Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2026-02-27 @ 5:02 AM
Study NCT ID:
NCT06630520
Status:
COMPLETED
Last Update Posted:
2024-10-08
First Post:
2024-10-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intraoperative Periarticular Injection in Arthroscopic Anterior Cruciate Ligament Reconstruction Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D022125', 'term': 'Lacerations'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 288}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2023-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-04', 'studyFirstSubmitDate': '2024-10-04', 'studyFirstSubmitQcDate': '2024-10-04', 'lastUpdatePostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'drug related adverse events', 'timeFrame': 'within postoperative 2 weeks'}, {'measure': 'overall satisfaction scale (0-100 points)', 'timeFrame': 'at postoperative 2 weeks'}], 'primaryOutcomes': [{'measure': 'VAS scores', 'timeFrame': 'at different time points (postoperative 4,8,24-hour, before discharge) after surgery'}], 'secondaryOutcomes': [{'measure': 'cumulative morphine consumption (mg)', 'timeFrame': 'at post-operative 4, 8, 24-hour and before discharge'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['periarticular injection', 'morphine consumption', 'pain control'], 'conditions': ['Anterior Cruciate Ligament (ACL) Tear', 'Arthroscopic Anterior Cruciate Ligament Reconstruction']}, 'descriptionModule': {'briefSummary': 'In this prospective, assessor-blinded, single-surgeon clinical trial, the goal was to validate the efficacy of PAI in aACLR surgery with a reduced opioid dose, while achieving similar pain relief with few adverse events. 300 patients who had undergone aACLR were randomly allocated to receive either a PAI or nPAI group. The primary outcome parameters were visual analogue scale (VAS) scores and cumulative morphine dose, through time. Secondary outcome parameters included drug-related adverse events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\) Patients 18 years or older who had undergone a-ACLR with or without meniscus procedure for anterolateral instability of the knee; 2) agree to participate in this study and to be randomly allocated to either or peri-articular injection protocol and have signed an informed consent.\n\nExclusion Criteria:\n\n* 1\\) patients with other concomitant injuries such as other ligamentous injury or fracture; 2) Allergy to any of the medication used in either protocol; 3) patient with history of the chronic pain 4) preoperative chronic opioid-dependent patients (exceeding 50 mg oral morphine equivalence per day at time of recruitment); 5) refuse to participate in this study.'}, 'identificationModule': {'nctId': 'NCT06630520', 'acronym': 'PAI in ACLR', 'briefTitle': 'Intraoperative Periarticular Injection in Arthroscopic Anterior Cruciate Ligament Reconstruction Surgery', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Taipei Veterans General Hospital, Taiwan'}, 'officialTitle': 'Intraoperative Periarticular Injection May Improve Postoperative Pain Scores and Reduce Opioid Consumption in Arthroscopic Anterior Cruciate Ligament Reconstruction Surgery', 'orgStudyIdInfo': {'id': '2022-05-004B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Periarticular injection', 'interventionNames': ['Combination Product: Periarticular injection']}, {'type': 'NO_INTERVENTION', 'label': 'Control group'}], 'interventions': [{'name': 'Periarticular injection', 'type': 'COMBINATION_PRODUCT', 'description': 'A 50ml periarticular injection was introduced intraoperatively before the time of closing. The injection contained 150mg bupivacaine (3mg/mL), 60mg ketorolac(1.2mg/mL) and 1mg morphine.\n\nBefore wound closure, periarticular cocktail was injected around the knee joint including the adductor canal from the hamstring harvest side in PAI group. All patients had oral paracetamol 500mg, 4 times/day and diclofenac 75mg, 1 times/day after surgery.', 'armGroupLabels': ['Periarticular injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '112', 'city': 'Taipei', 'state': 'Taiwan', 'country': 'Taiwan', 'facility': 'Taipei Veterans General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Concerning the patient\\'s privacy'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Veterans General Hospital, Taiwan', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Division Director', 'investigatorFullName': 'En-Rung Chiang', 'investigatorAffiliation': 'Taipei Veterans General Hospital, Taiwan'}}}}