Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-29 @ 5:47 AM
Study NCT ID:
NCT04883034
Status:
UNKNOWN
Last Update Posted:
2021-05-12
First Post:
2021-04-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adductor Canal Block in Outpatient Clinic for Pain Control After Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059787', 'term': 'Acute Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000554', 'term': 'Ambulatory Care Facilities'}, {'id': 'D000700', 'term': 'Analgesics'}], 'ancestors': [{'id': 'D006268', 'term': 'Health Facilities'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D018689', 'term': 'Sensory System Agents'}, {'id': 'D018373', 'term': 'Peripheral Nervous System Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-06', 'studyFirstSubmitDate': '2021-04-30', 'studyFirstSubmitQcDate': '2021-05-06', 'lastUpdatePostDateStruct': {'date': '2021-05-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual analog pain score (VAS)', 'timeFrame': 'one month', 'description': 'A VAS scale was used to assess pain severity, with 0 indicating no pain and 10 indicating extreme pain'}], 'secondaryOutcomes': [{'measure': 'analgesic oral intake (etoricoxibe)', 'timeFrame': 'one month', 'description': 'determine how much analgesic (etoricoxibe) was consumed on a daily basis.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Pain', 'Total Knee Arthroplasty']}, 'descriptionModule': {'briefSummary': 'Single-shot Adductor Canal Block in the outpatient clinic is safe, significantly decreased pain and analgesic consumption and may enhance the rehabilitation program', 'detailedDescription': 'The ACB in the outpatient clinic is safe and can minimize postoperative pain. The primary goal of this research was to see how ACB affected the Visual Analog Score (VAS) pain score during the rehabilitation as opposed to controls. The secondary goal was to determine how much analgesic (etoricoxibe) was consumed on a daily basis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Indonesian or Javanese-speaking adults\n* After perfomed total knee replacement\n* American Society of Anesthesiologists physical status I-III\n* body mass index (BMI) of 18-40 kg/m2\n\nExclusion Criteria:\n\n* Declined to complete the study\n* Unable to cooperate\n* had an allergic reaction to any of the drugs\n* abusing alcohol or drugs'}, 'identificationModule': {'nctId': 'NCT04883034', 'acronym': 'ACB', 'briefTitle': 'Adductor Canal Block in Outpatient Clinic for Pain Control After Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Gadjah Mada University'}, 'officialTitle': 'Adductor Canal Block in Outpatient Clinic', 'orgStudyIdInfo': {'id': 'ACB OUTPATIENT CLINIC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'pain management post total knee arthroplasty with analgetic oral', 'description': 'Patients in control group were given analgesic (etoricoxibe) on a daily basis, with the option to increase the dose if pain persisted, up to a maximum of 120 mg per day.', 'interventionNames': ['Drug: Analgesics, etoricoxibe']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'pain management post total knee arthroplasty with adductor canal block', 'description': 'On postoperative day 14 (POD 14), the ACB was performed for ACB group', 'interventionNames': ['Procedure: adductor canal block in outpatient clinic']}], 'interventions': [{'name': 'adductor canal block in outpatient clinic', 'type': 'PROCEDURE', 'description': 'perform adductor canal block in outpatient clinic for patient post total knee arthroplasty', 'armGroupLabels': ['pain management post total knee arthroplasty with adductor canal block']}, {'name': 'Analgesics, etoricoxibe', 'type': 'DRUG', 'otherNames': ['etoricoxibe'], 'description': 'anaelgetic oral intake', 'armGroupLabels': ['pain management post total knee arthroplasty with analgetic oral']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55281', 'city': 'Sleman', 'state': 'Special Region of Yogyakarta', 'status': 'RECRUITING', 'country': 'Indonesia', 'contacts': [{'name': 'sholahuddin rhatomy, Dr', 'role': 'CONTACT', 'email': 'sholahuddin.rhatomy@ugm.ac.id', 'phone': '+6281808720707'}], 'facility': 'Sholahuddin Rhatomy', 'geoPoint': {'lat': -7.71556, 'lon': 110.35556}}], 'centralContacts': [{'name': 'sholahuddin rhatomy, Dr', 'role': 'CONTACT', 'email': 'sholahuddin.rhatomy@ugm.ac.id', 'phone': '+6281808720707'}], 'overallOfficials': [{'name': 'sholahuddin rhatomy, dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gadjah Mada University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gadjah Mada University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head Of orthopaedic and Traumatology Department, Dr Soeradji Tirtonegoro Hospital/Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada', 'investigatorFullName': 'Sholahuddin Rhatomy', 'investigatorAffiliation': 'Gadjah Mada University'}}}}