Ignite Creation Date:
2025-12-17 @ 2:47 PM
Ignite Modification Date:
2025-12-23 @ 4:52 PM
Study NCT ID:
NCT02981095
Status:
COMPLETED
Last Update Posted:
2016-12-02
First Post:
2016-11-25
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Bupivacaine Application on Postthyroidectomy Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-22'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013965', 'term': 'Thyroidectomy'}, {'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D013507', 'term': 'Endocrine Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 91}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-01', 'studyFirstSubmitDate': '2016-11-25', 'studyFirstSubmitQcDate': '2016-12-01', 'lastUpdatePostDateStruct': {'date': '2016-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-operative pain in 8 hours after surgery using VAS', 'timeFrame': '8th hour', 'description': 'Evaluation of the pain through the post-operative first 8 hours using VAS'}], 'secondaryOutcomes': [{'measure': 'Post-operative pain in in first post-operative day using VAS', 'timeFrame': '1 day', 'description': 'Evaluation of the pain through the first post-operative day using VAS'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Thyroid Disease', 'Analgesia']}, 'descriptionModule': {'briefSummary': 'Investigators aimed to evaluate the impact of bupivacaine administration into the surgical field after total thyroidectomy on post-operative pain and analgesic requirement with a double-blind, prospective, clinical, randomized study.\n\nPain assessment was performed with the visual analog score (VAS). Participants were pre-operatively, divided into two groups randomly to receive either bupivacaine or not. One group received a 10 ml of bupivacaine solution while the other group was treated with the same volume of 0.9% sodium chloride (NaCl) through the drain after completion of total thyroidectomy procedure. All participants were anesthetized and operated with the same anesthesia and surgical team.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects need to be operated for thyroid diseases\n\nExclusion Criteria:\n\n* History of previous thyroid disease,\n* History of previous neck operations,\n* Hypersensitivity to the drugs that were used in the study protocol,\n* Spinal bone disease,\n* Depression,\n* Kidney failure,\n* Heart failure,\n* Liver failure,\n* Pulmonary failure,\n* Mental retardation,\n* Subjects not able to ascertain pain scoring with the visual analog score (VAS),\n* Patients with American Society of Anesthesiologists (ASA) scores III or higher,\n* Expected airway difficulty according to Mallampati scores,\n* Sedative, steroid, and chronic analgesic drug users,\n* Alcoholics'}, 'identificationModule': {'nctId': 'NCT02981095', 'briefTitle': 'Effect of Bupivacaine Application on Postthyroidectomy Pain', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University'}, 'officialTitle': 'Bupivacaine Application Reduces Postthyroidectomy Pain: Cerrahpaşa Experience', 'orgStudyIdInfo': {'id': 'IUCTF-EndSx-2010-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Bupivacaine', 'description': 'bupivacaine 0.5%, 10cc was administered to surgical field after completion of Thyroidectomy and approximately 15-30 minutes before the extubation.', 'interventionNames': ['Procedure: Thyroidectomy', 'Drug: Bupivacaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline', 'description': 'Saline solution (%0.9 sodium chloride), 10cc was administered to surgical field after completion of Thyroidectomy and approximately 15-30 minutes before the extubation.', 'interventionNames': ['Procedure: Thyroidectomy', 'Drug: Saline Solution']}], 'interventions': [{'name': 'Thyroidectomy', 'type': 'PROCEDURE', 'description': 'Thyroidectomy performed by the same surgical and anesthesia team', 'armGroupLabels': ['Bupivacaine', 'Saline']}, {'name': 'Bupivacaine', 'type': 'DRUG', 'description': 'bupivacaine 0.5%, 10cc was administered to surgical field after completion of Thyroidectomy and approximately 15-30 minutes before the extubation.', 'armGroupLabels': ['Bupivacaine']}, {'name': 'Saline Solution', 'type': 'DRUG', 'description': '%0.9 sodium chloride solution, 10cc was administered to surgical field after completion of Thyroidectomy and approximately 15-30 minutes before the extubation.', 'armGroupLabels': ['Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34098', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul University, Cerrahpasa Medical Faculty', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Yusuf BUKEY, Prof. MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Istanbul University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Serkan TEKSOZ', 'investigatorAffiliation': 'Istanbul University'}}}}