterior Cervical Discectomy and Fusion Surgery', 'orgStudyIdInfo': {'id': 'JPNI-4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'bupivacaine hydrochloride 0.5% solution', 'description': 'Bupivacaine hydrochloride 0.5% 10 mL solution poured into the retropharyngeal space intraoperatively before wound closure during anterior cervical discectomy and fusion procedure', 'interventionNames': ['Drug: bupivacaine hydrochloride 0.5% solution']}, {'type': 'PLACEBO_COMPARATOR', 'label': '0.9% NaCl solution', 'description': '0.9% NaCl 10 mL solution poured into the retropharyngeal space intraoperatively before wound closureduring anterior cervical discectomy and fusion procedure', 'interventionNames': ['Drug: 0.9% NaCl solution']}], 'interventions': [{'name': 'bupivacaine hydrochloride 0.5% solution', 'type': 'DRUG', 'otherNames': ['Marcaine'], 'description': '10mL will be poured into the retropharyngeal space intraoperatively during anterior cervical discectomy and fusion procedure', 'armGroupLabels': ['bupivacaine hydrochloride 0.5% solution']}, {'name': '0.9% NaCl solution', 'type': 'DRUG', 'otherNames': ['Saline'], 'description': '10mL will be poured into the retropharyngeal space intraoperatively during anterior cervical discectomy and fusion procedure', 'armGroupLabels': ['0.9% NaCl solution']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80303', 'city': 'Boulder', 'state': 'Colorado', 'country': 'United States', 'facility': 'Boulder Neurosurgical Associates', 'geoPoint': {'lat': 40.01499, 'lon': -105.27055}}], 'overallOfficials': [{'name': 'Alexander Mason, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Boulder Neurosurgical Associates'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Justin Parker Neurological Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}