Ignite Creation Date:
2025-12-24 @ 4:09 PM
Ignite Modification Date:
2026-01-09 @ 11:56 AM
Study NCT ID:
NCT02043366
Status:
COMPLETED
Last Update Posted:
2016-01-08
First Post:
2014-01-15
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Butorphanol Combined With Flurbiprofen Axetil on Preventing Hyperalgesia Induced by Remifentanil in Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077330', 'term': 'Saline Solution'}, {'id': 'D002077', 'term': 'Butorphanol'}, {'id': 'C504422', 'term': 'flurbiprofen axetil'}, {'id': 'D000077208', 'term': 'Remifentanil'}, {'id': 'D017409', 'term': 'Sufentanil'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D011422', 'term': 'Propionates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D005283', 'term': 'Fentanyl'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'wangguolinghad@hotmail.com', 'phone': '+8615822855556', 'title': 'Dr. Guolin Wang', 'organization': 'Tianjin Medical University General Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Incidence of adverse effects was evaluated during 24h after surgery', 'eventGroups': [{'id': 'EG000', 'title': 'Normal Saline', 'description': 'Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil\n\nNormal Saline', 'otherNumAtRisk': 28, 'otherNumAffected': 0, 'seriousNumAtRisk': 28, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Flurbiprofen AxetilⅠ', 'description': 'Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before anesthesia induction and intraoperative pain management was with remifentanil\n\nFlurbiprofen axetil: Flurbiprofen axetil is intravenously administrated', 'otherNumAtRisk': 28, 'otherNumAffected': 0, 'seriousNumAtRisk': 28, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Flurbiprofen AxetilⅡ', 'description': 'Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before the skin closure and intraoperative pain management was with remifentanil\n\nFlurbiprofen axetil: Flurbiprofen axetil is intravenously administrated', 'otherNumAtRisk': 28, 'otherNumAffected': 0, 'seriousNumAtRisk': 28, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Butorphanol', 'description': 'Butorphanol is intravenously administrated at a dose of 20μg/ kg before anesthesia induction and intraoperative pain management was with remifentani', 'otherNumAtRisk': 28, 'otherNumAffected': 0, 'seriousNumAtRisk': 28, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Butorphanol-Flurbiprofen Axetil', 'description': 'A dose of 10μg/ kg butorphanol and a dose of 0.5mg/ kg flurbiprofen axetil are intravenously administrated before anesthesia induction and intraoperative pain management was with remifentani', 'otherNumAtRisk': 28, 'otherNumAffected': 0, 'seriousNumAtRisk': 28, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Sufentanil', 'description': 'Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with sufentanil', 'otherNumAtRisk': 28, 'otherNumAffected': 0, 'seriousNumAtRisk': 28, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mechanical Hyperalgesia Threshold on the Dominant Inner Forearm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '28', 'groupId': 'OG004'}, {'value': '28', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Saline', 'description': 'Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil\n\nNormal Saline'}, {'id': 'OG001', 'title': 'Flurbiprofen AxetilⅠ', 'description': 'Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before anesthesia induction and intraoperative pain management was with remifentanil\n\nFlurbiprofen axetil: Flurbiprofen axetil is intravenously administrated'}, {'id': 'OG002', 'title': 'Flurbiprofen AxetilⅡ', 'description': 'Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before the skin closure and intraoperative pain management was with remifentanil\n\nFlurbiprofen axetil: Flurbiprofen axetil is intravenously administrated'}, {'id': 'OG003', 'title': 'Butorphanol', 'description': 'Butorphanol is intravenously administrated at a dose of 20μg/ kg before anesthesia induction and intraoperative pain management was with remifentanil.'}, {'id': 'OG004', 'title': 'Butorphanol-Flurbiprofen Axetil', 'description': 'A dose of 10μg/ kg butorphanol and a dose of 0.5mg/ kg flurbiprofen axetil are intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil.'}, {'id': 'OG005', 'title': 'Sufentanil', 'description': 'Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with sufentanil'}], 'classes': [{'categories': [{'measurements': [{'value': '60.57', 'spread': '22.55', 'groupId': 'OG000'}, {'value': '78.29', 'spread': '24.76', 'groupId': 'OG001'}, {'value': '68.50', 'spread': '21.98', 'groupId': 'OG002'}, {'value': '79.7', 'spread': '20.93', 'groupId': 'OG003'}, {'value': '81.64', 'spread': '20.40', 'groupId': 'OG004'}, {'value': '89.5', 'spread': '23.4', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours after surgery', 'description': 'The mechanical hyperalgesia threshold was defined as the lowest force (g) necessary to bend a Von Frey filament, which was perceived to be painful by the patient and measured by Von Frey filament at 24 hours postoperatively', 'unitOfMeasure': 'g', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Score (NRS)', 'timeFrame': '3h, 6h, 12h, and 24h after surgery', 'description': 'The pain score at rest was evaluated by pain 11-point numerical rating scale (NRS): 0 = no pain, 10 = greatest imaginable pain.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Time of First Postoperative Analgesic Requirement', 'timeFrame': '1 hour post surgery', 'description': 'First postoperative pain (NRS≥5) is initially controlled by titration of sufentanyl.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Occurrence of Side Effects', 'timeFrame': '24 hours', 'description': 'Occurrence of side effects: nausea, vomiting, dizziness, headache, shivering, pruritus', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Total Dose of First Postoperative Analgesic Requirement', 'timeFrame': '1 hour after surgery', 'description': 'First postoperative pain (NRS≥5) is initially controlled by titration of sufentanyl.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Cumulative Sufentanyl Consumption', 'timeFrame': '24 hours', 'description': 'Each patient was administered analgesics using a PCA pump containing sufentanil (100μg) in normal saline at a total volume of 100 ml after leaving PACU. This device was set to deliver a basal infusion of 2 ml/h and bolus doses of 0.5 ml with a 15-min lockout period. Sufentanyl cumulative consumption is recorded 24 hours postoperatively', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Normalized Area of Hyperalgesia Around the Incision', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '28', 'groupId': 'OG004'}, {'value': '28', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Saline', 'description': 'Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil\n\nNormal Saline'}, {'id': 'OG001', 'title': 'Flurbiprofen AxetilⅠ', 'description': 'Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before anesthesia induction and intraoperative pain management was with remifentanil\n\nFlurbiprofen axetil: Flurbiprofen axetil is intravenously administrated'}, {'id': 'OG002', 'title': 'Flurbiprofen AxetilⅡ', 'description': 'Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before the skin closure and intraoperative pain management was with remifentanil\n\nFlurbiprofen axetil: Flurbiprofen axetil is intravenously administrated'}, {'id': 'OG003', 'title': 'Butorphanol', 'description': 'Butorphanol is intravenously administrated at a dose of 20μg/ kg before anesthesia induction and intraoperative pain management was with remifentanil'}, {'id': 'OG004', 'title': 'Butorphanol-Flurbiprofen Axetil', 'description': 'A dose of 10μg/ kg butorphanol and a dose of 0.5mg/ kg flurbiprofen axetil are intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil'}, {'id': 'OG005', 'title': 'Sufentanil', 'description': 'Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with sufentanil'}], 'classes': [{'categories': [{'measurements': [{'value': '60.46', 'spread': '9.98', 'groupId': 'OG000'}, {'value': '53.64', 'spread': '8.63', 'groupId': 'OG001'}, {'value': '56.57', 'spread': '8.98', 'groupId': 'OG002'}, {'value': '54.00', 'spread': '9.30', 'groupId': 'OG003'}, {'value': '52.5', 'spread': '9.15', 'groupId': 'OG004'}, {'value': '49.89', 'spread': '8.57', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours after surgery', 'description': "The skin around the incision is stimulated in steps of 5 mm at intervals of 1 s starting outside of the hyperalgesic area in the direction of the incision. The distance from the incision to the first point where a 'painful', 'sore' or 'sharper' feeling occurred is measured and noted. This measurement is repeated at predefined radial lines around the incision. To eliminate the variable length of incision, this length is subtracted from the longer diameter leaving four radial distances from the end and from the middle of the incision. The normalized area of hyperalgesia is calculated by summing up the areas of the remaining four triangles measured by and Von Frey filament.", 'unitOfMeasure': 'cm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Normal Saline', 'description': 'Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil\n\nNormal Saline'}, {'id': 'FG001', 'title': 'Flurbiprofen AxetilⅠ', 'description': 'Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before anesthesia induction and intraoperative pain management was with remifentanil\n\nFlurbiprofen axetil: Flurbiprofen axetil is intravenously administrated'}, {'id': 'FG002', 'title': 'Flurbiprofen AxetilⅡ', 'description': 'Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before the skin closure and intraoperative pain management was with remifentanil\n\nFlurbiprofen axetil: Flurbiprofen axetil is intravenously administrated'}, {'id': 'FG003', 'title': 'Butorphanol', 'description': 'Butorphanol is intravenously administrated at a dose of 20μg/ kg before anesthesia induction and intraoperative pain management was with remifentanil.'}, {'id': 'FG004', 'title': 'Butorphanol-Flurbiprofen Axetil', 'description': 'A dose of 10μg/kg butorphanol and a dose of 0.5mg/kg flurbiprofen axetil are intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil.'}, {'id': 'FG005', 'title': 'Sufentanil', 'description': 'Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with sufentanil.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '30'}, {'groupId': 'FG003', 'numSubjects': '30'}, {'groupId': 'FG004', 'numSubjects': '30'}, {'groupId': 'FG005', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '28'}, {'groupId': 'FG003', 'numSubjects': '28'}, {'groupId': 'FG004', 'numSubjects': '28'}, {'groupId': 'FG005', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'From February 2014 to June 2015, patients were recruited and estimated for eligibility', 'preAssignmentDetails': 'Exclusion criteria: coronary heart disease, bronchial asthma, cardiac, lung, hepatic and renal insufficiency, severe hypertension, diabetes mellitus, psychiatric disease, obesity, a history of chronic pain, a history of alcohol or opioid abuse, pregnancy, allergy and contraindication to study drugs, a history of gastrointestinal disease'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}, {'value': '28', 'groupId': 'BG005'}, {'value': '168', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Normal Saline', 'description': 'Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil\n\nNormal Saline'}, {'id': 'BG001', 'title': 'Flurbiprofen AxetilⅠ', 'description': 'Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before anesthesia induction and intraoperative pain management was with remifentanil\n\nFlurbiprofen axetil: Flurbiprofen axetil is intravenously administrated'}, {'id': 'BG002', 'title': 'Flurbiprofen AxetilⅡ', 'description': 'Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before the skin closure and intraoperative pain management was with remifentanil\n\nFlurbiprofen axetil: Flurbiprofen axetil is intravenously administrated'}, {'id': 'BG003', 'title': 'Butorphanol', 'description': 'Butorphanol is intravenously administrated at a dose of 20μg/ kg before anesthesia induction and intraoperative pain management was with remifentanil.'}, {'id': 'BG004', 'title': 'Butorphanol-Flurbiprofen Axetil', 'description': 'A dose of 10μg/ kg butorphanol and a dose of 0.5mg/ kg flurbiprofen axetil are intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil.'}, {'id': 'BG005', 'title': 'Sufentanil', 'description': 'Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with sufentanil.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.2', 'spread': '11.0', 'groupId': 'BG000'}, {'value': '45.3', 'spread': '9.7', 'groupId': 'BG001'}, {'value': '47.9', 'spread': '10.0', 'groupId': 'BG002'}, {'value': '46.5', 'spread': '9.7', 'groupId': 'BG003'}, {'value': '45.1', 'spread': '7.9', 'groupId': 'BG004'}, {'value': '43.5', 'spread': '10.8', 'groupId': 'BG005'}, {'value': '45.5', 'spread': '9.8', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}, {'value': '28', 'groupId': 'BG005'}, {'value': '168', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}, {'value': '28', 'groupId': 'BG005'}, {'value': '168', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-08', 'studyFirstSubmitDate': '2014-01-15', 'resultsFirstSubmitDate': '2015-08-27', 'studyFirstSubmitQcDate': '2014-01-21', 'lastUpdatePostDateStruct': {'date': '2016-01-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-08-27', 'studyFirstPostDateStruct': {'date': '2014-01-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mechanical Hyperalgesia Threshold on the Dominant Inner Forearm', 'timeFrame': '24 hours after surgery', 'description': 'The mechanical hyperalgesia threshold was defined as the lowest force (g) necessary to bend a Von Frey filament, which was perceived to be painful by the patient and measured by Von Frey filament at 24 hours postoperatively'}], 'secondaryOutcomes': [{'measure': 'Pain Score (NRS)', 'timeFrame': '3h, 6h, 12h, and 24h after surgery', 'description': 'The pain score at rest was evaluated by pain 11-point numerical rating scale (NRS): 0 = no pain, 10 = greatest imaginable pain.'}, {'measure': 'Time of First Postoperative Analgesic Requirement', 'timeFrame': '1 hour post surgery', 'description': 'First postoperative pain (NRS≥5) is initially controlled by titration of sufentanyl.'}, {'measure': 'Occurrence of Side Effects', 'timeFrame': '24 hours', 'description': 'Occurrence of side effects: nausea, vomiting, dizziness, headache, shivering, pruritus'}, {'measure': 'Total Dose of First Postoperative Analgesic Requirement', 'timeFrame': '1 hour after surgery', 'description': 'First postoperative pain (NRS≥5) is initially controlled by titration of sufentanyl.'}, {'measure': 'Cumulative Sufentanyl Consumption', 'timeFrame': '24 hours', 'description': 'Each patient was administered analgesics using a PCA pump containing sufentanil (100μg) in normal saline at a total volume of 100 ml after leaving PACU. This device was set to deliver a basal infusion of 2 ml/h and bolus doses of 0.5 ml with a 15-min lockout period. Sufentanyl cumulative consumption is recorded 24 hours postoperatively'}, {'measure': 'Normalized Area of Hyperalgesia Around the Incision', 'timeFrame': '24 hours after surgery', 'description': "The skin around the incision is stimulated in steps of 5 mm at intervals of 1 s starting outside of the hyperalgesic area in the direction of the incision. The distance from the incision to the first point where a 'painful', 'sore' or 'sharper' feeling occurred is measured and noted. This measurement is repeated at predefined radial lines around the incision. To eliminate the variable length of incision, this length is subtracted from the longer diameter leaving four radial distances from the end and from the middle of the incision. The normalized area of hyperalgesia is calculated by summing up the areas of the remaining four triangles measured by and Von Frey filament."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Remifentanil', 'Opioid-induced hyperalgesia', 'Postoperative pain', 'Pain Intensity'], 'conditions': ['Pain', 'Anesthesia']}, 'referencesModule': {'references': [{'pmid': '28077539', 'type': 'DERIVED', 'citation': 'Zhang L, Shu R, Zhao Q, Li Y, Yu Y, Wang G. Preoperative butorphanol and flurbiprofen axetil therapy attenuates remifentanil-induced hyperalgesia after laparoscopic gynaecological surgery: a randomized double-blind controlled trial. Br J Anaesth. 2016 Oct;117(4):504-511. doi: 10.1093/bja/aew248. Epub 2016 Oct 17.'}]}, 'descriptionModule': {'briefSummary': 'Purpose:\n\nTo explore and compare antihyperalgesic effects of butorphanol, flurbiprofen axetil, and a combination of both received before anesthesia induction.\n\nTo evaluate and examine the incidence of adverse effects with the purpose of selecting the optimum dose.\n\n.', 'detailedDescription': 'There are a dramatically increasing number of evidences that administration of the potent, ultra-short-acting opioid remifentanil seems to cause opioid-induced hyperalgesia (OIH) more frequently and predictably compared with the others, likely due to its rapid onset and offset. Therefore, prophylaxis of remifentanil induced hyperalgesia is indispensable to postoperative comfort and satisfaction.\n\nThere is no denying the fact that OIH is related to central glutaminergic system and N-methyl-d-aspartate (NMDA) receptor-activation induced central sensitization. Prostaglandins can promote glutamate release from both astrocytes and spinal cord dorsal horns with subsequent activation of the NMDA receptors, and flurbiprofen axetil, as non-steroidal anti-inflammatory drugs (NSAIDs), not only functionally antagonizes the NMDA receptor activation via inhibition of prostaglandins, but also is a targeted drug which gathers at the site of inflammation, thus greatly enhances the analgesic effect. While butorphanol has both spinal analgesic and sedative functions because of predominantly central κ-receptor agonist activation, other advantages of butorphanol include few side effects, very low addiction potential, and low toxicity on account of a partial agonist-antagonist activity to μ-receptor. Moreover, antihyperalgesic activity of κ opioids at the site of inflammation has been reported in various acute pain models. The following study is carried out to evaluate whether butorphanol combined with flurbiprofen axetil can be safely and effectively applied to preventing postoperative hyperalgesia induced by remifentanil in patients undergoing lower abdominal surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subject is scheduled to undergo lower abdominal surgery under a short general anesthesia of less than 2 hours\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 renal or liver failure.\n2. Subject has a diagnosis of Insulin dependent diabetes.\n3. Subject is allergy and contraindication to butorphanol or NSAIDs.\n4. Subject has a history of chronic pain, a history of alcohol or opioid abuse, pre-existing therapy with opioids, intake of any analgesic drug within 48 hours before surgery.\n5. Subject has any contraindication for the use of patient-controlled analgesia (PCA).\n6. Subject is pregnant or breast-feeding.\n7. Subject is obese (body mass index \\>30kg/m\\^2)."}, 'identificationModule': {'nctId': 'NCT02043366', 'briefTitle': 'Effect of Butorphanol Combined With Flurbiprofen Axetil on Preventing Hyperalgesia Induced by Remifentanil in Patients', 'organization': {'class': 'OTHER', 'fullName': 'Tianjin Medical University General Hospital'}, 'officialTitle': 'Effect of Butorphanol Combined With Flurbiprofen Axetil on Preventing Postoperative Hyperalgesia Induced by Remifentanil in Patients Undergoing Lower Abdomimal Surgery', 'orgStudyIdInfo': {'id': 'GWang001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Normal Saline', 'description': 'Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil', 'interventionNames': ['Drug: Normal Saline', 'Drug: Remifentanil']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Butorphanol', 'description': 'Butorphanol is intravenously administrated at a dose of 20μg/ kg before anesthesia induction and intraoperative pain management was with remifentanil', 'interventionNames': ['Drug: Butorphanol', 'Drug: Remifentanil']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Flurbiprofen axetilⅠ', 'description': 'Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before anesthesia induction and intraoperative pain management was with remifentanil', 'interventionNames': ['Drug: Flurbiprofen axetil', 'Drug: Remifentanil']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Flurbiprofen axetilⅡ', 'description': 'Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before the skin closure and intraoperative pain management was with remifentanil', 'interventionNames': ['Drug: Flurbiprofen axetil', 'Drug: Remifentanil']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Butorphanol-Flurbiprofen axetil', 'description': 'A dose of 10μg/ kg butorphanol and a dose of 0.5mg/ kg flurbiprofen axetil are intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil', 'interventionNames': ['Drug: Butorphanol', 'Drug: Flurbiprofen axetil', 'Drug: Remifentanil']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sufentanil', 'description': 'Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with sufentanil', 'interventionNames': ['Drug: Normal Saline', 'Drug: Sufentanil']}], 'interventions': [{'name': 'Normal Saline', 'type': 'DRUG', 'description': 'Normal Saline is intravenously administrated before anesthesia induction', 'armGroupLabels': ['Normal Saline', 'Sufentanil']}, {'name': 'Butorphanol', 'type': 'DRUG', 'description': 'Butorphanol is intravenously administrated', 'armGroupLabels': ['Butorphanol', 'Butorphanol-Flurbiprofen axetil']}, {'name': 'Flurbiprofen axetil', 'type': 'DRUG', 'description': 'Flurbiprofen axetil is intravenously administrated', 'armGroupLabels': ['Butorphanol-Flurbiprofen axetil', 'Flurbiprofen axetilⅠ', 'Flurbiprofen axetilⅡ']}, {'name': 'Remifentanil', 'type': 'DRUG', 'description': 'Remifentanil is intravenously administrated', 'armGroupLabels': ['Butorphanol', 'Butorphanol-Flurbiprofen axetil', 'Flurbiprofen axetilⅠ', 'Flurbiprofen axetilⅡ', 'Normal Saline']}, {'name': 'Sufentanil', 'type': 'DRUG', 'description': 'Sufentanil is intravenously administrated', 'armGroupLabels': ['Sufentanil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '300052', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'Tianjin Medical University General Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'overallOfficials': [{'name': 'Guolin Wang, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tianjin Medical University General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tianjin Medical University General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Guolin Wang', 'investigatorAffiliation': 'Tianjin Medical University General Hospital'}}}}