Ignite Creation Date:
2025-12-24 @ 1:57 PM
Ignite Modification Date:
2026-01-13 @ 4:19 AM
Study NCT ID:
NCT01960595
Status:
UNKNOWN
Last Update Posted:
2013-10-10
First Post:
2013-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-operative Pain Management In Patients Undergoing Hullax Valgus Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009407', 'term': 'Nerve Block'}], 'ancestors': [{'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D003714', 'term': 'Denervation'}, {'id': 'D019635', 'term': 'Neurosurgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2014-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-10-09', 'studyFirstSubmitDate': '2013-09-13', 'studyFirstSubmitQcDate': '2013-10-09', 'lastUpdatePostDateStruct': {'date': '2013-10-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'assessment of cost analysis among groups', 'timeFrame': 'surgery period and 36 hours after surgery'}], 'primaryOutcomes': [{'measure': 'provides adequate pain relief and decreases fentanyl consumption', 'timeFrame': 'including of surgery and 36 hours after surgery', 'description': 'Patients are subgrouping into groups of post-OP IV fentanyl PCA only, pretreatment of local bupivacaine infiltration and post-OP IV fentanyl PCA, and pretreatment of peroneal nerves block and post-OP IV fentanyl PCA. Resting pain and moving pain scores are measured by the numeric rating scale and classified into none, mild, moderate and severe pain four grades. Pains scale and side effects are recorded at time intervals of post-OP 0 hours, 6 hours, 12 hours, 24 hours, and 36 hours after surgery.'}], 'secondaryOutcomes': [{'measure': 'incidence of side effects and complications', 'timeFrame': 'intraoperatively and 36 hours after surgery', 'description': 'side effects include of intraoperative hypo-tension,dizziness, nausea, and vomiting.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['PCA,Nerve block,Hullax Valgus'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the efficacy and cost analysis of intravenous fentanyl combined with either local anesthesia infiltration or peroneal nerves block in patients with Hallux Valgus undergoing orthopedic corrective surgery and compared with patients without local anesthetics administration perioperatively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. patients with American Society of Anesthesiologists physical status I-III\n2. aged 20-65 years\n3. Requiring local anesthesia and PCA use\n4. No severe cardiac or pulmonary diseases\n5. BMI \\<35 kg/m2\n\nExclusion Criteria:\n\n1. BMI ≧35 kg/m2\n2. age \\> 65years\n3. allergy to opioid or local anesthetics'}, 'identificationModule': {'nctId': 'NCT01960595', 'briefTitle': 'Post-operative Pain Management In Patients Undergoing Hullax Valgus Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Kaohsiung Medical University Chung-Ho Memorial Hospital'}, 'officialTitle': 'Comparison of the Efficacy and Cost Analysis of Regional Anesthesia and Intravenous Fentanyl for Postoperative Pain Management in Patients Undergoing Hullax Valgus Surgery', 'orgStudyIdInfo': {'id': 'KMUH-IRB-20120357'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IV fentanyl PCA', 'description': 'The patient receives post-OP IV fentanyl PCA', 'interventionNames': ['Procedure: IV fentanyl PCA']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'post-OP IV fentanyl PCA and local infiltration', 'description': 'pretreatment of local infiltration 0.25% bupivacaine 5 ml and post-OP IV fentanyl PCA', 'interventionNames': ['Procedure: local bupivacaine infiltration and post-OP IV fentanyl PCA']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'nerves block and post-OP IV fentanyl PCA', 'description': 'pretreatment of peroneal nerves 0.25% bupivacaine 10 ml and post-OP IV fentanyl PCA', 'interventionNames': ['Procedure: Nerve Blocks and post-OP IV fentanyl PCA']}], 'interventions': [{'name': 'IV fentanyl PCA', 'type': 'PROCEDURE', 'armGroupLabels': ['IV fentanyl PCA']}, {'name': 'local bupivacaine infiltration and post-OP IV fentanyl PCA', 'type': 'PROCEDURE', 'armGroupLabels': ['post-OP IV fentanyl PCA and local infiltration']}, {'name': 'Nerve Blocks and post-OP IV fentanyl PCA', 'type': 'PROCEDURE', 'armGroupLabels': ['nerves block and post-OP IV fentanyl PCA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '807', 'city': 'Kaohsiung City', 'state': 'Kaohsiung', 'country': 'Taiwan', 'facility': 'Kaohsiung Medical University Chung-Ho Memorial Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}], 'overallOfficials': [{'name': 'Peng Ju Huang, MD, PhD.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of orthopaedic surgery, Kaohsiung Medical University, Taiwan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaohsiung Medical University Chung-Ho Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}