Ignite Creation Date:
2025-12-24 @ 6:41 PM
Ignite Modification Date:
2025-12-27 @ 12:46 PM
Study NCT ID:
NCT00314457
Status:
TERMINATED
Last Update Posted:
2009-07-13
First Post:
2006-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Study of Continuous Intraarticular Infusion in Patients Undergoing Arthroscopic Knee and Shoulder Operations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'whyStopped': 'Bupivacaine has recently been shown to inhibit osteoclast formation in vitro.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-07-10', 'studyFirstSubmitDate': '2006-04-12', 'studyFirstSubmitQcDate': '2006-04-12', 'lastUpdatePostDateStruct': {'date': '2009-07-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-04-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the total amount of opioids and other analgesic medications consumed in the recovery room and during the 48 hour study period (intravenous and oral).', 'timeFrame': '48 hour post operatively'}], 'secondaryOutcomes': [{'measure': "Secondary endpoints will include the incidence of side effects, such as nausea, vomiting, sedation and itching, pain scores at defined time periods and patients' satisfaction.", 'timeFrame': '48 hours post operatively'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pain control', 'intra-articular pain control device', 'ACL repair', 'Bankart Repair'], 'conditions': ['ACL Repair', 'Meniscectomy', 'Bankart Repair']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine whether the continuous intraarticular infusion of local anesthetics in the postoperative period can improve analgesia and patients satisfaction after knee and shoulder arthroscopy.', 'detailedDescription': 'We propose to evaluate the long-term efficacy of the continuous intraarticular delivery of local anesthetics via a disposable, self-regulated DonJoy Pain Control infusion pump. Patients will be randomly assigned to receive either an intra-articular infusion of bupivacaine 0.125%, or saline delivered at a rate of 5 ml/hr for 48 hours by a DonJoy® Pain Control infusion pump. Patients will receive a femoral block (FNB) and a sciatic block (SNB) for knee arthroscopy or an interscalene block (INB) for shoulder arthroscopy prior to surgery. After the operation, patients will receive morphine via a Patient Controlled Analgesia (PCA) pump for pain control. The patient will be admitted overnight to a Care Unit, with the PCA discontinued at discharge or 24 hours, whichever is earlier. If clinically indicated, the PCA may be extended at the discretion of the pain team. Upon discharge and during the 48 hour study period the patient will receive oral oxycodone and acetaminophen. The patient and their family will remove the DonJoy® Pain Control infusion pump 48 hours after the surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '11 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children between the ages of 11 and 19 years old.\n* Knee and shoulder arthroscopy procedures\n\nExclusion Criteria:\n\n* Contraindications to Femoral-Interscalene Nerve Block\n* Conditions that affect the proper evaluation of pain and side effects.\n* Intake of NSAIDs or opioids in the 12 hours prior to the operation\n* Allergy to study medications'}, 'identificationModule': {'nctId': 'NCT00314457', 'briefTitle': 'Efficacy Study of Continuous Intraarticular Infusion in Patients Undergoing Arthroscopic Knee and Shoulder Operations', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Philadelphia"}, 'officialTitle': 'A Randomized, Double-blind Trial Comparing the Analgesic Efficacy and Side Effects of Continuous Intraarticular Infusion of Bupivacaine Versus Normal Saline in Patients Undergoing Knee and Shoulder Operations', 'orgStudyIdInfo': {'id': '2005-5-4294'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Bupivacaine', 'type': 'DRUG', 'description': 'Patients receive either normal saline or Bupivacaine in normal saline that infuses intraarticularly for 48 hours.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "The Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Harshad Gurnaney, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Philadelphia"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Philadelphia", 'class': 'OTHER'}, 'collaborators': [{'name': "Children's Anesthesiology Associates, Ltd.", 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Harshad Gurnaney, MBBS', 'oldOrganization': "The Children's Hospital of Philadelphia"}}}}