Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2026-02-05 @ 10:46 PM
Study NCT ID:
NCT02066727
Status:
COMPLETED
Last Update Posted:
2014-12-22
First Post:
2014-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Lidocaine Combined Dexmedetomidine for Obturator Nerve Block
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'luyuechun@sina.com', 'phone': '15902233666', 'title': 'Dr Yuechun LU', 'organization': 'Tianjin Medical University General Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Form the completion of obturator nerve block to 24 hours after operation.', 'eventGroups': [{'id': 'EG000', 'title': 'Normal Saline', 'description': 'Normal Saline is administrated as an adjuvant of lidocaine.', 'otherNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Dexmedetomidine', 'description': 'Dexmedetomidine is administrated as an adjuvant of lidocaine at a dose of 1.0 μg/ kg.', 'otherNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Median Effective Concentration(EC50)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Saline', 'description': 'Normal Saline is administrated as an adjuvant of lidocaine.\n\nNormal Saline: Normal Saline is administrated as an adjuvant of lidocaine.'}, {'id': 'OG001', 'title': 'Dexmedetomidine', 'description': 'Dexmedetomidine is administrated as an adjuvant of lidocaine at a dose of 1.0 μg/ kg.\n\nDexmedetomidine: Dexmedetomidine is administrated as an adjuvant of lidocaine at a dose of 1.0 μg/ kg.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.7', 'groupId': 'OG000', 'lowerLimit': '5.4', 'upperLimit': '6.2'}, {'value': '2.9', 'groupId': 'OG001', 'lowerLimit': '2.8', 'upperLimit': '3.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '10min', 'description': 'Median effective concentration(EC50) was not calculated per-participants, the "up-and-down" sequential allocation method was used to determine the median effective concentration(EC50) of lidocaine, running the two groups in parallel. The concentration of lidocaine for the second and subsequent patients in each group were dictated by the response of the previous patient in the group, such that an effective block led to a decreased concentration of the next patient, an ineffective block led to an increased concentration.\n\nFor each group, we collected: the logarithm of lidocaine concentration, the number of effective block, ineffective block, total number of the patient, and successful rate. Then lgEC50 and slgEC50 was calculated as formulas. The logarithm of confidence intervals(95% CI) was calculated as lgEC50±1.96slgEC50. All of the calculation can be performed by SPSS19.0 for windows.', 'unitOfMeasure': 'mg/ml(the concentration of lidocaine)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Complication Related With Nerve Block', 'timeFrame': 'during operation, 0.5,24hour postoperatively', 'description': 'Complication related with nerve block is defined as the presence of either bradycardia, delayed recovery, persistent groin pain, neuropathy during operation and postoperatively', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Normal Saline', 'description': 'Normal Saline is administrated as an adjuvant of lidocaine.'}, {'id': 'FG001', 'title': 'Dexmedetomidine', 'description': 'Dexmedetomidine is administrated as an adjuvant of lidocaine at a dose of 1.0 μg/ kg.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'The patients with the following condition was excluded from the study: ASA III orIV; weight \\<50 or \\>100 kg；BMI\\<19 or \\>30kg/m2；age younger than 18 yr or older than 80yr；preexisting neurologic deficits of the lower extremities, DM; alcohol or drug abuse; abnormal coagulation function'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Normal Saline', 'description': 'Normal Saline is administrated as an adjuvant of lidocaine.'}, {'id': 'BG001', 'title': 'Dexmedetomidine', 'description': 'Dexmedetomidine is administrated as an adjuvant of lidocaine at a dose of 1.0 μg/ kg.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62', 'spread': '14', 'groupId': 'BG000'}, {'value': '68', 'spread': '9', 'groupId': 'BG001'}, {'value': '65', 'spread': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-11', 'studyFirstSubmitDate': '2014-02-17', 'resultsFirstSubmitDate': '2014-11-18', 'studyFirstSubmitQcDate': '2014-02-17', 'lastUpdatePostDateStruct': {'date': '2014-12-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-12-11', 'studyFirstPostDateStruct': {'date': '2014-02-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Median Effective Concentration(EC50)', 'timeFrame': '10min', 'description': 'Median effective concentration(EC50) was not calculated per-participants, the "up-and-down" sequential allocation method was used to determine the median effective concentration(EC50) of lidocaine, running the two groups in parallel. The concentration of lidocaine for the second and subsequent patients in each group were dictated by the response of the previous patient in the group, such that an effective block led to a decreased concentration of the next patient, an ineffective block led to an increased concentration.\n\nFor each group, we collected: the logarithm of lidocaine concentration, the number of effective block, ineffective block, total number of the patient, and successful rate. Then lgEC50 and slgEC50 was calculated as formulas. The logarithm of confidence intervals(95% CI) was calculated as lgEC50±1.96slgEC50. All of the calculation can be performed by SPSS19.0 for windows.'}], 'secondaryOutcomes': [{'measure': 'Complication Related With Nerve Block', 'timeFrame': 'during operation, 0.5,24hour postoperatively', 'description': 'Complication related with nerve block is defined as the presence of either bradycardia, delayed recovery, persistent groin pain, neuropathy during operation and postoperatively'}]}, 'conditionsModule': {'keywords': ['Dexmedetomidine', 'obturator nerve block', 'lidocaine', 'EC50'], 'conditions': ['Nerve Block']}, 'referencesModule': {'references': [{'pmid': '27341450', 'type': 'DERIVED', 'citation': 'Lu Y, Sun J, Zhuang X, Lv G, Li Y, Wang H, Wang G. Perineural Dexmedetomidine as an Adjuvant Reduces the Median Effective Concentration of Lidocaine for Obturator Nerve Blocking: A Double-Blinded Randomized Controlled Trial. PLoS One. 2016 Jun 24;11(6):e0158226. doi: 10.1371/journal.pone.0158226. eCollection 2016.'}]}, 'descriptionModule': {'briefSummary': 'Hypothesis: Dexmedetomidine as an adjuvant of lidocaine can decrease the median effective concentration(EC50) of lidocaine for obturator nerve block during transurethral resection of bladder tumor', 'detailedDescription': 'A selective obturator nerve block(ONB) is an effective alternative to suppress the obturator nerve reflex which is defined as a sudden, violent adductor muscle spasm when the obturator nerve is stimulated directly by the electronic resector during transurethral resection of the tumor on the lateral bladder wall. Studies showed Dexmedetomidine as an adjuvant to local anesthetic prolongs peripheral nerve block duration without any nerve toxicity. In the following randomized, non-crossover study, the investigators test if Dexmedetomidine as an adjuvant can decrease the median effective concentration(EC50) of lidocaine for obturator nerve block during transurethral resection of bladder tumor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subjects scheduled to undergo elective operation of TURBT on lateral wall for whom ONB was needed diagnosed through cystoscopy or CT examination preoperatively.\n2. Subject's American Society of Anesthesiologists physical status is I-II.\n3. The subject's parent/legally authorized guardian has given written informed consent to participate.\n\nExclusion Criteria:\n\n1. Subject has a diagnosis of abnormal coagulation function.\n2. Subject has a diagnosis of Diabetes mellitus.\n3. Subject has a preexisting neurologic deficits of the lower extremities.\n4. Subject has a history of alcohol or drug abuse.\n5. Subject is pregnant or breast-feeding.\n6. Subject is obese (body mass index \\>30kg/m2)."}, 'identificationModule': {'nctId': 'NCT02066727', 'acronym': 'ONB', 'briefTitle': 'Lidocaine Combined Dexmedetomidine for Obturator Nerve Block', 'organization': {'class': 'OTHER', 'fullName': 'Tianjin Medical University General Hospital'}, 'officialTitle': 'Effects of Dexmedetomidine as an Adjuvant on the Median Effective Concentration of Lidocaine for Obturator Nerve Block - A Perspective, Randomized，Blind Study', 'orgStudyIdInfo': {'id': 'GW002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dexmedetomidine', 'description': 'Dexmedetomidine is administrated as an adjuvant of lidocaine at a dose of 1.0 μg/ kg.', 'interventionNames': ['Drug: Dexmedetomidine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Normal Saline', 'description': 'Normal Saline is administrated as an adjuvant of lidocaine.', 'interventionNames': ['Drug: Normal Saline']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'description': 'Dexmedetomidine is administrated as an adjuvant of lidocaine at a dose of 1.0 μg/ kg.', 'armGroupLabels': ['Dexmedetomidine']}, {'name': 'Normal Saline', 'type': 'DRUG', 'description': 'Normal Saline is administrated as an adjuvant of lidocaine.', 'armGroupLabels': ['Normal Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '300000', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'Tainjin Medical University General Hospita& the Second Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'overallOfficials': [{'name': 'Guolin Wang, MD.PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tainjin Medical University General Hospita'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guolin Wang', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tianjin Medical University General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Tianjin Medical University General Hospital', 'investigatorFullName': 'Guolin Wang', 'investigatorAffiliation': 'Tianjin Medical University General Hospital'}}}}