Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-02-20 @ 10:17 AM
Study NCT ID:
NCT03648034
Status:
COMPLETED
Last Update Posted:
2020-04-06
First Post:
2018-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Scalp Nerve Block With Ropivacaine on Postoperative Recovery Quality
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008579', 'term': 'Meningioma'}], 'ancestors': [{'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009383', 'term': 'Neoplasms, Vascular Tissue'}, {'id': 'D008577', 'term': 'Meningeal Neoplasms'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077212', 'term': 'Ropivacaine'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 144}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2019-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-03', 'studyFirstSubmitDate': '2018-08-13', 'studyFirstSubmitQcDate': '2018-08-23', 'lastUpdatePostDateStruct': {'date': '2020-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'KPS score', 'timeFrame': '7 days post-surgery', 'description': 'Karnofsky performance score (KPS) allows patients to be classified as to their functional impairment. The total scale range is 0-100. The lower the KPS score, the worse the survival for most serious illnesses.'}], 'secondaryOutcomes': [{'measure': 'KPS score', 'timeFrame': '3 days post-surgery', 'description': 'Karnofsky performance score (KPS) allows patients to be classified as to their functional impairment. The total scale range is 0-100. The lower the KPS score, the worse the survival for most serious illnesses.'}, {'measure': 'serum TNF-α levels', 'timeFrame': 'at 1h and 24h post-surgery', 'description': 'an inflammatory mediator that reflects systemic inflammation'}, {'measure': 'serum IL-6 levels', 'timeFrame': 'at 1h and 24h post-surgery', 'description': 'an inflammatory mediator that reflects systemic inflammation'}, {'measure': 'serum IL-1β levels', 'timeFrame': 'at 1h and 24h post-surgery', 'description': 'an inflammatory mediator that reflects systemic inflammation'}, {'measure': 'Iowa Satisfaction with Anesthesia Scale (ISAS)', 'timeFrame': '1 hour after the surgery is finished', 'description': 'Iowa Satisfaction with Anesthesia Scale (ISAS) comprises of 11 items to measure patient satisfaction after surgery. The total scale range is -33-+33. The higher the ISAS score, the better the satisfaction level.'}, {'measure': 'white blood cell', 'timeFrame': 'at 24 h after surgery', 'description': 'serum white blood cell count'}, {'measure': 'serum levels of CRP', 'timeFrame': 'at 24 h after surgery', 'description': 'inflammatory responses'}, {'measure': 'VAS score', 'timeFrame': 'at 1, 2 and 3 days post-surgery', 'description': 'The visual analogue scale or visual analog scale (VAS) measures the average intensity of pain in the past on a 0-to-10 scale, where 0 = No pain and 10 = Pain as intense as you can imagine.'}, {'measure': 'pain-relief medications', 'timeFrame': 'at 1, 2 and 3 days post-surgery', 'description': 'amounts of pain-relief medications'}, {'measure': 'Hospitalization Days', 'timeFrame': 'up to 30 days', 'description': 'length of hospitalization'}, {'measure': 'out of pocket expenditure for hospitalisation', 'timeFrame': 'hospital discharge/up to 30 days', 'description': 'This reflects how much money the patient spends during hospitalisation'}, {'measure': 'complications', 'timeFrame': 'within 30 days after surgery', 'description': 'incidence of intracranial infection'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Meningioma']}, 'descriptionModule': {'briefSummary': "Patients undergoing elective meningeoma resection surgery will be randomly assigned to one of the following two groups. After anesthesia induction but before skull-pin insertion, one group will receive scalp nerve blocks with 0.5% ropivacaine, whereas the other group will receive scalp nerve blocks with 0.9% saline. The patients' postoperative recovery quality, which is evaluated by KPS score, peri-operative inflammatory responses, and post-operative pain degree will be evaluated and compared between the two groups.", 'detailedDescription': "Patients undergoing elective meningeoma resection surgery will be randomly assigned to one of the following two groups. After anesthesia induction but before skull-pin insertion, one group will receive scalp nerve blocks with 0.5% ropivacaine, whereas the other group will receive scalp nerve blocks with 0.9% saline. The patients' KPS scores at 3d after surgery and at discharge, serum levels of TNF-α、IL-6，IL-1β at 24h after surgery, satisfaction score after recovery, and VAS scores at 1, 2, 3 days post-surgery will be evaluated and compared between the two groups."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 18-75 years old;\n2. BMI 18-28 kg/m2;\n3. ASA Physical Status 1-2;\n4. Clinical diagnosis of primary Meningeoma and will have elective Meningeoma Resection Surgery;\n5. With an estimated surgery time of less than 4h;\n6. The incision will be conducted at the frontal, top or the temperal skull.\n\nExclusion Criteria:\n\n1. A history of previous brain surgery;\n2. Severe systemic disease (heart, lung, kidney, or immune system);\n3. Nerval or mental disorders;\n4. A history of addiction to opioids;\n5. Allergic to ropivacaine;\n6. Infection at block site or severe systemic infection;\n7. Refuse to attend the trial.'}, 'identificationModule': {'nctId': 'NCT03648034', 'briefTitle': 'Effects of Scalp Nerve Block With Ropivacaine on Postoperative Recovery Quality', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'Effects of Preoperative Scalp Nerve Block on Postoperative Recovery Quality in Patients Undergoing Excision of Intracranial Meningioma', 'orgStudyIdInfo': {'id': 'SNB20180813'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ropivacaine', 'description': 'After anesthesia induction but before skull-pin insertion, patients in this group will receive scalp nerve blocks with 0.5% ropivacaine', 'interventionNames': ['Procedure: ropivacaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'saline', 'description': 'After anesthesia induction but before skull-pin insertion, patients in this group will receive scalp nerve blocks with 0.9% saline', 'interventionNames': ['Procedure: saline']}], 'interventions': [{'name': 'ropivacaine', 'type': 'PROCEDURE', 'description': 'To perform scalp nerve blocks with ropivacaine', 'armGroupLabels': ['ropivacaine']}, {'name': 'saline', 'type': 'PROCEDURE', 'description': 'To perform scalp nerve blocks with saline', 'armGroupLabels': ['saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200127', 'city': 'Shanghai', 'country': 'China', 'facility': 'Renji Hospital affliated to Shanghai Jiaotong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RenJi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jie Tian', 'investigatorAffiliation': 'RenJi Hospital'}}}}