Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-03-06 @ 6:02 PM
Study NCT ID:
NCT02108834
Status:
UNKNOWN
Last Update Posted:
2015-01-21
First Post:
2014-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Regional Anesthesia for Thyroidectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D059787', 'term': 'Acute Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009407', 'term': 'Nerve Block'}], 'ancestors': [{'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D003714', 'term': 'Denervation'}, {'id': 'D019635', 'term': 'Neurosurgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 79}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2015-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-01-19', 'studyFirstSubmitDate': '2014-04-04', 'studyFirstSubmitQcDate': '2014-04-06', 'lastUpdatePostDateStruct': {'date': '2015-01-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The over-all satisfaction of patients', 'timeFrame': '24 hours', 'description': 'The over-all satisfaction of patients after the surgery'}], 'primaryOutcomes': [{'measure': 'the incidence of chronic postsurgery pain', 'timeFrame': '60 days', 'description': 'the time from the end of surgery'}], 'secondaryOutcomes': [{'measure': 'the intensity of acute pain', 'timeFrame': '24 hours', 'description': 'swallowing pain and rest pain'}, {'measure': 'hemodynamic stability', 'timeFrame': '1 day', 'description': 'blood pressure and heart rate intraoperative responses.'}, {'measure': 'postoperative nausea and vomiting', 'timeFrame': '2 days after operation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['chronic postsurgery pain', 'acute pain'], 'conditions': ['Chronic Pain', 'Acute Pain']}, 'referencesModule': {'references': [{'pmid': '16698416', 'type': 'BACKGROUND', 'citation': 'Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. doi: 10.1016/S0140-6736(06)68700-X.'}, {'pmid': '11375842', 'type': 'BACKGROUND', 'citation': 'Dieudonne N, Gomola A, Bonnichon P, Ozier YM. Prevention of postoperative pain after thyroid surgery: a double-blind randomized study of bilateral superficial cervical plexus blocks. Anesth Analg. 2001 Jun;92(6):1538-42. doi: 10.1097/00000539-200106000-00038.'}, {'pmid': '18931238', 'type': 'RESULT', 'citation': 'Brogly N, Wattier JM, Andrieu G, Peres D, Robin E, Kipnis E, Arnalsteen L, Thielemans B, Carnaille B, Pattou F, Vallet B, Lebuffe G. Gabapentin attenuates late but not early postoperative pain after thyroidectomy with superficial cervical plexus block. Anesth Analg. 2008 Nov;107(5):1720-5. doi: 10.1213/ane.0b013e318185cf73.'}]}, 'descriptionModule': {'briefSummary': 'For more than 25 years, Regional Anesthesia has challenged anesthesiologists to determine whether it offers real benefits in terms of patient outcome from major surgery, compared with general anesthesia. Although it is clear that regional analgesia in association with general anesthesia substantially reduces postoperative pain, the benefits in terms of overall perioperative outcome are controversial. The aim of this study is to evaluate the effect on short and long-term postoperative outcomes of adding regional analgesia to general anaesthesia in thoridetomic patients.', 'detailedDescription': 'Patients who are divided into two treatment groups: (a) a bilateral superficial cervical plexus group (group S) and a control group (group C).We performe bilateral superficial cervical plexus block (BSCPB)with 0.25-0.75% ropivacaine10 ml to group S and 10ml NaCl 0.9% to group C. All BSCPB is performed by experienced anesthesia doctor after a standardized induction of general anaesthesia.eneral anaesthesia was induced by using intravenously with midazolam,propofol, fentanyl, cisatracurium is injected IV to facilitate orotracheal intubation. After a standardized induction of general anaesthesia, patients receive Regional Anesthesia at the discretion of the experienced anesthesiologist who was blinded to treatment.\n\nThe patient is placed in a supine position with the head turned away from the side to be blocked, and then the sternocleidomastoid muscle (SCM) is identified by slight head elevation. SCPB is performed with a 26-gauge needle that is inserted at the midpoint of the posterior border of the SCM muscle and the needle is advanced just past the SCM muscle.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-Eligible patients fit an ASA I or II classification adult patients who will be scheduled for elective thyroid lobectomy under general anaesthesia.\n\nExclusion Criteria:\n\n* hypersensitivity to any study drugs\n* Long-term use of anticoagulant drugs: warfarin or heparin\n* the neck or systemic infection\n* communication disorder\n* refuse to accept this research subjects.'}, 'identificationModule': {'nctId': 'NCT02108834', 'briefTitle': 'Regional Anesthesia for Thyroidectomy', 'organization': {'class': 'OTHER', 'fullName': "Guangzhou First People's Hospital"}, 'officialTitle': 'Randomized Controlled Trial of Regional Anesthesia in Combination With General Anesthesia for Thyroidectomy', 'orgStudyIdInfo': {'id': 'GZFPH-IRB-2013-085'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'nerve block', 'description': 'cervical plexus block with ropivacaine', 'interventionNames': ['Procedure: nerve block']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'placebo saline', 'interventionNames': ['Procedure: placebo']}], 'interventions': [{'name': 'nerve block', 'type': 'PROCEDURE', 'description': 'After general anaesthesia,the patient is placed in a supine position with the head turn away from the side to be blocked, and then the sternocleidomastoid muscle (SCM) is identified by slight head elevation. SCPB(superficial cervical plexus block) is performed with a 26-gauge needle that is inserted at the midpoint of the posterior border of the SCM muscle and the needle is advanced just past the SCM muscle. The mixture is prepared with 20ml of 0.5% ropivacaine in Group 1', 'armGroupLabels': ['nerve block']}, {'name': 'placebo', 'type': 'PROCEDURE', 'description': 'After general anaesthesia,the patient is placed in a supine position with the head turn away from the side to be blocked, and then the sternocleidomastoid muscle (SCM) is identified by slight head elevation. SCPB(superficial cervical plexus block) is performed with a 26-gauge needle that is inserted at the midpoint of the posterior border of the SCM muscle and the needle is advanced just past the SCM muscle. The mixture is prepared with 20ml of 0.9% saline in Group 2.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510180', 'city': 'Guangzhou', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': "Guangzhou First Municipal People's Hospital", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiangcai Ruan', 'role': 'CONTACT', 'email': 'xc_ruan@hotmail.com', 'phone': '8620-81048306'}, {'name': 'Yuan Lin', 'role': 'CONTACT', 'email': 'linyuan1117@163.com', 'phone': '8620-81048310'}, {'name': 'Xiangcai Ruan', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Yuan Lin', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Chengxiang Lu', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Lixin Xu', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Shouzhang She', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Guangzhou First Municipal People's Hospital", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Xiangcai Ruan, MD,PHD', 'role': 'CONTACT', 'email': 'xc_ruan@hotmail.com', 'phone': '+8620-81048306'}, {'name': 'Yuan Lin, MD, Msc', 'role': 'CONTACT', 'email': 'linyuan1117@163.com', 'phone': '+8620-81048306'}], 'overallOfficials': [{'name': 'Xiangcai Ruan, MD, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Guangzhou First Municipal People's Hospital,Guangzhou,Guangdong,China,510180"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guangzhou First People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice chair', 'investigatorFullName': 'Xiangcai Ruan', 'investigatorAffiliation': "Guangzhou First People's Hospital"}}}}