Ignite Creation Date:
2025-12-24 @ 2:58 PM
Ignite Modification Date:
2025-12-26 @ 1:07 AM
Study NCT ID:
NCT06182059
Status:
RECRUITING
Last Update Posted:
2025-06-03
First Post:
2023-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Persistent Post Surgical Pain After Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], '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': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 436}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-28', 'studyFirstSubmitDate': '2023-12-05', 'studyFirstSubmitQcDate': '2023-12-13', 'lastUpdatePostDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Persistent post surgical pain', 'timeFrame': '0-6-month', 'description': 'Numeric rating score (0-10) over 4 at the follow up 6-month after total knee replacement'}], 'secondaryOutcomes': [{'measure': 'acute postoperative pain', 'timeFrame': '0-72 hours', 'description': 'Numeric rating score (0-10) over 4 in POD0, POD1, POD2, POD3'}, {'measure': 'Morphine requirement', 'timeFrame': '0-72 hours', 'description': 'total morphine administration via PCA in POD0, POD1, POD2, POD3'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['knee arthroplasty', 'acute postoperative pain', 'persistent post surgical pain', 'regional anesthesia'], 'conditions': ['Knee Arthropathy']}, 'descriptionModule': {'briefSummary': 'Patients undergone total knee replacement are randomized to receive a "fast track" regional anesthesia protocol or a "traditional" regional anesthesia continuous infusion by both a femoral and sciatic catheter to assess if this latter technique may reduce persistent postoperative pain six months after surgery', 'detailedDescription': 'Patients undergone to primary total knee replacement with spinal anesthesia are randomized to receive a continuous adductor canal block infusion + an ipack block or a continuous femoral nerve block + a continuous sciatic nerve block just at the end of surgery. Both group will receive a multimodal analgesia with paracetamol, ketorolac, desametasone and morphine as a rescue.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* primary total knee replacement with a written informed consent\n\nExclusion Criteria:\n\n* Allergy to local anesthetics or any drugs involve in the study\n* Controindication to regional anesthesia\n* chronic use of opioids\n* BMI \\> 35 kg m2'}, 'identificationModule': {'nctId': 'NCT06182059', 'briefTitle': 'Persistent Post Surgical Pain After Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Policlinico di Monza SpA'}, 'officialTitle': 'Enhanced Recovery After Surgery and Total Knee Replacement: A Prospective, Randomized Study on the Rule of Peripheral Nerve Blocks on Persistent Postoperative Pain Six Months After Surgery', 'orgStudyIdInfo': {'id': 'PPSP PTG'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'fast track', 'description': 'continuous adductor canal block and ipack block', 'interventionNames': ['Procedure: continuous peripheral nerve block']}, {'type': 'EXPERIMENTAL', 'label': 'traditional', 'description': 'continuous femoral nerve block and continuous sciatic block', 'interventionNames': ['Procedure: continuous peripheral nerve block']}], 'interventions': [{'name': 'continuous peripheral nerve block', 'type': 'PROCEDURE', 'description': 'continuous regional anesthesia in total knee replacement', 'armGroupLabels': ['fast track', 'traditional']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20900', 'city': 'Monza', 'state': 'Monza Brianza', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Gianluca Cappelleri, MD', 'role': 'CONTACT', 'email': 'gianluca.cappelleri@hotmail.com', 'phone': '+390392810941'}, {'name': 'Gianluca Perseghin, MD', 'role': 'CONTACT', 'email': 'gianluca.perseghin@policlinicodimonza.it', 'phone': '+3903928109'}], 'facility': 'Policlinico di Monza SPA', 'geoPoint': {'lat': 45.58005, 'lon': 9.27246}}], 'centralContacts': [{'name': 'Gianluca Cappelleri, MD', 'role': 'CONTACT', 'email': 'gianluca.cappelleri@policlinicodimonza.it', 'phone': '+390392810941'}, {'name': 'Gianluca Perseghin, MD', 'role': 'CONTACT', 'email': 'gianluca.perseghin@policlinicodimonza.it', 'phone': '+3903928109'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Policlinico di Monza SpA', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Gianluca Cappelleri', 'investigatorAffiliation': 'Policlinico di Monza SpA'}}}}