Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2025-12-31 @ 1:34 AM
Study NCT ID:
NCT02314832
Status:
COMPLETED
Last Update Posted:
2017-03-30
First Post:
2014-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk of Falling After CFNB Versus ACB
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-28', 'studyFirstSubmitDate': '2014-07-01', 'studyFirstSubmitQcDate': '2014-12-10', 'lastUpdatePostDateStruct': {'date': '2017-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'risk of falling score', 'timeFrame': '24 hours after surgery', 'description': 'The percentage of patients at high risk of falls as evaluated by Tinetti score in both groups.\n\nScores of 19 or less are usually associated with higher risk of falls.'}], 'secondaryOutcomes': [{'measure': 'Pain scores', 'timeFrame': '48 hours', 'description': 'pain scores at rest and with movement'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['femoral nerve block', 'adductor canal block', 'tinetti score', '2- Results to time to up and go (TUG ) test', '3- Results to Tinetti test', '4- Ambulation distance', '5- Pain scores at rest and with movement'], 'conditions': ['Falls', 'Total Knee Arthroplasty (TKA)', 'Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'Blocking sensation from the femoral nerve by injecting local anesthetic around the nerve plays an important role in pain control after total knee replacement. However, femoral nerve block has been associated with increased risk of falls due to weakness of the thigh muscle. This prospective, randomized controlled trial asks the question whether blocking the more distal branch of the femoral nerve (saphenous nerve) will result in less muscle motor block, and thus less risk of falls. The study also aims to compare pain control after both techniques.', 'detailedDescription': 'If the patient is willing to participate and signs the consent, he/she will be randomized to one of the two treatment groups:\n\n1. Femoral nerve block\n2. Adductor canal block\n\nThe standard of care anesthesia regimen for this surgery is as follows:\n\nAll Patients will receive their Multimodal Perioperative Pain Protocol (MP3) medication as per routine care in the patient receiving area. All blocks are performed in the pre-operative holding area with standard ASA monitors applied. Typically, patients receive 1-2 mg of midazolam and 50-100 mcg of fentanyl for sedation during the placement of the block. Standard operating procedure of the block room will be followed. Block time out will be preformed according to standard operating procedure. All blocks will be done under ultrasound guidance. Sonosite (S nerve) machine will be used with a high frequency linear (HFL) US probe with 6-13 MHZ frequency. Both CFNB and ACB will take be performed according to the SOP in the investigators department.\n\nFor CFNB: Images of the femoral nerve will be obtained in the short axis. 1% lidocaine will be used for local infiltration of the skin. A 2 inch 18 G touhy needle ( B Braun) will be advanced in plane under US guidance . Confirmation may take place with Quadricpes muscle twitches and patella movement between 0.3 and 0.4mA (2Hz; 0.1ms). A bolus of 20 ml of Ropivicaine 0.5% will be injected. A non stimulating catheter will be advanced through the needle to a distance of 3-4 cm beyond the needle tip. Catheter will be secured in place using benzoin, Steristrips, and a tegaderm.\n\nFor the ACB: ultrasound survey at the medial part of the thigh will take place, halfway between the superior anterior iliac spine and the patella. In a short axis view, the femoral artery will be identified underneath the sartorius muscle, with the vein just inferior and the saphenous nerve just lateral to the artery. The needle will be introduced in-plane and 2 to 3 mL of LA bolus (0.2% ropivicaine) will be used to verify correct placement of the needle in the vicinity of the saphenous nerve in the adductor canal. A bolus of total volume of 20 ml of Ropivicaine 0.5% will be injected through the needle. The catheter will then be introduced and advanced 2-3 cm beyond the tip of the needle.\n\nAt the conclusion of surgery a large obaque dressing will be applied from the femoral crease to the mid thigh region so that the catheter location will be concealed. Both catheters will be connected to a pump that will infuse local anesthetic. Ropivicaine 0.2% at 8 ml/hour. There is usually a period of time before the patient transport to the operating room during which the investigators will be able to evaluate if the block is effective and sufficient for surgery.\n\nPatients will receive either general or spinal anesthesia in the operating room. All patients will receive prophylaxis for nausea and vomiting during surgery. Regimen for prophylaxis include a single dose of dexamethasone after induction of anesthesia and a single dose of Ondansetron 20 minutes before recovery from anesthesia. This study is not deviating from the standard of care anesthetic regimen for this surgical procedure at Penn Presbyterian Medical Center. Only the type of blocks will be different between the two groups.\n\nPostoperative analgesia All PACU analgesia will follow standard of care protocol for post operative care at PPMC. Hydromorphone 0.2 mg iv q5 minutes as necessary. The infusion of the local anesthetic will start in the PACU.\n\nIn the PACU, patients are assessed for pain with the Visual Analog Scale (pain scale of 1 to 10) at routine time points for the duration of their stay. The worse VAS score will be recorded.\n\nPostoperative Analgesia\n\nPostoperative analgesia will follow the MP3 protocol. The protocol includes administration of around the clock acetaminophen, Celebrex, gabapentin, immediate and extended release oxycodone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for primary total knee arthroplasty\n* American Society of Anesthesiologists (ASA) physical status I -III\n* mentally competent and able to give consent for enrollment in the study\n\nExclusion Criteria:\n\n1. Patient younger than 18 years old\n2. Allergy to local anesthetics, systemic opioids (fentanyl, morphine, hydromorphone, and any of the drugs included in the multimodal perioperative pain protocol (MP3).\n3. Revision surgery will be excluded.\n4. Impaired kidney functions and patient with coagulopathy will also be excluded.\n5. Chronic pain syndromes; Patients will be defined to have chronic pain if they are using regular daily doses of systemic narcotics for the past 3 months prior to the surgery.\n6. BMI of 40 or more\n7. Pregnancy (positive urine pregnancy test result in Preop area on morning of surgery)'}, 'identificationModule': {'nctId': 'NCT02314832', 'briefTitle': 'Risk of Falling After CFNB Versus ACB', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Comparison Between the Risk Falls After Total Knee Arthroplasty With Use of Femoral Nerve Block Versus Adductor Canal Block', 'orgStudyIdInfo': {'id': '820115'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Continuous femoral nerve block', 'description': 'patients receiving continuous femoral nerve block for analgesia after total knee arthroplasty', 'interventionNames': ['Procedure: femoral nerve block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'adductor canal block', 'description': 'adductor canal block group will receive adductor canal block for analgesia after TKA', 'interventionNames': ['Procedure: adductor canal block']}], 'interventions': [{'name': 'adductor canal block', 'type': 'PROCEDURE', 'description': 'ultrasound guided saphenous nerve block in the adductor canal', 'armGroupLabels': ['adductor canal block']}, {'name': 'femoral nerve block', 'type': 'PROCEDURE', 'description': 'ultrasound guided femoral nerve block', 'armGroupLabels': ['Continuous femoral nerve block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Nabil M Elkassabany, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}