Ignite Creation Date:
2025-12-25 @ 1:04 AM
Ignite Modification Date:
2025-12-25 @ 11:17 PM
Study NCT ID:
NCT05294393
Status:
COMPLETED
Last Update Posted:
2024-07-17
First Post:
2022-03-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ropivacaine Plus Magnesium Sulphate Infiltration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D010279', 'term': 'Parathyroid Diseases'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077212', 'term': 'Ropivacaine'}, {'id': 'D008278', 'term': 'Magnesium Sulfate'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D017616', 'term': 'Magnesium Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D013431', 'term': 'Sulfates'}, {'id': 'D013464', 'term': 'Sulfuric Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-01-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-16', 'studyFirstSubmitDate': '2022-03-01', 'studyFirstSubmitQcDate': '2022-03-23', 'lastUpdatePostDateStruct': {'date': '2024-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of Ropivacaine Plus Magnesium Sulphate Infiltration vs Ropivacaine', 'timeFrame': '24 postoperative hours', 'description': 'Calculation of the total post-operative analgesic doses administered, converted to effective mg of morphine.'}], 'secondaryOutcomes': [{'measure': 'Incisional Pain', 'timeFrame': '30 minutes ,1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours', 'description': 'Incisional Pain will be measured by Visual Analogue Scale (VAS) pain questionnaire'}, {'measure': 'Subjective measurements 1', 'timeFrame': '30 minutes before the infiltration, 6 hours and 24 hours postoperatively', 'description': 'Alterations in cortisol in μg/dl'}, {'measure': 'Subjective measurements 2', 'timeFrame': '30 minutes before the infiltration, 6 hours and 24 hours postoperatively', 'description': 'Alterations in Tumor Necrosis Factor a (TNF-a) in pg/ml'}, {'measure': 'Subjective measurements 3', 'timeFrame': '30 minutes before the infiltration, 6 hours and 24 hours postoperatively', 'description': 'Alterations in Interleukin 6 (IL-6) in pg/ml'}, {'measure': 'Complications', 'timeFrame': '24 hours, 7 days', 'description': 'Adverse effects of the infiltrated agents'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['thyroidectomy', 'parathyroidectomy', 'local wound infiltration', 'ropivacaine', 'magnesium sulphate'], 'conditions': ['Thyroid Diseases', 'Parathyroid Diseases', 'Postoperative Pain', 'Anesthesia, Local']}, 'descriptionModule': {'briefSummary': "In the domain of endocrine gland surgery, thyroidectomy is the most common procedure. Patients report moderate to severe discomfort postoperatively, which is induced by a variety of mechanisms, the most common of which are cervical incision and surgical maneuvers. The other two causes are endotracheal intubation and neck overextension. Incisional pain, odynophagia, dysphagia, neck and shoulder pain have all been reported as sources of discomfort.However, it seems that this discomfort has a time limit, with a considerable decrease in pain scores that will last 24 to 36 hours. Pain is felt more profoundly within the first few hours after surgery, peaking at 6 hours, with patients requesting further analgesic medication.\n\nSurgical wound infiltration can inhibit this procedure by preventing the alginate signal from reaching the incision site's receptors. According to the multimodal analgesia trends, magnesium sulfate can be added to the ropivacaine solution. Magnesium acts as an NMDA (N-methyl-D-aspartate) receptor antagonist, inhibiting cerebral sensitization to peripheral pain stimuli while reducing pre-existing hyperalgesia.\n\nIt becomes evident that this combination could contribute to attain the maximum analgesic efficacy. So, if any superiority of ropivacaine plus magnesium sulphate over ropivacaine could be demonstrated this would be very helpful in providing sufficient analgesic effects with a low incidence of adverse effects, while enhancing the option of one day surgery."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient ≥ 18 years old\n* Surgical indication for Total thyroidectomy\n* Surgical indication forparathyroidectomy\n\nExclusion Criteria:\n\n* Patients \\< 18 years old\n* Prior neck operation\n* Lateral neck dissection\n* Patient with history of chronic opioid use\n* Patient with chronic pain syndromes\n* Patient with allergy to ropivacaine'}, 'identificationModule': {'nctId': 'NCT05294393', 'briefTitle': 'Ropivacaine Plus Magnesium Sulphate Infiltration', 'organization': {'class': 'OTHER', 'fullName': 'Aristotle University Of Thessaloniki'}, 'officialTitle': 'Evaluation of Ropivacaine and Ropivacaine Plus Magnesium Sulphate Infiltration for Postoperative Analgesia in Patients Undergoing Thyroidectomy', 'orgStudyIdInfo': {'id': '3.468'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'N/S 0.9%', 'description': 'Wound infiltration with 12 ml of N/S 0.9% at the end of surgery before wound closure', 'interventionNames': ['Drug: Placebo Comparator: N/S 0.9%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ropivacaine 10%', 'description': 'Wound infiltration with 12 ml solution of 100mg ropivacaine at the end of surgery before wound closure', 'interventionNames': ['Drug: Ropivacaine 10%']}, {'type': 'EXPERIMENTAL', 'label': 'Ropivacaine 10% magnesium sulphate 10mg/kg', 'description': 'Wound infiltration with 12 ml solution of 100mg ropivacaine plus magnesium sulphate 10mg/kg at the end of surgery before wound closure', 'interventionNames': ['Drug: Ropivacaine 10% plus magnesium sulphate 10mg/kg']}], 'interventions': [{'name': 'Placebo Comparator: N/S 0.9%', 'type': 'DRUG', 'description': '12 ml N/S 0.9% at the end of surgery', 'armGroupLabels': ['N/S 0.9%']}, {'name': 'Ropivacaine 10%', 'type': 'DRUG', 'description': '12 ml solution of 100mg ropivacaine at the end of surgery', 'armGroupLabels': ['Ropivacaine 10%']}, {'name': 'Ropivacaine 10% plus magnesium sulphate 10mg/kg', 'type': 'DRUG', 'description': '12 ml solution of 100mg ropivacaine plus magnesium sulphate 10mg/kg at the end of surgery', 'armGroupLabels': ['Ropivacaine 10% magnesium sulphate 10mg/kg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54636', 'city': 'Thessaloniki', 'state': 'Other', 'country': 'Greece', 'facility': 'Aristotle University', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}], 'overallOfficials': [{'name': 'Styliani K Laskou', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aristotle University Of Thessaloniki'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aristotle University Of Thessaloniki', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Styliani Konstantinos Laskou', 'investigatorAffiliation': 'Aristotle University Of Thessaloniki'}}}}