Ignite Creation Date:
2025-12-24 @ 6:46 PM
Ignite Modification Date:
2025-12-30 @ 9:43 AM
Study NCT ID:
NCT01325857
Status:
COMPLETED
Last Update Posted:
2012-02-28
First Post:
2011-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analgesic Efficacy of Bilateral Superficial Cervical Plexus Block in Robot-assisted Endoscopic Thyroidectomy Using a Transaxillary Approach
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013964', 'term': 'Thyroid Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 97}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-26', 'studyFirstSubmitDate': '2011-03-28', 'studyFirstSubmitQcDate': '2011-03-29', 'lastUpdatePostDateStruct': {'date': '2012-02-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual analogue pain score', 'timeFrame': 'Immediate post-operation (at recovery room) (day 1)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Thyroid Cancer']}, 'referencesModule': {'references': [{'pmid': '22956016', 'type': 'DERIVED', 'citation': 'Shin S, Chung WY, Jeong JJ, Kang SW, Oh YJ. Analgesic efficacy of bilateral superficial cervical plexus block in robot-assisted endoscopic thyroidectomy using a transaxillary approach. World J Surg. 2012 Dec;36(12):2831-7. doi: 10.1007/s00268-012-1780-0.'}]}, 'descriptionModule': {'briefSummary': "This study was designed to investigate the analgesic effect of bilateral superficial cervical plexus block in patients undergoing robot-assisted endoscopic thyroidectomy. The investigators hypothesized that bilateral superficial cervical plexus blockade would reduce the patient's pain score by more than 10 (on a VAS scale of 0\\~100) compared to a placebo group and control group."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA class 1 or 2 adult patients scheduled for robot-assisted endoscopic thyroidectomy\n\nExclusion Criteria:\n\n* Patient refusal\n* Bleeding diathesis\n* Allergies to local anesthetics\n* Patient unable to read consent form (Foreigner, illiterate)\n* Pregnant women'}, 'identificationModule': {'nctId': 'NCT01325857', 'briefTitle': 'Analgesic Efficacy of Bilateral Superficial Cervical Plexus Block in Robot-assisted Endoscopic Thyroidectomy Using a Transaxillary Approach', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'Analgesic Efficacy of Bilateral Superficial Cervical Plexus Block in Robot-assisted Endoscopic Thyroidectomy Using a Transaxillary Approach', 'orgStudyIdInfo': {'id': '4-2010-0668'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': 'Group B = Nerve block group', 'interventionNames': ['Procedure: Bilateral superficial cervical plexus block']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group L', 'description': 'Group L = Local wound infiltration group', 'interventionNames': ['Procedure: placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group C', 'description': 'Group C = Control group', 'interventionNames': ['Procedure: Control group']}], 'interventions': [{'name': 'Bilateral superficial cervical plexus block', 'type': 'PROCEDURE', 'description': 'Bilateral superficial cervical plexus block with 0.525% ropivacaine 20ml', 'armGroupLabels': ['Group B']}, {'name': 'placebo', 'type': 'PROCEDURE', 'description': 'Procedure: Bilateral superficial cervical plexus block with normal saline 20ml', 'armGroupLabels': ['Group L']}, {'name': 'Control group', 'type': 'PROCEDURE', 'description': 'Procedure: Local anesthetic infiltration at incision site with 0.525% ropivacaine 20ml', 'armGroupLabels': ['Group C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}