Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-30 @ 6:22 PM
Study NCT ID:
NCT01345604
Status:
COMPLETED
Last Update Posted:
2016-11-15
First Post:
2011-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intraoperative Posterior Cruciate Ligament (Transcruciate) Injection After Total Knee Arthroplasty (TKA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077212', 'term': 'Ropivacaine'}], '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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-10', 'studyFirstSubmitDate': '2011-04-28', 'studyFirstSubmitQcDate': '2011-04-29', 'lastUpdatePostDateStruct': {'date': '2016-11-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Knee flexion', 'timeFrame': 'up to one week postoperative'}], 'secondaryOutcomes': [{'measure': 'Postoperative pain score', 'timeFrame': 'in PACU , on ward (baseline), and post-op day 1 & 2 at 10am & 6pm', 'description': 'Pain scores will be recorded at rest and on attempt of achieving a 90 degree passive flexion of the knee.'}, {'measure': 'Total narcotic consumption', 'timeFrame': 'up to 1 week postoperative'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Arthroplasty, Replacement, Knee']}, 'descriptionModule': {'briefSummary': 'his study is being done because total knee replacements can leave patients with considerable pain after surgery. Therefore, many studies have been done to find the best ways to control knee pain after the surgery. Currently, a popular approach is to use many different techniques to control the pain. This includes injecting freezing (local anesthetic) into the spinal column (spinal anesthetic), injecting freezing close to the nerves of the knee and using various kinds of medications (e.g. narcotics and anti-inflammatory medications). Studies have shown using this a combination of techniques can reduce pain and allow earlier discharge from the hospital. However, one downside to this approach is it does not usually control the pain in the back of the knee. One new technique has been used to try and overcome this. This technique is called a "posterior cruciate ligament block" or "PCL block". It involves injecting a drug into the back of the knee which will block the nerves in this area. Sometimes the investigators refer to this as "freezing".\n\nThe purpose of our study is to determine whether this "PCL Block" will improve pain after the total knee replacement surgery. The investigators will also determine whether this technique will improve movement in the knee and lessen narcotic usage after the surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* American Society of Anesthesiologists' (ASA) physical status classification (ASA) I and II patients undergoing unilateral total knee arthroplasty at Saskatoon City Hospital\n* Patients recruited from the practice of 4 orthopedic surgeons\n\nExclusion Criteria:\n\n* Inability to obtain informed consent\n* Simultaneous bilateral total knee arthroplasty or revision cases\n* Preexisting neurological deficits in the distribution of the femoral nerve or known diagnosis of peripheral neuropathy\n* Coagulopathies\n* Infection either systemically or at the needle insertion sites\n* Allergies to local anesthetics or opioids\n* Patients with a history of narcotic dependency or chronic pain\n* ASA III and IV\n* Body Mass Index (BMI) \\> 40"}, 'identificationModule': {'nctId': 'NCT01345604', 'briefTitle': 'Intraoperative Posterior Cruciate Ligament (Transcruciate) Injection After Total Knee Arthroplasty (TKA)', 'organization': {'class': 'OTHER', 'fullName': 'University of Saskatchewan'}, 'officialTitle': 'Reducing Posterior Knee Pain Following Total Knee Arthroplasty Using an Intraoperative Posterior Cruciate Ligament (Transcruciate) Injection', 'orgStudyIdInfo': {'id': 'PCL block'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Saline', 'interventionNames': ['Procedure: transcruciate injection of 20cc of normal saline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ropivicaine', 'interventionNames': ['Procedure: transcruciate injection of 20 cc of 0.5% Ropivacaine']}], 'interventions': [{'name': 'transcruciate injection of 20cc of normal saline', 'type': 'PROCEDURE', 'description': 'Group 2 (control group) will receive a transcruciate injection of 20cc of normal saline through the posterior cruciate ligament during the procedure (in addition to a subarachnoid block and femoral nerve block pre-operatively).', 'armGroupLabels': ['Saline']}, {'name': 'transcruciate injection of 20 cc of 0.5% Ropivacaine', 'type': 'PROCEDURE', 'description': 'Group 1 (study group) will receive a transcruciate injection of 20 cc of 0.5% Ropivacaine through the posterior cruciate ligament during the procedure (in addition to a subarachnoid block and femoral nerve block pre-operatively).', 'armGroupLabels': ['Ropivicaine']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'S7K 5T6', 'city': 'Saskatoon', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'Saskatoon City Hospital', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Saskatchewan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Saskatoon Health Region', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Faculty', 'investigatorFullName': 'Jacelyn Larson', 'investigatorAffiliation': 'University of Saskatchewan'}}}}