Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-02-20 @ 10:44 PM
Study NCT ID:
NCT03692858
Status:
UNKNOWN
Last Update Posted:
2019-10-22
First Post:
2018-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IPACK Block in Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2020-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-21', 'studyFirstSubmitDate': '2018-09-30', 'studyFirstSubmitQcDate': '2018-09-30', 'lastUpdatePostDateStruct': {'date': '2019-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'NRS scores', 'timeFrame': '48 hours', 'description': 'Numerical Rating Scale (NRS) scores (Range 0-10, 0=no pain, 10=the worse pain ever)'}, {'measure': 'Morphine consumption', 'timeFrame': '24 hours', 'description': 'Morphine consumption in mg'}, {'measure': 'Chronic pain', 'timeFrame': '6 months', 'description': 'Using of Graded Chronic Pain Scale (GCPS) Grade 0: No pain in prior 6 months Grade 1: Low Intensity - Low Disability Grade II: High Intensity Characteristic Pain Intensity - Low Disability Grade III: High Disability - Moderately Limiting Grade IV: High Disability - Severely Limiting'}], 'secondaryOutcomes': [{'measure': 'Delirium occurence', 'timeFrame': '48 hours', 'description': 'Nu-DESK scale (presence of disorientation, inappropriate behavior, inappropriate communication,illusions/hallucinations, psychomoter retardation). Each of the 5 items is rated from 0 to 2. A total of 10 is the maximum score. A score of more than 2 identifies the presence of delirium.'}, {'measure': 'Range of knee motion', 'timeFrame': '48 hours', 'description': 'Degrees of flexion'}, {'measure': 'Complications', 'timeFrame': '48 hours'}, {'measure': 'Patient mobilization', 'timeFrame': '5 days', 'description': 'Patient reporting time of first standing to the side of the bed and number of steps per day'}, {'measure': 'Patient satisfaction', 'timeFrame': '48 hours', 'description': 'Patients asked whether they would choose the same anaesthetic management in a future operation: Yes/No'}, {'measure': 'Joint function', 'timeFrame': '6 months', 'description': 'Maximal flexion / extension'}, {'measure': 'Intestinal function', 'timeFrame': '5 days', 'description': 'Time of first passing of rectal gas, reported by the patient'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['arthroplasty', 'replacement', 'knee'], 'conditions': ['Total Knee Arthroplasty']}, 'descriptionModule': {'briefSummary': '100 patients ASA I-III, undergoing total knee arthroplasty under spinal anesthesia, will be randomly assigned into one of two groups, namely group A (n=50), where an adductor canal block and an IPACK block will be performed preoperatively and group B (n=50) where an adductor canal block only will be performed preoperatively. All patients will receive a standardized multimodal approach, including pregabalin, paracetamol, and PCA with morphine. NRS scores in static and dynamic conditions during the first 48 hours postoperatively, morphine consumption during the first 24 hours postoperatively will be measured and additionally, patient satisfaction, complications, range of knee motion, moblization, functionality, delirium ocurence will be recorded. Chronic pain will be assessed in 3 and 6 months postoperatively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Physical status according to American Society of Anesthesiologists (ASA) I-III\n* Patients scheduled for total knee arthroplasty\n\nExclusion Criteria:\n\n* Previous operation on same knee\n* Contraindication of spinal anesthesia, peripheral nerve blocks or any of the agents used in the protocol\n* BMI above 32\n* Serious psychiatric, mental and cognitive disorders\n* Language barrier\n* Block failure\n* Chronic opioid, gabapentinoid use\n* Severe kidney disfunction'}, 'identificationModule': {'nctId': 'NCT03692858', 'briefTitle': 'IPACK Block in Total Knee Arthroplasty', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Asklepieion Voulas General Hospital'}, 'officialTitle': 'IPACK Block Efficacy as a Part of Multimodal Analgesia in Total Knee Arthroplasty. A Prospective, Randomized, Controlled, Double Blinded Study', 'orgStudyIdInfo': {'id': '8885/20-06-2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A', 'interventionNames': ['Drug: Adductor Canal Block plus IPACK Block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', 'interventionNames': ['Drug: Adductor Canal Block']}], 'interventions': [{'name': 'Adductor Canal Block plus IPACK Block', 'type': 'DRUG', 'description': 'Adductor Canal Block plus IPACK Block using Ropivacaine', 'armGroupLabels': ['Group A']}, {'name': 'Adductor Canal Block', 'type': 'DRUG', 'description': 'Adductor Canal Block using Ropivacaine', 'armGroupLabels': ['Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16673', 'city': 'Athens', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Alexandros Makris, Dr', 'role': 'CONTACT'}], 'facility': 'Asklepieion Hospital of Voula', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}], 'centralContacts': [{'name': 'Alexandros Makris', 'role': 'CONTACT', 'email': 'makrisalexandros@hotmail.com', 'phone': '+306947076446'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asklepieion Voulas General Hospital', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Aikaterini Kalampokini', 'class': 'UNKNOWN'}, {'name': 'Chryssoula Staikou', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Anesthesiologist', 'investigatorFullName': 'Alexandros Makris', 'investigatorAffiliation': 'Asklepieion Voulas General Hospital'}}}}