Ignite Creation Date:
2025-12-25 @ 1:04 AM
Ignite Modification Date:
2026-01-03 @ 10:04 PM
Study NCT ID:
NCT03414593
Status:
UNKNOWN
Last Update Posted:
2018-01-30
First Post:
2018-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preemptive Analgesic Effects of Popliteal Sciatic Nerve Block in Patients With Bilateral Hallux Valgus Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D059787', 'term': 'Acute Pain'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients who underwent surgery on both feet at the same time. One foot is performed before surgery and the other is performed after surgery.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-01-26', 'studyFirstSubmitDate': '2018-01-15', 'studyFirstSubmitQcDate': '2018-01-26', 'lastUpdatePostDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Analgesic duration of nerve block', 'timeFrame': 'at 0, 0.5, 1, 4, 8, 12 hours after operation. And AM 9 and PM 5 of POD (Post Operative Day) 1', 'description': 'The difference of NRS during study time between group preB and group postB\n\nThe Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. It is for adults and children 10 years old or older.\n\n0: No pain, 1-3: mild pain, 4-6: Moderate pain, 7-10: severe pain, 10: worst pain imaginable.'}], 'secondaryOutcomes': [{'measure': 'Difference of analgesic consumption between both group', 'timeFrame': 'at 0, 0.5, 1, 4, 8, 12 hours after operation. And AM 9 and PM 5 of POD (Post Operative Day) 1', 'description': 'The difference of usage of rescue analgesics during study time between group preB and group postB after the operation'}, {'measure': 'side effect of popliteal sciatic nerve block', 'timeFrame': 'at 0, 0.5, 1, 4, 8, 12 hours after operation. And AM 9 and PM 5 of POD (Post Operative Day) 1', 'description': 'any other sensation except pain'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['preemptive analgic effect', 'popliteal sciatic nerve block', 'Bilateral Hallux Valgus'], 'conditions': ['Pain, Postoperative', 'Preemptive Peripheral Nerve Block', 'Acute Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to investigate the preemptive effect of ultrasound guided popliteal scistic nerve block on postoperative acute pain in patients with bilateral hallux valgus.\n\nAfter induction of general anesthesia, the leg to be operated first is decided randomly. After the operation of one leg is completed, PSNB is performed on both legs with 0.2% Ropivacaine and surgery is started on the remaining legs.\n\nWhen the surgery is over, check to see which foot pain begins first, how strong the pain is, and whether there are any side effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. adults between the ages of 20 and 80\n2. bilateral hallux valgus surgery on the same day\n3. ASA class 1 or 2\n4. Patients who have voluntarily agreed in writing to participate in the trial\n\nExclusion Criteria:\n\n1. Patient with side effects on local anesthetics or steroids\n2. Patient who are taboo of peripheral nerve block such as blood clotting disorder, infection, etc.\n3. Patients with uncontrolled medical or psychiatric problem\n4. Patient does not agree to participate in the study\n5. Patients who are pregnant or lactating'}, 'identificationModule': {'nctId': 'NCT03414593', 'briefTitle': 'Preemptive Analgesic Effects of Popliteal Sciatic Nerve Block in Patients With Bilateral Hallux Valgus Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'Prospective, Randomized, Single Blind Trial of Preemptive Analgesic Effects of Popliteal Sciatic Nerve Block in Patients With Bilateral Hallux Valgus Surgery', 'orgStudyIdInfo': {'id': '2017-0856'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'preoperative blocked leg: group preB', 'description': 'ultrasound guided popliteal sciatic nerve block with 0.2% ropivacaine 20ml Before surgical incision', 'interventionNames': ['Drug: Ultrasound guided popliteal sciatic nerve block with 0.2% ropivcaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'postoperative blocked leg: group postB', 'description': 'ultrasound guided popliteal sciatic nerve block with 0.2% ropivacaine 20ml After surgical incision', 'interventionNames': ['Drug: Ultrasound guided popliteal sciatic nerve block with 0.2% ropivcaine']}], 'interventions': [{'name': 'Ultrasound guided popliteal sciatic nerve block with 0.2% ropivcaine', 'type': 'DRUG', 'description': 'Ultrasound guided popliteal sciatic nerve block with 0.2% ropivacaine 20ml', 'armGroupLabels': ['postoperative blocked leg: group postB', 'preoperative blocked leg: group preB']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05505', 'city': 'Seoul', 'state': 'Songpa-gu', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'JongHyuk Lee, md', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asan Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'clinical assistant professor', 'investigatorFullName': 'Jong Hyuk Lee', 'investigatorAffiliation': 'Asan Medical Center'}}}}