Ignite Creation Date:
2025-12-24 @ 3:38 PM
Ignite Modification Date:
2025-12-26 @ 10:35 PM
Study NCT ID:
NCT07230392
Status:
COMPLETED
Last Update Posted:
2025-11-17
First Post:
2025-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Superficial Cervical Plexus Block Versus Ketamine in the Prevention of Chronic Pain After Thyroidectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-10-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-07-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-13', 'studyFirstSubmitDate': '2025-11-13', 'studyFirstSubmitQcDate': '2025-11-13', 'lastUpdatePostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-04-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of chronic neuropathic pain at three months', 'timeFrame': 'three months after thyroidectomy', 'description': 'The incidence of chronic neuropathic pain at three months after thyroidectomy, as determined by the DN4 questionnaire.'}], 'secondaryOutcomes': [{'measure': 'Twenty-four hour postoperative rescue analgesia requirements', 'timeFrame': 'within the first 24 hours after the thyroidectomy.', 'description': 'The total amount of extra, on-demand pain medication a patient needed in the first 24 hours after their surgery was completed.'}, {'measure': 'Intraoperative sufentanil consumption', 'timeFrame': 'During the intraoperative period', 'description': 'The secondary endpoints included intraoperative sufentanil consumption and reinjection requirements.'}, {'measure': 'Postoperative sleep quality', 'timeFrame': 'During the first 24 postoperative hours.', 'description': 'Sleep quality was assessed 24 hours postoperatively to accurately reflect the effects of analgesia, utilizing the Athens Insomnia Scale (AIS) score.'}, {'measure': 'Incidence of postoperative nausea and vomiting (PONV) within 24 hours post-surgery', 'timeFrame': '24 hours after surgery.', 'description': 'Occurrence of at least one episode of nausea or vomiting within the first 24 hours after surgery.'}, {'measure': "The Observer's Assessment of Alertness/Sedation (OAA/S) within a 2-hour timeframe following thyroidectomy.", 'timeFrame': '2-hour timeframe following thyroidectomy', 'description': "Patients underwent Observer's Assessment of Alertness/Sedation (OAA/S) assessment within a 2-hour timeframe following thyroidectomy, before being cleared for PACU discharge."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ketamine', 'Thyroidectomy', 'Cervical block'], 'conditions': ['Chronic Pain', 'Thyroidectomy']}, 'descriptionModule': {'briefSummary': 'The goal of our work is to to compare the effect of preemptive Ketamine administration versus superficial cervical plexus block on the incidence of postoperative neuropathic pain in patients undergoing thyroidectomy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18 to 80 years\n* Scheduled for thyroidectomy under general anesthesia.\n* American Society of Anesthesiologists (ASA) physical status I-III.\n* Able to understand the study procedures and provide written informed consent\n\nExclusion Criteria:\n\n* Known allergy to ketamine or local anesthetics\n* Severe renal impairment with estimated Glomerular Filtration Rate (eGFR) under 30 mL/min\n* History of neurological disorders\n* History of psychiatric illness\n* History of severe cardiac disease (NYHA III-IV) or serious arrhythmias\n* Pregnancy or breastfeeding\n* Morbid obesity (BMI \\> 40 kg/m²)\n* Cognitive or communication impairment\n* Refusal to participate'}, 'identificationModule': {'nctId': 'NCT07230392', 'acronym': 'Thyrobloket', 'briefTitle': 'Superficial Cervical Plexus Block Versus Ketamine in the Prevention of Chronic Pain After Thyroidectomy', 'organization': {'class': 'OTHER', 'fullName': 'University Tunis El Manar'}, 'officialTitle': 'Comparison of Superficial Cervical Plexus Block and Ketamine in the Prevention of Chronic Pain After Thyroidectomy: Results of a Prospective Randomized Study', 'orgStudyIdInfo': {'id': 'Thyrobloket'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'BCS Group', 'description': 'Patients received a bilateral ultrasound-guided superficial cervical plexus block after induction (Ropivacaine 0.2%,with a volume of 10 mL administered to each side)', 'interventionNames': ['Procedure: Superficial cervical plexus block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'KETA group', 'description': 'Patients received intravenous ketamine (0.25 mg/kg bolus followed by a 2 µg/kg/min infusion).', 'interventionNames': ['Drug: Ketamine perfusion']}], 'interventions': [{'name': 'Ketamine perfusion', 'type': 'DRUG', 'description': 'Intravenous ketamine 0.25 mg/kg bolus followed by a 2 µg/kg/min infusion', 'armGroupLabels': ['KETA group']}, {'name': 'Superficial cervical plexus block', 'type': 'PROCEDURE', 'description': 'Bilateral ultrasound-guided superficial cervical plexus block after induction(Ropivacaine 0.2% Ropivacaine 0.2%, with a volume of 10 mL administered to each side) was performed for patients of this group', 'armGroupLabels': ['BCS Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Nabeul', 'state': 'Nabeul Governorate', 'country': 'Tunisia', 'facility': 'Mohamed Taher Maamouri University Hospital', 'geoPoint': {'lat': 36.45606, 'lon': 10.73763}}], 'overallOfficials': [{'name': 'ibtissem BEN TALEB', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Tunis El Manar, Anesthesia and critical care department, Taher Maamouri University Hospital,'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Tunis El Manar', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor in Anesthesiology and Intensive Care', 'investigatorFullName': 'Ben Taleb Ibtissem', 'investigatorAffiliation': 'University Tunis El Manar'}}}}