Ignite Creation Date:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2025-12-24 @ 4:45 PM
Study NCT ID:
NCT03913650
Status:
COMPLETED
Last Update Posted:
2020-02-18
First Post:
2017-09-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Influence of Peripheral Nerve Blocks in Patients Undergoing Limb Orthopedic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D007431', 'term': 'Intraoperative Complications'}], 'ancestors': [{'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': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D009407', 'term': 'Nerve Block'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-15', 'studyFirstSubmitDate': '2017-09-17', 'studyFirstSubmitQcDate': '2019-04-11', 'lastUpdatePostDateStruct': {'date': '2020-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'changes of perioperative hemodynamic parameter', 'timeFrame': 'up to 3 hours', 'description': 'heart rate'}, {'measure': 'changes of perioperative hemodynamic parameter', 'timeFrame': 'up to 3 hours', 'description': 'blood pressure'}], 'primaryOutcomes': [{'measure': 'peak pain intensity in the postoperative care unit', 'timeFrame': '2 hours', 'description': 'pain score evaluated by pain score'}], 'secondaryOutcomes': [{'measure': 'change of perioperative IL-6 level', 'timeFrame': 'up to 6 hours', 'description': 'blood samples assessed by ELISA'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['peripheral nerve block', 'IL-6', 'post-operative pain', 'limb surgery'], 'conditions': ['Pain, Postoperative', 'Change; Circulatory', 'Surgical Injury']}, 'descriptionModule': {'briefSummary': 'To investigate pre-op peripheral nerve block in reducing peri-op IL-6 level and post-op pain', 'detailedDescription': 'In orthopedic surgery, peripheral nerve block can be used as an anesthesia adjuvant prior to surgery. In this study, we hypothesized that peripheral nerve blocks may alleviate inflammatory response and reduce the analgesics requirement. Sixty patients undergoing limb orthopedic surgery will be enrolled. Peripheral nerve block was injected with 0.25% bupivacaine under ultrasound guidance. 30 patients (Study group) underwent surgery with nerve blocks and another 30 patients (Control group) underwent surgery with morphine. The anesthetic protocol was standardized for both groups by experienced anesthesiologists. Surgical stress was assessed by blood pressure fluctuation and proinflammatory cytokine. Pain intensity was measured by numeric rating scale (NRS) score for 24 hours'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of limb fracture\n* must receiving orthopedic surgery\n\nExclusion Criteria:\n\n* With the comorbidity of chronic heart, lung, liver and renal disease, Chronic alcoholism, Allergy to bupivacaine'}, 'identificationModule': {'nctId': 'NCT03913650', 'briefTitle': 'The Influence of Peripheral Nerve Blocks in Patients Undergoing Limb Orthopedic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Kaohsiung Medical University Chung-Ho Memorial Hospital'}, 'officialTitle': 'Preoperative Peripheral Nerve Blocks Attenuate Intraoperative Surgical Stress and Postoperative Pain in Patients Undergoing Orthopedic Surgery', 'orgStudyIdInfo': {'id': 'KMUH-IRB-F(I)-20170007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Nerve block(+)', 'description': 'patient accept nerve block for post-op pain control', 'interventionNames': ['Procedure: 0.25% bupivacaine']}, {'type': 'SHAM_COMPARATOR', 'label': 'Morphine', 'description': 'patient received morphine for post-op pain control', 'interventionNames': ['Procedure: 0.25% bupivacaine']}], 'interventions': [{'name': '0.25% bupivacaine', 'type': 'PROCEDURE', 'otherNames': ['nerve block with 0.25% bupivacaine'], 'description': "nerve block procedure will be decided by patients' will for post-op pain", 'armGroupLabels': ['Morphine', 'Nerve block(+)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '807', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'I-Cheng Lu', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'zip': '812', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Kaohsiung Municipal Siaogang Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}], 'overallOfficials': [{'name': 'I-Cheng Lu, MD, PHD', 'role': 'STUDY_CHAIR', 'affiliation': 'Kaohsiung Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaohsiung Medical University Chung-Ho Memorial Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kaohsiung Municipal Hsiaokang Hospital', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Visiting staff', 'investigatorFullName': 'I-Cheng Lu', 'investigatorAffiliation': 'Kaohsiung Medical University Chung-Ho Memorial Hospital'}}}}