Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2026-01-01 @ 8:57 AM
Study NCT ID:
NCT04421092
Status:
COMPLETED
Last Update Posted:
2025-10-23
First Post:
2020-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy of SLN Block for Chronic Cough
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-01-18', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003371', 'term': 'Cough'}, {'id': 'D000096822', 'term': 'Chronic Cough'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D014221', 'term': 'Triamcinolone'}, {'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D004837', 'term': 'Epinephrine'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'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'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nguyensh@musc.edu', 'phone': '8437921356', 'title': 'Shaun A. Nguyen, MD - Director of Clinical Research', 'organization': 'Medical University of South Carolina - Department of Otolaryngology'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 year and 6 months', 'description': 'This is a routine procedure done by laryngologists.', 'eventGroups': [{'id': 'EG000', 'title': 'Steroid-Lidocaine Mixture', 'description': 'Will receive numbing injection, which is a mixture of steroid and lidocaine\n\nSuperior laryngeal nerve block: Injection of either the steroid-lidocaine mixture or placebo through the skin around where the superior laryngeal nerve is located on the neck. The procedure lasts 5 minutes and is done in the clinic.\n\nInjection of steroid-lidocaine mixture: Superior laryngeal nerve block using 1mg 1:1 triamcinolone 40mg: 1% lidocaine with 1:200000 epinephrine as the injection.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 3, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Will receive saline injection as a placebo\n\nSuperior laryngeal nerve block: Injection of either the steroid-lidocaine mixture or placebo through the skin around where the superior laryngeal nerve is located on the neck. The procedure lasts 5 minutes and is done in the clinic.\n\nInjection of placebo (saline): Superior laryngeal nerve block using 1mL of saline as the injection.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 1, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Mild transient soreness at injection site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Cough Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Steroid-Lidocaine Mixture', 'description': 'Will receive numbing injection, which is a mixture of steroid and lidocaine\n\nSuperior laryngeal nerve block: Injection of either the steroid-lidocaine mixture or placebo through the skin around where the superior laryngeal nerve is located on the neck. The procedure lasts 5 minutes and is done in the clinic.\n\nInjection of steroid-lidocaine mixture: Superior laryngeal nerve block using 1mg 1:1 triamcinolone 40mg: 1% lidocaine with 1:200000 epinephrine as the injection.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Will receive saline injection as a placebo\n\nSuperior laryngeal nerve block: Injection of either the steroid-lidocaine mixture or placebo through the skin around where the superior laryngeal nerve is located on the neck. The procedure lasts 5 minutes and is done in the clinic.\n\nInjection of placebo (saline): Superior laryngeal nerve block using 1mL of saline as the injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.15', 'spread': '4.52', 'groupId': 'OG000'}, {'value': '9.54', 'spread': '3.87', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to 3 months', 'description': 'Patient will complete the Leicester Cough Questionnaire at each visit. This is a validated survey that measures 3 domains (physical, psychological and social). The total score range is 3-21 and domain scores range from 1-7; a higher score indicates a better quality of life.', 'unitOfMeasure': 'LCQ scores (baseline to 3 months)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Subjective Improvement in Cough', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Steroid-Lidocaine Mixture', 'description': 'Will receive numbing injection, which is a mixture of steroid and lidocaine\n\nSuperior laryngeal nerve block: Injection of either the steroid-lidocaine mixture or placebo through the skin around where the superior laryngeal nerve is located on the neck. The procedure lasts 5 minutes and is done in the clinic.\n\nInjection of steroid-lidocaine mixture: Superior laryngeal nerve block using 1mg 1:1 triamcinolone 40mg: 1% lidocaine with 1:200000 epinephrine as the injection.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Will receive saline injection as a placebo\n\nSuperior laryngeal nerve block: Injection of either the steroid-lidocaine mixture or placebo through the skin around where the superior laryngeal nerve is located on the neck. The procedure lasts 5 minutes and is done in the clinic.\n\nInjection of placebo (saline): Superior laryngeal nerve block using 1mL of saline as the injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, 1-4 weeks post-injection, and 3 months post-treatment', 'description': "Improvement was defined as a 'yes' response at any time point during the study (1-4 weeks or 3 months post-treatment). The reported value reflects the total number of participants who reported improvement at any time point.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Summed Daily Change in Subjective Cough Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Steroid-Lidocaine Mixture', 'description': 'Will receive numbing injection, which is a mixture of steroid and lidocaine\n\nSuperior laryngeal nerve block: Injection of either the steroid-lidocaine mixture or placebo through the skin around where the superior laryngeal nerve is located on the neck. The procedure lasts 5 minutes and is done in the clinic.\n\nInjection of steroid-lidocaine mixture: Superior laryngeal nerve block using 1mg 1:1 triamcinolone 40mg: 1% lidocaine with 1:200000 epinephrine as the injection.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Will receive saline injection as a placebo\n\nSuperior laryngeal nerve block: Injection of either the steroid-lidocaine mixture or placebo through the skin around where the superior laryngeal nerve is located on the neck. The procedure lasts 5 minutes and is done in the clinic.\n\nInjection of placebo (saline): Superior laryngeal nerve block using 1mL of saline as the injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.15', 'spread': '4.52', 'groupId': 'OG000'}, {'value': '9.54', 'spread': '3.87', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Daily for 3 months post-injection', 'description': 'Participants rate cough severity on a 0-15 visual analogue scale. Scores are recorded daily and analyzed using regression. Higher scores indicate greater severity. VAS is a 0-15 scale completed daily by participants.\n\nSeverity is measured using a ruler to determine percentage along the scale. Scores were analyzed using regression models to assess trends over time.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Steroid-Lidocaine Mixture', 'description': 'Will receive numbing injection, which is a mixture of steroid and lidocaine\n\nSuperior laryngeal nerve block: Injection of either the steroid-lidocaine mixture or placebo through the skin around where the superior laryngeal nerve is located on the neck. The procedure lasts 5 minutes and is done in the clinic.\n\nInjection of steroid-lidocaine mixture: Superior laryngeal nerve block using 1mg 1:1 triamcinolone 40mg: 1% lidocaine with 1:200000 epinephrine as the injection.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Will receive saline injection as a placebo\n\nSuperior laryngeal nerve block: Injection of either the steroid-lidocaine mixture or placebo through the skin around where the superior laryngeal nerve is located on the neck. The procedure lasts 5 minutes and is done in the clinic.\n\nInjection of placebo (saline): Superior laryngeal nerve block using 1mL of saline as the injection.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': '10', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects will be recruited within the standard workup for chronic cough in the clinic. Patients will be screened at the initial visit if they meet inclusion criteria or at further visits after additional workup for other sources of cough is completed, patients will be offered participation in the study. The principal investigator will discuss risks and benefits of study participation with the eligible subjects using the informed consent form.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Steroid-Lidocaine Mixture', 'description': 'Will receive numbing injection, which is a mixture of steroid and lidocaine\n\nSuperior laryngeal nerve block: Injection of either the steroid-lidocaine mixture or placebo through the skin around where the superior laryngeal nerve is located on the neck. The procedure lasts 5 minutes and is done in the clinic.\n\nInjection of steroid-lidocaine mixture: Superior laryngeal nerve block using 1mg 1:1 triamcinolone 40mg: 1% lidocaine with 1:200000 epinephrine as the injection.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Will receive saline injection as a placebo\n\nSuperior laryngeal nerve block: Injection of either the steroid-lidocaine mixture or placebo through the skin around where the superior laryngeal nerve is located on the neck. The procedure lasts 5 minutes and is done in the clinic.\n\nInjection of placebo (saline): Superior laryngeal nerve block using 1mL of saline as the injection.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.3', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '65'}, {'value': '56.3', 'groupId': 'BG001', 'lowerLimit': '18', 'upperLimit': '65'}, {'value': '56.3', 'groupId': 'BG002', 'lowerLimit': '18', 'upperLimit': '65'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'LCQ scores, VAS scores'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-12-20', 'size': 463269, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-12-26T21:21', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two treatment arms:\n\n1. Treatment Group (n=25) - 2 mL of 1:1 triamcinolone 40:1% lidocaine with 1:2000000 epinephrine.\n2. Placebo group (n=25) 2 mL of saline.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-25', 'studyFirstSubmitDate': '2020-06-04', 'resultsFirstSubmitDate': '2023-12-26', 'studyFirstSubmitQcDate': '2020-06-04', 'lastUpdatePostDateStruct': {'date': '2025-10-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-09-25', 'studyFirstPostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-10-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Cough Severity', 'timeFrame': 'Change from Baseline to 3 months', 'description': 'Patient will complete the Leicester Cough Questionnaire at each visit. This is a validated survey that measures 3 domains (physical, psychological and social). The total score range is 3-21 and domain scores range from 1-7; a higher score indicates a better quality of life.'}], 'secondaryOutcomes': [{'measure': 'Subjective Improvement in Cough', 'timeFrame': 'Baseline, 1-4 weeks post-injection, and 3 months post-treatment', 'description': "Improvement was defined as a 'yes' response at any time point during the study (1-4 weeks or 3 months post-treatment). The reported value reflects the total number of participants who reported improvement at any time point."}, {'measure': 'Summed Daily Change in Subjective Cough Severity', 'timeFrame': 'Daily for 3 months post-injection', 'description': 'Participants rate cough severity on a 0-15 visual analogue scale. Scores are recorded daily and analyzed using regression. Higher scores indicate greater severity. VAS is a 0-15 scale completed daily by participants.\n\nSeverity is measured using a ruler to determine percentage along the scale. Scores were analyzed using regression models to assess trends over time.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['superior laryngeal nerve block', 'chronic cough'], 'conditions': ['Cough', 'Superior Laryngeal Nerve Block', 'Neurogenic Cough']}, 'descriptionModule': {'briefSummary': 'This is a research study to find out if superior laryngeal nerve blocks are an effective way to reduce cough when compared to placebo (a substance without any medical value). Eligibility for the study include the following: age \\>18, cough history suggestive that the nerve to the voice box is overactive, non-smoker, Patients will be followed over time and assigned to either the treatment or placebo group at random. The treatment would be four superior laryngeal nerve blocks and the placebo would be four saline injections (the inactive substance). Study team will measure if the injection improved cough and ask patients to keep a log of symptoms and fill out questionnaires at each visit. After the four injections, patients will follow up in 3 months to see if cough has returned and if so, how severe the cough is.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* History consistent with neurogenic cough\n* Exclusion of other etiologies (see exclusion criteria)\n* Age ≥ 18\n\nExclusion Criteria:\n\n* Current neuromodulating medication use\n* Untreated other etiologies of cough:\n\nCurrent smoker Current ACE/ARB use Abnormal PFTs within 6 months Uncontrolled OSA Abnormal CXR within 6 months RSI \\> 13 or RFS \\>11 AND workup positive for GERD (esophagram, 24-hour pH probe, manometry, EGD)'}, 'identificationModule': {'nctId': 'NCT04421092', 'briefTitle': 'Efficacy of SLN Block for Chronic Cough', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of South Carolina'}, 'officialTitle': 'Efficacy of Superior Laryngeal Nerve Block for Chronic Cough', 'orgStudyIdInfo': {'id': '00096384'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Steroid-Lidocaine Mixture', 'description': 'Will receive numbing injection, which is a mixture of steroid and lidocaine', 'interventionNames': ['Procedure: Superior laryngeal nerve block', 'Procedure: Injection of steroid-lidocaine mixture']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Will receive saline injection as a placebo', 'interventionNames': ['Procedure: Superior laryngeal nerve block', 'Procedure: Injection of placebo (saline)']}], 'interventions': [{'name': 'Superior laryngeal nerve block', 'type': 'PROCEDURE', 'otherNames': ['Injection of steroid-lidocaine mixture vs. placebo (saline)'], 'description': 'Injection of either the steroid-lidocaine mixture or placebo through the skin around where the superior laryngeal nerve is located on the neck. The procedure lasts 5 minutes and is done in the clinic.', 'armGroupLabels': ['Placebo', 'Steroid-Lidocaine Mixture']}, {'name': 'Injection of placebo (saline)', 'type': 'PROCEDURE', 'otherNames': ['1mL of saline as the injection'], 'description': 'Superior laryngeal nerve block using 1mL of saline as the injection.', 'armGroupLabels': ['Placebo']}, {'name': 'Injection of steroid-lidocaine mixture', 'type': 'PROCEDURE', 'otherNames': ['1mg 1:1 triamcinolone 40mg: 1% lidocaine with 1:200000 epinephrine as the injection.'], 'description': 'Superior laryngeal nerve block using 1mg 1:1 triamcinolone 40mg: 1% lidocaine with 1:200000 epinephrine as the injection.', 'armGroupLabels': ['Steroid-Lidocaine Mixture']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29403', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}], 'overallOfficials': [{'name': 'Courtney Tipton', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of South Carolina'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}